PolyneuropathyPromparkNCT06745011
Prodromal Model of Parkinson's Disease Confined to The Peripheral Nervous System
An observational study of Polyneuropathy and Alpha-Synucleinopathy, run by University of Aarhus at 1 site in Denmark.
Trial summary
Description of a method to detect Parkinson's disease or Parkinson's-like disease at an early stage (Prodromal Parkinson's Disease) where damage is still confined to the peripheral nervous system damage. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Polyneuropathy, Alpha-Synucleinopathy, Lewy Body Disease
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 13 May 2024to 1 May 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with definite polyneuropathy (confirmed by nerve conductions study) diagnosed in Jutland, Denmark and orthostatic hypotension or non-nocturnal blood pressure reduction.
Who may be able to join
- Definite polyneuropathy without known etiology (idiopathic) AND orthostatic hypotension (active stand test) OR non-nocturnal blood pressure reduction (24 hour blood pressure measurement)
Who cannot join
- Known etiology of polyneuropathy
- A diagnosis of either dementia, Parkinson's disease, Dementia with Lewy Bodies or Multiple System Atrophy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Institute of Clinical Medicine, Aarhus University
Aarhus, Jutland, 8200
About this study
Description of a method to detect Parkinson's disease or Parkinson's-like disease at an early stage (Prodromal Parkinson's Disease) where damage is still confined to the peripheral nervous system damage. Simultaneous collection of biological material to establish a biobank for use as prognostic biomarkers for the development of Parkinson's disease and other neurodegenerative diseases in which pathological alpha-synuclein deposits accumulate.
Read the detailed description
Primary aim (baseline):
To assess the prevalence of isolated REM Sleep Behavior Disorder (iRBD) or REM sleep without atonia (RSWA) in patients with idiopathic polyneuropathy with as to without abnormal cardiac 123I-metaiodobenzylguanidine (MIBG) scintigraphy (assessment of cardiac sympathetic innervation)
Secondary aim (baseline):
To assess the prevalence of Parkinson's Disease (PD), Dementia with Lewy bodies (DLB) and Multiple System Atrophy (MSA) in patients with idiopathic polyneuropathy.
Hypothesis (baseline):
iRBD is more prevalent in patients known with idiopathic polyneuropathy and abnormal sympathetic innervation of the heart (assessed by cardiac 123I-MIBG scintigraphy) as compared to normal cardiac sympathetic innervation.
Primary aim (5-follow-up):
To assess whether patients with idiopathic polyneuropathy develop RSWA, iRBD, PD, DLB or MSA over a periode of five years.
Hypothesis (5-follow-up):
Patients known with idiopathic polyneuropathy and abnormal sympathetic innervation of the heart (assessed by cardiac 123I-MIBG scintigraphy) will convert to RSWA, iRBD, PD, DLB or MSA more often than those with normal cardiac sympathetic innervation.
Methods:
Clinical evaluation in combination with questionnaires, multi-modal imaging methods and polysomnography.
(Assessment of neuropathy: Neuropathy Impairment Score - Lower Leg (NIS-LL), Utah Early Neurological Scale (UENS), Kumamoto Neurological Scale and autonomic function test including Tilt table Test, Valsalva Maneuver, Deep Breathing Test, The Quantitative sensory axon reflex test (QSART). Cognition: The Montreal Cognitive Assessment (MoCA), Trail making Test B (TMT-B). Motor function: MDS-Unified Parkinson's Disease Rating Scale part III (MDS-UPDRS-III). Multi-modal imaging: cardiac 123I-MIBG scintigraphy, PE2I-PET-CT, MR-neuromelanin. Sleep: REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ), one-night video polysomnography (PSG).)
Statistics:
The researchers expect to enroll 100 participants with idiopathic polyneuropathy and orthostatic hypotension or abnormal 24-hour blood pressure measurement (non-nocturnal blood pressure dip) who have undergone cardiac 123I-MIBG scintigraphy. Based on preliminary results, the investigators expect that 1/3 (30 participants) will have abnormal cardiac MIBG scintigraphy (cases; suggested to have prodromal PD or DLB) and 2/3 (70 participants) with normal MIBG scintigraphy (controls). The prevalence of iRBD detected by video-PSG is assumed to be 5% in participants with normal cardiac MIBG scintigraphy and 35% in participants with abnormal MIBG scintigraphy. To achieve a power of 88%, 81 participants have to be included (54 with normal and 27 with abnormal cardiac MIBG scintigraphy). Power calculation was based on Fisher's exact-test. Fisher's exact test was used because of an expected small number of participants with video PSG-detected iRBD.
Biobank:
Simultaneously collection of body tissue/fluids: skin, blood, cerebrospinal fluid and faeces. Analysis of the levels of phosphorylated tau, total-tau and amyloid beta in cerebrospinal fluid is performed at baseline.
