AzTrials
AzTrials

Parkinson DiseasePROGENS-PDNCT06451419

Non Motor Symptoms in Glucocerebrosidase-related Parkinson's Disease

An observational study of Parkinson Disease, run by Juan Pablo Romero. MD, PhD at 2 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this observational study is to describe non motor symptoms in a prospective study of patients with Parkinson's disease associated to glucocerebrosidase (GBA-PD) mutations. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson Disease
What is being tested?
Tests on non motor symptoms
How many people
40 participants
Where
2 sitesSpain
Study dates
1 Jul 2024to 31 Aug 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Parkinson's disease patients whose symptoms began before they were 70 and/or those who had Parkinson's disease family history and underwent a genetic test including the following Parkinson's disease related genes: ADCY5, ANO, APOE, APP, ATP1A3, ATP9A, C19orf12, CHCHD2, CNEP1R1, COX20, CTDNEP1, DCTN1, DNAJC13, DNAJC6, ELOVO7, FJ47, FBXO7, GAK, GBA, GCDH, GCH1, GNAL, GNE, GRN, HPCA, KCTD17, KMT2B, LPIN1, LPIN2, LPIN3, LRRK2, MAPT, MCCC1, MCOLN1, NPC1, PANK2, PARK7, PDE8B, PDGFB PIN, PDGFR, PDGFR PLA2G, POLG, PRRKN, PRRKA, PSEN1, PSEN2, RAB12, RAB39B, SGCE excepto exón NM_001099401 exón 10, SLC19A3, SLC20A2, SLC30A10, SLC39A14, SLC6A3, SNCA, SNCB, SYN-1, SYNJ1, TA, TH1 TOR1A, VAC14, VPS13C (hotspot exones 11, 3, 4, 61 y 9), VPS35, XPR1 and agreed to participate in the study.

Who may be able to join

  • Aged over 18 years old.
  • Fulfill Parkinson's disease criteria of Movement Disorder Society 2015.
  • Parkinson's disease symptoms began before they were 70 and/or Parkinson's disease family history.
  • Underwent a genetic test of Parkinson's disease related genes.
  • Heterozygous mutation of glucocerebrosidase gene (only cases).
  • Absence of mutation in the Parkinson's disease genetic test (only controls).

Who cannot join

  • Suspicion of atypical parkinsonism.
  • Personal history of other neurodegenerative disorders such as Alzheimer's disease.
  • Personal history of significant cerebrovascular damage, intracraneal lessions or important craneoencephalic trauma.
  • Deep brain stimulation treatment for Parkinson's disease.
  • Moderate or severe dementia that precludes from performing the tests.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Hospital Universitario La Princesa

    Madrid, 28006

  • Universidad Francisco de Vitoria

    Pozuelo de Alarcón, Madrid, 28223

Other trials in Spain

About this study

Official title: Prospective and Controlled Glucocerebrosidase-related Parkinson's Disease Evaluation of Non Motor Symptoms (PROGENS-PD)

The goal of this observational study is to describe non motor symptoms in a prospective study of patients with Parkinson's disease associated to glucocerebrosidase (GBA-PD) mutations.

The main questions it aims to answer are:

Read more
  • Do GBA-PD patients have a greater burden of non motor symptoms?
  • How do these non motor symptoms evolve during a prospective follow up of two years?
  • Are these non motor symptoms different from those that affect Parkinson's disease patients without glucocerebrosidase mutations (non GBA-PD), in prevalence, severity and type?
  • Do these non motor symptoms correlate with objective measures such as posturography or speed reaction tests?
  • Is there a test or combination of tests that can predict the appearance of early or severe non motor symptoms?

For this reason researchers will compare the GBA-PD group of patients with a group of non mutated GBA Parkinson disease.

Participants will undergo a neurological and neuropsychological evaluation with different tests in subsequent visits for a total of 2 years.

Read the detailed description

Parkinson's disease is the second most prevalent neurodegenerative disorder worldwide. Up to date, the main risk factor for its development is carrying an heterozygous mutation in glucocerebrosidase gene (GBA). GBA codifies for a GC-ase protein that takes part in lysosomal function. The homozygous mutation of this gene gives rise to Gaucher disease, which is a lysosomal disorder. This gene has also been associated with Lewy body dementia.

The presence of an heterozygous mutation in GBA in Parkinson's disease can be found in up to 5-15% of the patients, depending on age and ethnicity. It has been described that those patients carrying the mutation can have an earlier debut of the disease.

According to non motor symptoms, patients are prone to develop earlier and more severe motor symptoms. This has been studied specially in cognitive impairment but also dysautonomia, impulse control disorder and others.

In relation to cognitive impairment these patients usually develop an earlier and more severe affection, reaching dementia states earlier in the disease. Some studies have described a worsening in cognitive function in GBA mutated patients after deep brain stimulation (DBS) to treat parkinsonian symptoms. This prevents patients from being candidates to therapies such as DBS.

For this reason, the investigators consider it important to make a proper description of non motor symptoms in GBA mutated parkinsonian patients, since this finding can help to delineate the prognosis and choose individualized treatments, regarding the suggested differences with other Parkinson's disease patients.

It is an observational prospective cohort study. Participants will be collected from a subgroup of patients that have agreed to undertake a genetic test including a panel of genes associated to Parkinson's disease.

According to the results, patients will be subdivided in two groups according to their genetic status:

  • GBA heterozygous mutations
  • Absence of genetic mutations

These patients will undergo neurologic evaluations, neuropsychological evaluations and self-administered evaluations. There will be no intervention.

