Parkinson DiseaseBioGenParkNCT05384522
Analysis of the Prognostic Role of Epigenetic Biomarkers in Relation to the Motor Decline in Parkinson's Disease
An observational study of Parkinson Disease, run by Istituto Nazionale di Ricovero e Cura per Anziani.
Trial summary
BioGenParkinson is an observational, prospective cohort study evaluating biomarkers of Parkinson's Disease (PD) progression in community-dwelling subjects aged 65 years or more, consecutively referring to INRCA outpatient clinic of the Neurology Unit. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- blood samples collection
- How many people
- 103 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2024to 30 Jan 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 65 years and older
- All sexes
- Older adult
Study population: Community-dwelling subjects aged 65 years or more with Parkinson Disease at Hoehn and Yahr stage ≤3
Who may be able to join
- PD at Hoehn and Yahr stage ≤3
- MMSE test ≥24 score
Who cannot join
- MMSE score < 24
- Severe cardiovascular diseases (including congestive heart failure NYHA=4, acute coronary syndrome, stroke)
- History of traumatic brain injury, previous deep brain surgery
- Current substance or alcohol abuse
- Reduced life expectancy less than six months
Trial locations and contacts
No sites are listed yet.
About this study
BioGenParkinson is an observational, prospective cohort study evaluating biomarkers of Parkinson's Disease (PD) progression in community-dwelling subjects aged 65 years or more, consecutively referring to INRCA outpatient clinic of the Neurology Unit. Selected patients will undergo clinical and laboratory evaluations at the baseline, and will be followed up after 6 and 12 months. The biological evaluation will include the determination of i) routine biological parameters ii) advanced biomarkers such as epigenetic analysis of DNA methylation, genetic analysis on multiple loci associated with PD progression and specific proteins associated with motor and non-motor decline. After obtaining all data, multiple statistical analysis will be performed to evaluate the most accurate prognostic biomarkers of PD progression at this stage of disease.
Read the detailed description
The objective of the BioGenParkinson study is the evaluation of the prognostic accuracy of epigenetic, genetic and protein biomarkers in relation to Parkinson's Disease (PD) motor symptoms progression (assessed by changes in Unified Parkinson's Disease Rating Scale Part III (UPDRS III)) in biological samples of 103 PD patients aged 65 or more. Changes of quality of life (assessed by Parkinson's Disease Questionnaire 39 item (PDQ-39)) and cognitive performance (assessed by the Mini-Mental State Examination (MMSE)) will be also investigated. The characterization of the PD patients' phenotypes and genotypes will allow the investigation on the predisposition to a severe progression of the disease, in order to early predict the progression of the disease and improving the accuracy of personalized interventions. The evidence collected will inform multidisciplinary and personalized interventions in the future.
Among the advanced biomarkers that will be evaluated in the Study, epigenetic analysis of CpG loci such as cg17445913 in KCNB1 gene, cg02920897 in DLEU2 gene and cg01754178 in PTPRN2 gene are expected to improve the prognostic accuracy of motor and cognitive decline of PD patients at Hoehn and Yahr stage II/III after 12 months of follow up. Genetic analysis in purified genomic DNA samples will be performed on multiple loci associated with PD progression such as rs2230288 and rs75548401 in order to confirm their association with motor decline over time, and to assess their association with non-motor decline.
Protein analysis on bone sialoprotein (BSP), osteomodulin (OMD), aminoacylase-1 (ACY1), and growth hormone receptor (GHR) will be also evaluated with respect to motor and non-motor decline in PD patients in order to be compared with the other biomarkers. Scores on UPDRS Parts III, obtained by using using the published cut-offs classification of MDS-UPDRS severity, will be drawn at the baseline, at 6-month and at 12-month follow-up visits, in order to assess PD motor progression. Additional assessments include demographic and clinical data, Parkinson Disease Questionnaire 39 item (PDQ-39) Hoehn and Yahr stage, MMSE, Frontal Assessment Battery (FAB), list of disease and medication, falls, functional status, quality of life and socio-economic characteristics.