- Conditions
- Polyneuropathy, Alpha-Synucleinopathy, Lewy Body Disease, Parkinson Disease (PD), Lewy Body Dementia (LBD), Multiple System Atrophy
- Keywords
- Isolated Rapid Eye Movement Sleep Behavior Disorder, REM Sleep Behavior Disorder, Polyneuropathy, Idiopathic Polyneuropathy, Cardiac MIBG Scintigraphy, Prodromal Lewy Body Disease, Lewy Body Disease, Alpha-synucleinopathy
- Medical subject headings
- Polyneuropathies, Synucleinopathies, Lewy Body Disease, Parkinson Disease, Multiple System Atrophy, Pure Autonomic Failure, REM Sleep Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic polyneuropathy with abnormal cardiac 123I-MIBG scintigraphy | Participants diagnosed with polyneuropathy, orthostatic hypotension or non-nocturnal blood pressure dip and abnormal cardiac 123I-MIBG scintigraphy (cardiac sympathetic dysfunction) | |
| Idiopathic polyneuropathy with normal cardiac 123I-MIBG scintigraphy | Participants diagnosed with polyneuropathy, orthostatic hypotension or non-nocturnal blood pressure dip and normal cardiac 123I-MIBG scintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with REM sleep behavior disorder (RBD)
RBD-status will be assessed by one-night video-polysomnography and REM Sleep Behavior Disorder Screening questionnaire (RBDSQ). Diagnosis of RBD according to American Academy of Sleep Medicine (AASM) criteria.
Measured: RBD-status is assessed at two time point: Baseline (at the time of enrollment) and 5-year follow-up
Secondary outcomes (1)
Number of participants with Parkinson's Disease (PD) or related alpha-synucleinopathies (Dementia with Lewy bodies (DLB), Multiple System atrophy (MSA)), REM-Sleep without atonia (RSWA)
Diagnosis of Parkinson's Disease according to Movement Disorder Society (MDS) Clinical Diagnostic Criteria (Postuma et al., 2015) supported by dopamine transporter imaging (18F-PE2I-PET).
Diagnosis of Dementia with Lewy bodies according to the Dementia with Lewy Bodies Consortium (Mckeith et al., 2017)
Diagnosis of Multiple System Atrophy according to MDS Clinical Diagnostic Criteria (Whenning et al., 2022)
REM-sleep without atonia (RSWA) is assessed by one-night video-polysomnography
Measured: Assessed at baseline (at the time of enrollment) and at 5-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start13 May 2024
- Primary completion1 May 2031 (estimated)
- Study completion1 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolyneuropathyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Novo Nordisk A/S
- Responsible party
- Sponsor
- Investigators
- Astrid J. Terkelsen, MD, DrMedSc, PhD, Professor, Principal investigator, Department of clinical medicine, Aarhus University and Department of Neurology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745011
- Sponsor's protocol ID
- 1-10-72-20-24
- Other IDs
- NNF230C0082689
- Acronym
- Prompark
- Status last verified
- Nov 2024
- First submitted
- 17 Dec 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prodromal Model of Parkinson's Disease Confined to The Peripheral Nervous System
- ClinicalTrials.gov ID
- NCT06745011
- Acronym / sponsor ID
- Prompark / 1-10-72-20-24
- Conditions
- Polyneuropathy, Alpha-Synucleinopathy, Lewy Body Disease, Parkinson Disease (PD), Lewy Body Dementia (LBD), Multiple System Atrophy
- Keywords
- Isolated Rapid Eye Movement Sleep Behavior Disorder, REM Sleep Behavior Disorder, Polyneuropathy, Idiopathic Polyneuropathy, Cardiac MIBG Scintigraphy, Prodromal Lewy Body Disease, Lewy Body Disease, Alpha-synucleinopathy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Novo Nordisk A/S
- Study start
- 13 May 2024 (actual)
- Primary completion
- 1 May 2031 (estimated)
- Study completion
- 1 May 2031 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Description of a method to detect Parkinson's disease or Parkinson's-like disease at an early stage (Prodromal Parkinson's Disease) where damage is still confined to the peripheral nervous system damage. Simultaneous collection of biological material to establish a biobank for use as prognostic biomarkers for the development of Parkinson's disease and other neurodegenerative diseases in which pathological alpha-synuclein deposits accumulate.
Detailed description
Primary aim (baseline):
To assess the prevalence of isolated REM Sleep Behavior Disorder (iRBD) or REM sleep without atonia (RSWA) in patients with idiopathic polyneuropathy with as to without abnormal cardiac 123I-metaiodobenzylguanidine (MIBG) scintigraphy (assessment of cardiac sympathetic innervation)
Secondary aim (baseline):
To assess the prevalence of Parkinson's Disease (PD), Dementia with Lewy bodies (DLB) and Multiple System Atrophy (MSA) in patients with idiopathic polyneuropathy.