The pharmacologic and other type of treatment assessments will be conducted during their regular follow up with their neurologist.

These visits will be repeated every 6 months for a total of 2 years. Total of 5 visits for each patient.

Being tested
Tests on non motor symptoms
Keywords
glucocerebrosidase heterozygous mutation, non motor symptoms, neuropsychology, posturography
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tests on non motor symptomsOther

    Neurological, neuropsychological and self-administered tests on non motor symptoms, including posturography and speed reaction times.

Study groups in NCT06451419
Study groupRoleWhat they receive
Glucocerebrosidase associated Parkinson's diseasePatients aged under 70 when symptoms began or with family history of Parkinson's disease who underwent a genetic testing including a pannel of 64 genes associated with Parkinson's diasease and who tested positive for heterozygous glucocerebrosidase mutation.
Receives: Other: Tests on non motor symptoms
Non glucocerebrosidase associated Parkinson's diaseasePatients aged under 70 when symptoms began or with family history of Parkinson's disease who underwent a genetic testing including a pannel of 64 genes associated with Parkinson's diasease and who tested negative for all the mutations in the pannel.
Receives: Other: Tests on non motor symptoms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in non motor symptoms scale from baseline to 2 years

    To determine the non motor symptoms profile and its evolution through non motor symptoms scale in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations. 30 items with total scores from 0 to 360, higher scores meaning higher non motor symptoms burden.

    Measured: 2 years

  2. Change in non motor symptoms scale from baseline to 6 months

    To determine the non motor symptoms profile and its evolution through non motor symptoms scale in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations. 30 items with total scores from 0 to 360, higher scores meaning higher non motor symptoms burden.

    Measured: 6 months

  3. Change in non motor symptoms scale from 6 months to 1 year

    To determine the non motor symptoms profile and its evolution through non motor symptoms scale in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations. 30 items with total scores from 0 to 360, higher scores meaning higher non motor symptoms burden.

    Measured: 6 months

  4. Change in non motor symptoms scale from 12 months to 18 months

    To determine the non motor symptoms profile and its evolution through non motor symptoms scale in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations. 30 items with total scores from 0 to 360, higher scores meaning higher non motor symptoms burden.

    Measured: 6 months

  5. Change in non motor symptoms scale from 18 months to 24 months

    To determine the non motor symptoms profile and its evolution through non motor symptoms scale in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations. 30 items with total scores from 0 to 360, higher scores meaning higher non motor symptoms burden.

    Measured: 6 months

Secondary outcomes (130)

  1. Change in Montreal Cognitive Assessment scale from baseline to 2 years

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Montreal Cognitive Assessment. Scores ranging from 0 to 30, with lower scores meaning higher cognitive decline.

    Measured: 2 years

  2. Change in Montreal Cognitive Assessment scale from baseline to 6 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Montreal Cognitive Assessment. Scores ranging from 0 to 30, with lower scores meaning higher cognitive decline.

    Measured: 6 months

  3. Change in Montreal Cognitive Assessment scale from 6 months to 12 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Montreal Cognitive Assessment. Scores ranging from 0 to 30, with lower scores meaning higher cognitive decline.

    Measured: 6 months

  4. Change in Montreal Cognitive Assessment scale from12 months to 18 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Montreal Cognitive Assessment. Scores ranging from 0 to 30, with lower scores meaning higher cognitive decline.

    Measured: 6 months

  5. Change in Montreal Cognitive Assessment scale from18 months to 24 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Montreal Cognitive Assessment. Scores ranging from 0 to 30, with lower scores meaning higher cognitive decline.

    Measured: 6 months

  6. Change in Parkinson's disease cognitive rating scale from baseline to 24 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Parkinson's disease cognitive rating scale, scores from 0 to 134 with lower scores meaning higher cognitive decline.

    Measured: 2 years

  7. Change in Parkinson's disease cognitive rating scale from baseline to 6 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Parkinson's disease cognitive rating scale, scores from 0 to 134 with lower scores meaning higher cognitive decline.

    Measured: 6 months

  8. Change in Parkinson's disease cognitive rating scale from 6 months to 12 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Parkinson's disease cognitive rating scale, scores from 0 to 134 with lower scores meaning higher cognitive decline.

    Measured: 6 months

  9. Change in Parkinson's disease cognitive rating scale from 12 months to 18 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Parkinson's disease cognitive rating scale, scores from 0 to 134 with lower scores meaning higher cognitive decline.

    Measured: 6 months

  10. Change in Parkinson's disease cognitive rating scale from 18 months to 24 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Parkinson's disease cognitive rating scale, scores from 0 to 134 with lower scores meaning higher cognitive decline.

    Measured: 6 months

  11. Change in Line Orientation Judgement scale from baseline to 24 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Line Orientation Judgement, scores from 0 to 30 with lower punctuation meaning higher right hemisphere disfunction.

    Measured: 2 years

  12. Change in Line Orientation Judgement scale from baseline to 6 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Line Orientation Judgement, scores from 0 to 30 with lower punctuation meaning higher right hemisphere disfunction.

    Measured: 6 months

  13. Change in Line Orientation Judgement scale from 6 months to 12 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Line Orientation Judgement, scores from 0 to 30 with lower punctuation meaning higher right hemisphere disfunction.

    Measured: 6 months

  14. Change in Line Orientation Judgement scale from 12 months to 18 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Line Orientation Judgement, scores from 0 to 30 with lower punctuation meaning higher right hemisphere disfunction.

    Measured: 6 months

  15. Change in Line Orientation Judgement scale from 18 months to 24 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Line Orientation Judgement, scores from 0 to 30 with lower punctuation meaning higher right hemisphere disfunction.