- Conditions
- Parkinson Disease
- Being tested
- blood samples collection
- Keywords
- Parkinson disease, aging, biomarkers, DNA methylation, precision medicine, epigenomics, genetics, disease progression
- Medical subject headings
- Parkinson Disease, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samples collectionOther
Blood samples will be drawn at baseline and at 6 and 12 months from baseline
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Disease subjects | Subjects with Parkinson Disease aged 65 years or more at Hoehn and Yahr stage ≤3 Receives: Other: blood samples collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic role of epigenetic biomarkers with respect to the advancing of PD motor decline
Change of Unified Parkinson's Disease Rating Scale (UPDRSIII) in relation to the baseline methylation status of the following epigenetic biomarkers: CpG loci cg17445913, cg02920897 and cg01754178. PD motor decline will be defined by an increase of UPDRS III at least of 2.4 points/year.
Measured: Baseline and 12 months later
Secondary outcomes (5)
Prognostic role of genetic biomarkers with respect to the advancing of PD motor decline
Change of Unified Parkinson's Disease Rating Scale (UPDRSIII) in relation to the presence of mutations of the GBA coding variants rs2230288 and rs75548401. PD motor decline will be defined by an increase of UPDRS III at least of 2.4 points/year.
Measured: Baseline and 12 months later
Prognostic role of bone sialoprotein (BSP) with respect to the advancing of PD motor decline
Change of Unified Parkinson's Disease Rating Scale (UPDRSIII) in relation to the levels of baseline bone sialoprotein (BSP). PD motor decline will be defined by an increase of UPDRS III at least of 2.4 points/year.
Measured: Baseline and 12 months later
Prognostic role of osteomodulin (OMD) with respect to the advancing of PD motor decline
Change of Unified Parkinson's Disease Rating Scale (UPDRSIII) in relation to the levels of baseline osteomodulin (OMD).
Measured: Baseline and 12 months later
Prognostic role of aminoacylase-1 (ACY1) with respect to the advancing of PD motor decline
Change of Unified Parkinson's Disease Rating Scale (UPDRSIII) in relation to the levels of baseline aminoacylase-1 (ACY1).PD motor decline will be defined by an increase of UPDRS III at least of 2.4 points/year.
Measured: Baseline and 12 months later
Prognostic role of growth hormone receptor (GHR) with respect to the advancing of PD motor decline
Change of Unified Parkinson's Disease Rating Scale (UPDRSIII) in relation to the levels of baseline growth hormone receptor (GHR).PD motor decline will be defined by an increase of UPDRS III at least of 2.4 points/year.
Measured: Baseline and 12 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start30 May 2024 (estimated)
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Pelliccioni, MD, Principal investigator, IRCCS INRCA, Ancona, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384522
- Sponsor's protocol ID
- INRCA_002_2022
- Acronym
- BioGenPark
- Status last verified
- Oct 2023
- First submitted
- 17 May 2022
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Prognostic Role of Epigenetic Biomarkers in Relation to the Motor Decline in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05384522
- Acronym / sponsor ID
- BioGenPark / INRCA_002_2022
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, aging, biomarkers, DNA methylation, precision medicine, epigenomics, genetics, disease progression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Study start
- 30 May 2024 (estimated)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 20 May 2022 (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.
BioGenParkinson is an observational, prospective cohort study evaluating biomarkers of Parkinson's Disease (PD) progression in community-dwelling subjects aged 65 years or more, consecutively referring to INRCA outpatient clinic of the Neurology Unit. Selected patients will undergo clinical and laboratory evaluations at the baseline, and will be followed up after 6 and 12 months. The biological evaluation will include the determination of i) routine biological parameters ii) advanced biomarkers such as epigenetic analysis of DNA methylation, genetic analysis on multiple loci associated with PD progression and specific proteins associated with motor and non-motor decline. After obtaining all data, multiple statistical analysis will be performed to evaluate the most accurate prognostic biomarkers of PD progression at this stage of disease.