Hypothesis (baseline):
iRBD is more prevalent in patients known with idiopathic polyneuropathy and abnormal sympathetic innervation of the heart (assessed by cardiac 123I-MIBG scintigraphy) as compared to normal cardiac sympathetic innervation.
Primary aim (5-follow-up):
To assess whether patients with idiopathic polyneuropathy develop RSWA, iRBD, PD, DLB or MSA over a periode of five years.
Hypothesis (5-follow-up):
Patients known with idiopathic polyneuropathy and abnormal sympathetic innervation of the heart (assessed by cardiac 123I-MIBG scintigraphy) will convert to RSWA, iRBD, PD, DLB or MSA more often than those with normal cardiac sympathetic innervation.
Methods:
Clinical evaluation in combination with questionnaires, multi-modal imaging methods and polysomnography.
(Assessment of neuropathy: Neuropathy Impairment Score - Lower Leg (NIS-LL), Utah Early Neurological Scale (UENS), Kumamoto Neurological Scale and autonomic function test including Tilt table Test, Valsalva Maneuver, Deep Breathing Test, The Quantitative sensory axon reflex test (QSART). Cognition: The Montreal Cognitive Assessment (MoCA), Trail making Test B (TMT-B). Motor function: MDS-Unified Parkinson's Disease Rating Scale part III (MDS-UPDRS-III). Multi-modal imaging: cardiac 123I-MIBG scintigraphy, PE2I-PET-CT, MR-neuromelanin. Sleep: REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ), one-night video polysomnography (PSG).)
Statistics:
The researchers expect to enroll 100 participants with idiopathic polyneuropathy and orthostatic hypotension or abnormal 24-hour blood pressure measurement (non-nocturnal blood pressure dip) who have undergone cardiac 123I-MIBG scintigraphy. Based on preliminary results, the investigators expect that 1/3 (30 participants) will have abnormal cardiac MIBG scintigraphy (cases; suggested to have prodromal PD or DLB) and 2/3 (70 participants) with normal MIBG scintigraphy (controls). The prevalence of iRBD detected by video-PSG is assumed to be 5% in participants with normal cardiac MIBG scintigraphy and 35% in participants with abnormal MIBG scintigraphy. To achieve a power of 88%, 81 participants have to be included (54 with normal and 27 with abnormal cardiac MIBG scintigraphy). Power calculation was based on Fisher's exact-test. Fisher's exact test was used because of an expected small number of participants with video PSG-detected iRBD.
Biobank:
Simultaneously collection of body tissue/fluids: skin, blood, cerebrospinal fluid and faeces. Analysis of the levels of phosphorylated tau, total-tau and amyloid beta in cerebrospinal fluid is performed at baseline.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Idiopathic polyneuropathy with abnormal cardiac 123I-MIBG scintigraphy | – | –Participants diagnosed with polyneuropathy, orthostatic hypotension or non-nocturnal blood pressure dip and abnormal cardiac 123I-MIBG scintigraphy (cardiac sympathetic dysfunction) |
| Idiopathic polyneuropathy with normal cardiac 123I-MIBG scintigraphy | – | –Participants diagnosed with polyneuropathy, orthostatic hypotension or non-nocturnal blood pressure dip and normal cardiac 123I-MIBG scintigraphy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with definite polyneuropathy (confirmed by nerve conductions study) diagnosed in Jutland, Denmark and orthostatic hypotension or non-nocturnal blood pressure reduction.
Key inclusion criteria (1 listed)
- Definite polyneuropathy without known etiology (idiopathic) AND orthostatic hypotension (active stand test) OR non-nocturnal blood pressure reduction (24 hour blood pressure measurement)
Key exclusion criteria (2 listed)
- Known etiology of polyneuropathy
- A diagnosis of either dementia, Parkinson's disease, Dementia with Lewy Bodies or Multiple System Atrophy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with REM sleep behavior disorder (RBD)
Time frame: RBD-status is assessed at two time point: Baseline (at the time of enrollment) and 5-year follow-up
RBD-status will be assessed by one-night video-polysomnography and REM Sleep Behavior Disorder Screening questionnaire (RBDSQ). Diagnosis of RBD according to American Academy of Sleep Medicine (AASM) criteria.
1 secondary outcome
Number of participants with Parkinson's Disease (PD) or related alpha-synucleinopathies (Dementia with Lewy bodies (DLB), Multiple System atrophy (MSA)), REM-Sleep without atonia (RSWA)
Time frame: Assessed at baseline (at the time of enrollment) and at 5-year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Astrid J. Terkelsen, MD, DrMedSc, PhD, Professor principal investigator
Department of clinical medicine, Aarhus University and Department of Neurology, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polyneuropathy and Alpha-Synucleinopathy, run by University of Aarhus at 1 site in Denmark.
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 1 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of participants with REM sleep behavior disorder (RBD) (time frame: RBD-status is assessed at two time point: Baseline (at the time of enrollment) and 5-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2025.