    Measured: 6 months

  16. Change in Rey figure from baseline to 24 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Rey figure test, scoring from 0 to 72 points, meaning lower punctuations altered visuoperception and visual episodic memory.

    Measured: 2 years

  17. Change in Rey figure from baseline to 6 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Rey figure test, scoring from 0 to 72 points, meaning lower punctuations altered visuoperception and visual episodic memory.

    Measured: 6 months

  18. Change in Rey figure from 6 months to 12 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Rey figure test, scoring from 0 to 72 points, meaning lower punctuations altered visuoperception and visual episodic memory.

    Measured: 6 months

  19. Change in Rey figure from 12 months to 18 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Rey figure test, scoring from 0 to 72 points, meaning lower punctuations altered visuoperception and visual episodic memory.

    Measured: 6 months

  20. Change in Rey figure from 18 months to 24 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Rey figure test, scoring from 0 to 72 points, meaning lower punctuations altered visuoperception and visual episodic memory.

    Measured: 6 months

  21. Change in Weschler Memory test from baseline to 24 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Weschler Memory test, scoring in relation to age with percentiles from 0 to 100, lower percentile meaning a greater memory disturbance.

    Measured: 2 years

  22. Change in Weschler Memory test from baseline to 6 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Weschler Memory test, scoring in relation to age with percentiles from 0 to 100, lower percentile meaning a greater memory disturbance.

    Measured: 6 months

  23. Change in Weschler Memory test from 6 months to 12 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Weschler Memory test, scoring in relation to age with percentiles from 0 to 100, lower percentile meaning a greater memory disturbance.

    Measured: 6 months

  24. Change in Weschler Memory test from 12 months to 18 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Weschler Memory test, scoring in relation to age with percentiles from 0 to 100, lower percentile meaning a greater memory disturbance.

    Measured: 6 months

  25. Change in Weschler Memory test from 18 months to 24 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Weschler Memory test, scoring in relation to age with percentiles from 0 to 100, lower percentile meaning a greater memory disturbance.

    Measured: 6 months

  26. Change in Stroop test from baseline to 24 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Stroop test with T-scores from 0 to 100, higher scores reflecting better performance and less interference on reading ability.

    Measured: 2 years

  27. Change in Stroop test from baseline to 6 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Stroop test with T-scores from 0 to 100, higher scores reflecting better performance and less interference on reading ability.

    Measured: 6 months

  28. Change in Stroop test from 6 months to 12 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Stroop test with T-scores from 0 to 100, higher scores reflecting better performance and less interference on reading ability.

    Measured: 6 months

  29. Change in Stroop test from 12 months to 18 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Stroop test with T-scores from 0 to 100, higher scores reflecting better performance and less interference on reading ability.

    Measured: 6 months

  30. Change in Stroop test from 18 months to 24 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Stroop test with T-scores from 0 to 100, higher scores reflecting better performance and less interference on reading ability.

    Measured: 6 months

  31. Change in Trail Making Test A from baseline to 24 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Trail Making Test A, with scores ranging from 0 to 100 seconds, lower scores meaning better performance.

    Measured: 2 years

  32. Change in Trail Making Test B from baseline to 24 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Trail Making Test B, with scores ranging from 0 to 300 seconds, lower scores meaning better performance.

    Measured: 2 years

  33. Change in Trail Making Test A from baseline to 6 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Trail Making Test A, with scores ranging from 0 to 100 seconds, lower scores meaning better performance.

    Measured: 6 months

  34. Change in Trail Making Test B from baseline to 6 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Trail Making Test A, with scores ranging from 0 to 100 seconds, lower scores meaning better performance.

    Measured: 6 months

  35. Change in Trail Making Test A from 6 months to 12 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Trail Making Test B, with scores ranging from 0 to 300 seconds, lower scores meaning better performance.

    Measured: 6 months

  36. Change in Trail Making Test B from 6 months to 12 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Trail Making Test B, with scores ranging from 0 to 300 seconds, lower scores meaning better performance.

    Measured: 6 months

  37. Change in Trail Making Test A from 12 months to 18 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Trail Making Test A, with scores ranging from 0 to 100 seconds, lower scores meaning better performance.

    Measured: 6 months

  38. Change in Trail Making Test B from 12 months to 18 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Trail Making Test B, with scores ranging from 0 to 300 seconds, lower scores meaning better performance.

    Measured: 6 months

  39. Change in Trail Making Test A from 18 months to 24 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Trail Making Test A, with scores ranging from 0 to 100 seconds, lower scores meaning better performance.

    Measured: 6 months

  40. Change in Trail Making Test B from 18 months to 24 months

    To determine the cognitive profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Trail Making Test B, with scores ranging from 0 to 300 seconds, lower scores meaning better performance.

    Measured: 6 months

  41. Change in Questionnaire for impulsive-compulsive disorders in Parkinson's disease (QUIP-RS) from baseline to 2 years

    To determine impulse control disorder in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using the Questionnaire for impulsive-compulsive disorders, scoring from 0 to 16 with lower scores meaning less impulsive-compulsive symptoms.

    Measured: 2 years

  42. Change in Questionnaire for impulsive-compulsive disorders in Parkinson's disease (QUIP-RS) from baseline to 6 months

    To determine impulse control disorder in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using the Questionnaire for impulsive-compulsive disorders, scoring from 0 to 16 with lower scores meaning less impulsive-compulsive symptoms.