Detailed description
The objective of the BioGenParkinson study is the evaluation of the prognostic accuracy of epigenetic, genetic and protein biomarkers in relation to Parkinson's Disease (PD) motor symptoms progression (assessed by changes in Unified Parkinson's Disease Rating Scale Part III (UPDRS III)) in biological samples of 103 PD patients aged 65 or more. Changes of quality of life (assessed by Parkinson's Disease Questionnaire 39 item (PDQ-39)) and cognitive performance (assessed by the Mini-Mental State Examination (MMSE)) will be also investigated. The characterization of the PD patients' phenotypes and genotypes will allow the investigation on the predisposition to a severe progression of the disease, in order to early predict the progression of the disease and improving the accuracy of personalized interventions. The evidence collected will inform multidisciplinary and personalized interventions in the future.
Among the advanced biomarkers that will be evaluated in the Study, epigenetic analysis of CpG loci such as cg17445913 in KCNB1 gene, cg02920897 in DLEU2 gene and cg01754178 in PTPRN2 gene are expected to improve the prognostic accuracy of motor and cognitive decline of PD patients at Hoehn and Yahr stage II/III after 12 months of follow up. Genetic analysis in purified genomic DNA samples will be performed on multiple loci associated with PD progression such as rs2230288 and rs75548401 in order to confirm their association with motor decline over time, and to assess their association with non-motor decline.
Protein analysis on bone sialoprotein (BSP), osteomodulin (OMD), aminoacylase-1 (ACY1), and growth hormone receptor (GHR) will be also evaluated with respect to motor and non-motor decline in PD patients in order to be compared with the other biomarkers. Scores on UPDRS Parts III, obtained by using using the published cut-offs classification of MDS-UPDRS severity, will be drawn at the baseline, at 6-month and at 12-month follow-up visits, in order to assess PD motor progression. Additional assessments include demographic and clinical data, Parkinson Disease Questionnaire 39 item (PDQ-39) Hoehn and Yahr stage, MMSE, Frontal Assessment Battery (FAB), list of disease and medication, falls, functional status, quality of life and socio-economic characteristics.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease subjects | – | Other: blood samples collectionSubjects with Parkinson Disease aged 65 years or more at Hoehn and Yahr stage ≤3 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Community-dwelling subjects aged 65 years or more with Parkinson Disease at Hoehn and Yahr stage ≤3
Key inclusion criteria (2 listed)
- PD at Hoehn and Yahr stage ≤3
- MMSE test ≥24 score
Key exclusion criteria (5 listed)
- MMSE score < 24
- Severe cardiovascular diseases (including congestive heart failure NYHA=4, acute coronary syndrome, stroke)
- History of traumatic brain injury, previous deep brain surgery
- Current substance or alcohol abuse
- Reduced life expectancy less than six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samples collectionBlood samples will be drawn at baseline and at 6 and 12 months from baseline | Other | Parkinson's Disease subjects |
Primary outcome
Prognostic role of epigenetic biomarkers with respect to the advancing of PD motor decline
Time frame: Baseline and 12 months later
Change of Unified Parkinson's Disease Rating Scale (UPDRSIII) in relation to the baseline methylation status of the following epigenetic biomarkers: CpG loci cg17445913, cg02920897 and cg01754178. PD motor decline will be defined by an increase of UPDRS III at least of 2.4 points/year.
5 secondary outcomes
Prognostic role of genetic biomarkers with respect to the advancing of PD motor decline
Time frame: Baseline and 12 months later
Prognostic role of bone sialoprotein (BSP) with respect to the advancing of PD motor decline
Time frame: Baseline and 12 months later
Prognostic role of osteomodulin (OMD) with respect to the advancing of PD motor decline
Time frame: Baseline and 12 months later
Prognostic role of aminoacylase-1 (ACY1) with respect to the advancing of PD motor decline
Time frame: Baseline and 12 months later
Prognostic role of growth hormone receptor (GHR) with respect to the advancing of PD motor decline
Time frame: Baseline and 12 months later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
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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. This study is not recruiting at the moment.
Giuseppe Pelliccioni, MD principal investigator
IRCCS INRCA, Ancona, Italy
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Istituto Nazionale di Ricovero e Cura per Anziani.
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 2 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 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Anna Rita Bonfigli (+390718003719, a.bonfigli@inrca.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic role of epigenetic biomarkers with respect to the advancing of PD motor decline (time frame: Baseline and 12 months later). 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 5 Mar 2024.