    Measured: 6 months

  43. Change in Questionnaire for impulsive-compulsive disorders in Parkinson's disease (QUIP-RS) from 6 months to 12 months

    To determine impulse control disorder in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using the Questionnaire for impulsive-compulsive disorders, scoring from 0 to 16 with lower scores meaning less impulsive-compulsive symptoms.

    Measured: 6 months

  44. Change in Questionnaire for impulsive-compulsive disorders in Parkinson's disease (QUIP-RS) from 12 months to 18 months

    To determine impulse control disorder in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using the Questionnaire for impulsive-compulsive disorders, scoring from 0 to 16 with lower scores meaning less impulsive-compulsive symptoms.

    Measured: 6 months

  45. Change in Questionnaire for impulsive-compulsive disorders in Parkinson's disease (QUIP-RS) from 18 months to 24 months

    To determine impulse control disorder in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using the Questionnaire for impulsive-compulsive disorders, scoring from 0 to 16 with lower scores meaning less impulsive-compulsive symptoms.

    Measured: 6 months

  46. Change in Neuropsychiatric inventory from baseline to 2 years

    To determine neuropsychiatric profile in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Neuropsychiatric inventory, scoring from 0 to 144 with higher scores meaning greater neuropsychiatric symptoms.

    Measured: 2 years

  47. Change in Neuropsychiatric inventory from baseline to 6 months

    To determine neuropsychiatric profile in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Neuropsychiatric inventory, scoring from 0 to 144 with higher scores meaning greater neuropsychiatric symptoms.

    Measured: 6 months

  48. Change in Neuropsychiatric inventory from 6 months to 12 months

    To determine neuropsychiatric profile in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Neuropsychiatric inventory, scoring from 0 to 144 with higher scores meaning greater neuropsychiatric symptoms.

    Measured: 6 months

  49. Change in Neuropsychiatric inventory from 12 months to 18 months

    To determine neuropsychiatric profile in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Neuropsychiatric inventory, scoring from 0 to 144 with higher scores meaning greater neuropsychiatric symptoms.

    Measured: 6 months

  50. Change in Neuropsychiatric inventory from 18 months to 24 months

    To determine neuropsychiatric profile in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Neuropsychiatric inventory, scoring from 0 to 144 with higher scores meaning greater neuropsychiatric symptoms.

    Measured: 6 months

  51. Change in Apathy Evaluation Scale from baseline to 24 months

    To determine changes in apathy in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Apathy Evaluation Scale. The total score ranges from 18 to 72, with higher scores indicating more apathy.

    Measured: 2 years

  52. Change in Apathy Evaluation Scale from baseline to 6 months

    To determine changes in apathy in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Apathy Evaluation Scale. The total score ranges from 18 to 72, with higher scores indicating more apathy.

    Measured: 6 months

  53. Change in Apathy Evaluation Scale from 6 months to 12 months

    To determine changes in apathy in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Apathy Evaluation Scale. The total score ranges from 18 to 72, with higher scores indicating more apathy.

    Measured: 6 months

  54. Change in Apathy Evaluation Scale from 12 months to 18 months

    To determine changes in apathy in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Apathy Evaluation Scale. The total score ranges from 18 to 72, with higher scores indicating more apathy.

    Measured: 6 months

  55. Change in Apathy Evaluation Scale from 18 months to 24 months

    To determine changes in apathy in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Apathy Evaluation Scale. The total score ranges from 18 to 72, with higher scores indicating more apathy.

    Measured: 6 months

  56. Change in Beck Depression Inventory from baseline to 24 months

    To determine changes in depression in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Beck Depression Inventory with scores from 0 to 63, with higher scores meaning more depressive symptoms.

    Measured: 2 years

  57. Change in Beck Depression Inventory from baseline to 6 months

    To determine changes in depression in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Beck Depression Inventory with scores from 0 to 63, with higher scores meaning more depressive symptoms.

    Measured: 6 months

  58. Change in Beck Depression Inventory from 6 months to 12 months

    To determine changes in depression in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Beck Depression Inventory with scores from 0 to 63, with higher scores meaning more depressive symptoms.

    Measured: 6 months

  59. Change in Beck Depression Inventory from 12 months to 18 months

    To determine changes in depression in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Beck Depression Inventory with scores from 0 to 63, with higher scores meaning more depressive symptoms.

    Measured: 6 months

  60. Change in Beck Depression Inventory from 18 months to 24 months

    To determine changes in depression in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Beck Depression Inventory with scores from 0 to 63, with higher scores meaning more depressive symptoms.

    Measured: 6 months

  61. Change in Stai-trait Anxiety Inventory from baseline to 24 months

    To determine changes in anxiety in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using State-trait Anxiety Inventory, scoring from 20 to 80, with higher punctuations meaning higher anxiety symptoms.

    Measured: 2 years

  62. Change in Stai-trait Anxiety Inventory from baseline to 6 months

    To determine changes in anxiety in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using State-trait Anxiety Inventory, scoring from 20 to 80, with higher punctuations meaning higher anxiety symptoms.

    Measured: 6 months

  63. Change in Stai-trait Anxiety Inventory from 6 months to 12 months

    To determine changes in anxiety in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using State-trait Anxiety Inventory, scoring from 20 to 80, with higher punctuations meaning higher anxiety symptoms.

    Measured: 6 months

  64. Change in Stai-trait Anxiety Inventory from 12 months to 18 months

    To determine changes in anxiety in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using State-trait Anxiety Inventory, scoring from 20 to 80, with higher punctuations meaning higher anxiety symptoms.

    Measured: 6 months

  65. Change in Stai-trait Anxiety Inventory from 18 months to 24 months

    To determine changes in anxiety in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using State-trait Anxiety Inventory, scoring from 20 to 80, with higher punctuations meaning higher anxiety symptoms.

    Measured: 6 months

  66. Change in Parkinson's disease sleep scale from baseline to 24 months

    To determine the sleep profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Parkinson's disease sleep scale, with scores from 0 to 150, the highest meaning less sleep symptoms.

    Measured: 2 years

  67. Change in Parkinson's disease sleep scale from baseline to 6 months

    To determine the sleep profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Parkinson's disease sleep scale, with scores from 0 to 150, the highest meaning less sleep symptoms.

    Measured: 6 months

  68. Change in Parkinson's disease sleep scale from 6 months to 12 months

    To determine the sleep profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Parkinson's disease sleep scale, with scores from 0 to 150, the highest meaning less sleep symptoms.

    Measured: 6 months

  69. Change in Parkinson's disease sleep scale from 12 months to 18 months

    To determine the sleep profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Parkinson's disease sleep scale, with scores from 0 to 150, the highest meaning less sleep symptoms.

    Measured: 6 months

  70. Change in Parkinson's disease sleep scale from 18 months to 24 months

    To determine the sleep profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Parkinson's disease sleep scale, with scores from 0 to 150, the highest meaning less sleep symptoms.

    Measured: 6 months

  71. Change in Rapid Eye Movement Sleep Behavior Disorder Screening Questionnaire from baseline to 24 months

    To determine the presence and symptoms of Rapid Eye Movement Sleep Behaviour Disorder in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Rapid Eye Movement Sleep Screening Questionnaire, scoring from 0 to 13 with higher scores meaning more Rapid Eye Movement sleep problems.

    Measured: 2 years

  72. Change in REM Sleep Behavior Disorder Screening Questionnaire from baseline to 6 months

    To determine the presence and symptoms of Rapid Eye Movement Sleep Behaviour Disorder in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Rapid Eye Movement Sleep Screening Questionnaire, scoring from 0 to 13 with higher scores meaning more Rapid Eye Movement sleep problems.

    Measured: 6 months

  73. Change in REM Sleep Behavior Disorder Screening Questionnaire from to 6 months to 12 months

    To determine the presence and symptoms of Rapid Eye Movement Sleep Behaviour Disorder in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Rapid Eye Movement Sleep Screening Questionnaire, scoring from 0 to 13 with higher scores meaning more Rapid Eye Movement sleep problems.

    Measured: 6 months

  74. Change in REM Sleep Behavior Disorder Screening Questionnaire from to 12 months to 18 months

    To determine the presence and symptoms of Rapid Eye Movement Sleep Behaviour Disorder in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Rapid Eye Movement Sleep Screening Questionnaire, scoring from 0 to 13 with higher scores meaning more Rapid Eye Movement sleep problems.

    Measured: 6 months

  75. Change in REM Sleep Behavior Disorder Screening Questionnaire from to 18 months to 24 months

    To determine the presence and symptoms of Rapid Eye Movement Sleep Behaviour Disorder in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Rapid Eye Movement Sleep Screening Questionnaire, scoring from 0 to 13 with higher scores meaning more Rapid Eye Movement sleep problems.

    Measured: 6 months

  76. Change in Epworth Sleepiness Scale from baseline to 24 months

    To determine the presence and severity of somnolence in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Epworth Sleepiness Scale, scoring from 0 to 24, with higher scores meaning higher sleeppiness.

    Measured: 2 years

  77. Change in Epworth Sleepiness Scale from baseline to 6 months

    To determine the presence and severity of somnolence in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Epworth Sleepiness Scale, scoring from 0 to 24, with higher scores meaning higher sleeppiness.

    Measured: 6 months

  78. Change in Epworth Sleepiness Scale from 6 months to 12 months

    To determine the presence and severity of somnolence in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Epworth Sleepiness Scale, scoring from 0 to 24, with higher scores meaning higher sleeppiness.

    Measured: 6 months

  79. Change in Epworth Sleepiness Scale from 12 months to 18 months

    To determine the presence and severity of somnolence in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Epworth Sleepiness Scale, scoring from 0 to 24, with higher scores meaning higher sleeppiness.

    Measured: 6 months

  80. Change in Epworth Sleepiness Scale from 18 months to 24 months

    To determine the presence and severity of somnolence in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Epworth Sleepiness Scale, scoring from 0 to 24, with higher scores meaning higher sleeppiness.

    Measured: 6 months

  81. Change in Restless Legs Syndrome Rating Scale from baseline to 24 months

    To determine the presence and severity of restless leg syndrome in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Restless Legs Syndrome Rating Scale, scoring from 0 to 40 with higher scores meaning greater restless legs syndrome symptoms.

    Measured: 2 years

  82. Change in Restless Legs Syndrome Rating Scale from baseline to 6 months

    To determine the presence and severity of restless leg syndrome in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Restless Legs Syndrome Rating Scale, scoring from 0 to 40 with higher scores meaning greater restless legs syndrome symptoms.

    Measured: 6 months

  83. Change in Restless Legs Syndrome Rating Scale from 6 months to 12 months

    To determine the presence and severity of restless leg syndrome in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Restless Legs Syndrome Rating Scale, scoring from 0 to 40 with higher scores meaning greater restless legs syndrome symptoms.

    Measured: 6 months

  84. Change in Restless Legs Syndrome Rating Scale from 12 months to 18 months

    To determine the presence and severity of restless leg syndrome in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Restless Legs Syndrome Rating Scale, scoring from 0 to 40 with higher scores meaning greater restless legs syndrome symptoms.

    Measured: 6 months

  85. Change in Restless Legs Syndrome Rating Scale from 18 months to 24 months

    To determine the presence and severity of restless leg syndrome in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Restless Legs Syndrome Rating Scale, scoring from 0 to 40 with higher scores meaning greater restless legs syndrome symptoms.

    Measured: 6 months

  86. Change in Berg balance scale from baseline to 24 months

    To determine changes in balance in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Berg Balance scale with ranges from 0 to 56. The lower score, the more at risk you of losing balance.

    Measured: 2 years

  87. Change in Berg balance scale from baseline to 6 months

    To determine changes in balance in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Berg Balance scale with ranges from 0 to 56. The lower score, the more at risk you of losing balance.

    Measured: 6 months

  88. Change in Berg balance scale from 6 months to 12 months

    To determine changes in balance in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Berg Balance scale with ranges from 0 to 56. The lower score, the more at risk you of losing balance.

    Measured: 6 months

  89. Change in Berg balance scale from 12 months to 18 months

    To determine changes in balance in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Berg Balance scale with ranges from 0 to 56. The lower score, the more at risk you of losing balance.

    Measured: 6 months

  90. Change in Berg balance scale from 18 months to 24 months

    To determine changes in balance in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using Berg Balance scale with ranges from 0 to 56. The lower score, the more at risk you of losing balance.

    Measured: 6 months

  91. Change in limits of stability from baseline to 24 months

    To determine changes in balance in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using % of performance regarding normalized limits of stability for reference sample, with values between 0-100%

    Measured: 2 years

  92. Change in limits of stability from baseline to 6 months

    To determine changes in balance in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using % of performance regarding normalized limits of stability for reference sample, with values between 0-100%

    Measured: 6 months

  93. Change in limits of stability from 6 months to 12 months

    TTo determine changes in balance in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using % of performance regarding normalized limits of stability for reference sample, with values between 0-100%

    Measured: 6 months

  94. Change in limits of stability from 12 months to 18 months

    To determine changes in balance in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using % of performance regarding normalized limits of stability for reference sample, with values between 0-100%

    Measured: 6 months

  95. Change in limits of stability from 18 months to 24 months

    To determine changes in balance in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using % of performance regarding normalized limits of stability for reference sample, with values between 0-100%

    Measured: 6 months

  96. Change in speed reaction test from baseline to 24 months

    To determine changes in speed reaction in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using speed reaction tests measuring the time until response in seconds, with scores from 0 with no maximum value.

    Measured: 2 years

  97. Change in speed reaction test from baseline to 6 months

    TTo determine changes in speed reaction in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using speed reaction tests measuring the time until response in seconds, with scores from 0 with no maximum value.

    Measured: 6 months

  98. Change in speed reaction test from 6 months to 12 months

    To determine changes in speed reaction in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using speed reaction tests measuring the time until response in seconds, with scores from 0 with no maximum value.

    Measured: 6 months

  99. Change in speed reaction test from 12 months to 18 months

    To determine changes in speed reaction in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using speed reaction tests measuring the time until response in seconds, with scores from 0 with no maximum value.

    Measured: 6 months

  100. Change in speed reaction test from 18 months to 24 months

    To determine changes in speed reaction in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations, by using speed reaction tests measuring the time until response in seconds, with scores from 0 with no maximum value.

    Measured: 6 months

  101. Change in Movement Disorder's Society- Unified Parkinson's Disease Rating Scale part II scale from baseline to 24 months

    To determine the motor profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations by using Movement Disorder's Society- Unified Parkinson's Disease Rating Scale part II, scoring from 0 to 52, higher scores meaning a greater Parkinson's symptoms burden.

    Measured: 2 years

  102. Change in Movement Disorder's Society- Unified Parkinson's Disease Rating Scale part II from baseline to 6 months

    To determine the motor profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations by using Movement Disorder's Society- Unified Parkinson's Disease Rating Scale part II, scoring from 0 to 52, higher scores meaning a greater Parkinson's symptoms burden.

    Measured: 6 months

  103. Change in Movement Disorder's Society- Unified Parkinson's Disease Rating Scale part II from 6 months to 12 months

    To determine the motor profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations by using Movement Disorder's Society- Unified Parkinson's Disease Rating Scale part II, scoring from 0 to 52, higher scores meaning a greater Parkinson's symptoms burden.

    Measured: 6 months

  104. Change in Movement Disorder's Society- Unified Parkinson's Disease Rating Scale part II from 12 months to 18 months

    To determine the motor profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations by using Movement Disorder's Society- Unified Parkinson's Disease Rating Scale part II, scoring from 0 to 52, higher scores meaning a greater Parkinson's symptoms burden.

    Measured: 6 months

  105. Change in Movement Disorder's Society- Unified Parkinson's Disease Rating Scale part II from 18 months to 24 months

    To determine the motor profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations by using Movement Disorder's Society- Unified Parkinson's Disease Rating Scale part II, scoring from 0 to 52, higher scores meaning a greater Parkinson's symptoms burden.

    Measured: 6 months

  106. Change in Movement Disorder's Society- Unified Parkinson's Disease Rating Scale part III scale from baseline to 24 months

    To determine the motor profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations by using Movement Disorder's Society- Unified Parkinson's Disease Rating Scale part III, scoring from 0 to 132, higher scores meaning a greater Parkinson's symptoms burden.

    Measured: 2 years

  107. Change in Movement Disorder's Society- Unified Parkinson's Disease Rating Scale part III scale from baseline to 6 months

    To determine the motor profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations by using Movement Disorder's Society- Unified Parkinson's Disease Rating Scale part III, scoring from 0 to 132, higher scores meaning a greater Parkinson's symptoms burden.

    Measured: 6 months

  108. Change in Movement Disorder's Society- Unified Parkinson's Disease Rating Scale part III scale from 6 months to 12 months

    To determine the motor profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations by using Movement Disorder's Society- Unified Parkinson's Disease Rating Scale part III, scoring from 0 to 132, higher scores meaning a greater Parkinson's symptoms burden.

    Measured: 6 months

  109. Change in Movement Disorder's Society- Unified Parkinson's Disease Rating Scale part III scale from 12 months to 18 months

    To determine the motor profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations by using Movement Disorder's Society- Unified Parkinson's Disease Rating Scale part III, scoring from 0 to 132, higher scores meaning a greater Parkinson's symptoms burden.

    Measured: 6 months

  110. Change in Movement Disorder's Society- Unified Parkinson's Disease Rating Scale part III scale from 18 months to 24 months

    To determine the motor profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations by using Movement Disorder's Society- Unified Parkinson's Disease Rating Scale part III, scoring from 0 to 132, higher scores meaning a greater Parkinson's symptoms burden.

    Measured: 6 months

  111. Change in Movement Disorder's Society- Unified Parkinson's Disease Rating Scale part IV scale from baseline to 24 months

    To determine the motor profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations by using Movement Disorder's Society- Unified Parkinson's Disease Rating Scale part IV, scoring from 0 to 24, higher scores meaning a greater Parkinson's symptoms burden.

    Measured: 2 years

  112. Change in Movement Disorder's Society- Unified Parkinson's Disease Rating Scale part IV scale from baseline to 6 months

    To determine the motor profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations by using Movement Disorder's Society- Unified Parkinson's Disease Rating Scale part IV, scoring from 0 to 24, higher scores meaning a greater Parkinson's symptoms burden.

    Measured: 6 months

  113. Change in Movement Disorder's Society- Unified Parkinson's Disease Rating Scale part IV scale from 6 months to 12 months

    To determine the motor profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations by using Movement Disorder's Society- Unified Parkinson's Disease Rating Scale part IV, scoring from 0 to 24, higher scores meaning a greater Parkinson's symptoms burden.

    Measured: 6 months

  114. Change in Movement Disorder's Society- Unified Parkinson's Disease Rating Scale pary IV scale from 12 months to 18 months

    To determine the motor profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations by using Movement Disorder's Society- Unified Parkinson's Disease Rating Scale part IV, scoring from 0 to 24, higher scores meaning a greater Parkinson's symptoms burden.

    Measured: 6 months

  115. Change in Movement Disorder's Society- Unified Parkinson's Disease Rating Scale part IV scale from 18 months to 24 months

    To determine the motor profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations by using Movement Disorder's Society- Unified Parkinson's Disease Rating Scale part IV, scoring from 0 to 24, higher scores meaning a greater Parkinson's symptoms burden.

    Measured: 6 months

  116. Change in Hoehn and Yahr scale from baseline to 24 months

    To determine the motor profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations by using Hoehn and Yahr scale, scores from 1-5, with lower scores meaning a lower motor symptom burden.

    Measured: 2 years

  117. Change in Hoehn and Yahr scale from baseline to 6 months

    To determine the motor profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations by using Hoehn and Yahr scale, scores from 1-5, with lower scores meaning a lower motor symptom burden.

    Measured: 6 months

  118. Change in Hoehn and Yahr scale from 6 months to 12 months

    To determine the motor profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations by using Hoehn and Yahr scale, scores from 1-5, with lower scores meaning a lower motor symptom burden.

    Measured: 6 months

  119. Change in Hoehn and Yahr scale from 12 months to 18 months

    To determine the motor profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations by using Hoehn and Yahr scale, scores from 1-5, with lower scores meaning a lower motor symptom burden.

    Measured: 6 months

  120. Change in Hoehn and Yahr scale from 18 months to 24 months

    To determine the motor profile of glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations by using Hoehn and Yahr scale, scores from 1-5, with lower scores meaning a lower motor symptom burden.

    Measured: 6 months

  121. Change in Parkinson's disease Questionnaire-39 from baseline to 24 months

    To determine the repercusion of Parkinson's disease in daily activies in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations by using Parkinson's disease Questionnaire-39, scores from 0 to 100 with higher scores meaning greater repercussion in daily activities.

    Measured: 2 years

  122. Change in Parkinson's disease Questionnaire-39 from baseline to 6 months

    To determine the repercusion of Parkinson's disease in daily activies in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations by using Parkinson's disease Questionnaire-39, scores from 0 to 100 with higher scores meaning greater repercussion in daily activities.

    Measured: 6 months

  123. Change in Parkinson's disease Questionnaire-39 from 6 months to 12 months

    To determine the repercusion of Parkinson's disease in daily activies in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations by using Parkinson's disease Questionnaire-39, scores from 0 to 100 with higher scores meaning greater repercussion in daily activities.

    Measured: 6 months

  124. Change in Parkinson's disease Questionnaire-39 from 12 months to 18 months

    To determine the repercusion of Parkinson's disease in daily activies in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations by using Parkinson's disease Questionnaire-39, scores from 0 to 100 with higher scores meaning greater repercussion in daily activities.

    Measured: 6 months

  125. Change in Parkinson's disease Questionnaire-39 from 18 months to 24 months

    To determine the repercusion of Parkinson's disease in daily activies in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations by using Parkinson's disease Questionnaire-39, scores from 0 to 100 with higher scores meaning greater repercussion in daily activities.

    Measured: 6 months

  126. Change in number of Parkinson's disease treatments from baseline to 24 months

    To determine the changes in number of Parkinsons disease drugs during the course of the disease in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations.

    Measured: 2 years

  127. Change in number of Parkinson's disease treatments from baseline to 6 months

    To determine the changes in number of Parkinsons disease drugs during the course of the disease in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations.

    Measured: 6 months

  128. Change in number of Parkinson's disease treatments from 6 months to 12 months

    To determine the changes in number of Parkinsons disease drugs during the course of the disease in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations.

    Measured: 6 months

  129. Change in number of Parkinson's disease treatments from 12 to 18 months

    To determine the changes in number of Parkinsons disease drugs during the course of the disease in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations.

    Measured: 6 months

  130. Change in number of Parkinson's disease treatments from 18 to 24 months

    To determine the changes in number of Parkinsons disease drugs during the course of the disease in glucocerebrosidase mutated Parkinson's disease in comparison with those without mutations.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2024
  2. Study start1 Jul 2024 (estimated)
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion31 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06451419
Sponsor's protocol ID
5564
Acronym
PROGENS-PD
Status last verified
Jun 2024
First submitted
21 May 2024
Last updated
28 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Sidransky E, Nalls MA, Aasly JO, Aharon-Peretz J, Annesi G, Barbosa ER, Bar-Shira A, Berg D, Bras J, Brice A, Chen CM, Clark LN, Condroyer C, De Marco EV, Durr A, Eblan MJ, Fahn S, Farrer MJ, Fung HC, Gan-Or Z, Gasser T, Gershoni-Baruch R, Giladi N, Griffith A, Gurevich T, Januario C, Kropp P, Lang AE, Lee-Chen GJ, Lesage S, Marder K, Mata IF, Mirelman A, Mitsui J, Mizuta I, Nicoletti G, Oliveira C, Ottman R, Orr-Urtreger A, Pereira LV, Quattrone A, Rogaeva E, Rolfs A, Rosenbaum H, Rozenberg R, Samii A, Samaddar T, Schulte C, Sharma M, Singleton A, Spitz M, Tan EK, Tayebi N, Toda T, Troiano AR, Tsuji S, Wittstock M, Wolfsberg TG, Wu YR, Zabetian CP, Zhao Y, Ziegler SG. Multicenter analysis of glucocerebrosidase mutations in Parkinson's disease. N Engl J Med. 2009 Oct 22;361(17):1651-61. doi: 10.1056/NEJMoa0901281.

    PubMed 19846850

  • Barkhuizen M, Anderson DG, Grobler AF. Advances in GBA-associated Parkinson's disease--Pathology, presentation and therapies. Neurochem Int. 2016 Feb;93:6-25. doi: 10.1016/j.neuint.2015.12.004. Epub 2015 Dec 30.

    PubMed 26743617

  • Brockmann K, Srulijes K, Pflederer S, Hauser AK, Schulte C, Maetzler W, Gasser T, Berg D. GBA-associated Parkinson's disease: reduced survival and more rapid progression in a prospective longitudinal study. Mov Disord. 2015 Mar;30(3):407-11. doi: 10.1002/mds.26071. Epub 2014 Dec 1.

    PubMed 25448271

  • Leocadi M, Canu E, Donzuso G, Stojkovic T, Basaia S, Kresojevic N, Stankovic I, Sarasso E, Piramide N, Tomic A, Markovic V, Petrovic I, Stefanova E, Kostic VS, Filippi M, Agosta F. Longitudinal clinical, cognitive, and neuroanatomical changes over 5 years in GBA-positive Parkinson's disease patients. J Neurol. 2022 Mar;269(3):1485-1500. doi: 10.1007/s00415-021-10713-4. Epub 2021 Jul 23.

    PubMed 34297177

  • Swan M, Doan N, Ortega RA, Barrett M, Nichols W, Ozelius L, Soto-Valencia J, Boschung S, Deik A, Sarva H, Cabassa J, Johannes B, Raymond D, Marder K, Giladi N, Miravite J, Severt W, Sachdev R, Shanker V, Bressman S, Saunders-Pullman R. Neuropsychiatric characteristics of GBA-associated Parkinson disease. J Neurol Sci. 2016 Nov 15;370:63-69. doi: 10.1016/j.jns.2016.08.059. Epub 2016 Aug 30.

    PubMed 27772789

  • Malek N, Weil RS, Bresner C, Lawton MA, Grosset KA, Tan M, Bajaj N, Barker RA, Burn DJ, Foltynie T, Hardy J, Wood NW, Ben-Shlomo Y, Williams NW, Grosset DG, Morris HR; PRoBaND clinical consortium. Features of GBA-associated Parkinson's disease at presentation in the UK Tracking Parkinson's study. J Neurol Neurosurg Psychiatry. 2018 Jul;89(7):702-709. doi: 10.1136/jnnp-2017-317348. Epub 2018 Jan 29.

    PubMed 29378790

  • Ren J, Zhou G, Wang Y, Zhang R, Guo Z, Zhou H, Zheng H, Sun Y, Ma C, Lu M, Liu W. Association of GBA genotype with motor and cognitive decline in Chinese Parkinson's disease patients. Front Aging Neurosci. 2023 Feb 10;15:1091919. doi: 10.3389/fnagi.2023.1091919. eCollection 2023.

    PubMed 36845659

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease, run by Juan Pablo Romero. MD, PhD at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in non motor symptoms scale from baseline to 2 years (time frame: 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06451419, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.

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