Analysis of the Prognostic Role of Epigenetic Biomarkers in Relation to the Motor Decline in Parkinson's Disease (BioGenPark)

March 4, 2024 updated by: Istituto Nazionale di Ricovero e Cura per Anziani
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

103

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Community-dwelling subjects aged 65 years or more with Parkinson Disease at Hoehn and Yahr stage ≤3

Description

Inclusion Criteria:

  • PD at Hoehn and Yahr stage ≤3
  • MMSE test ≥24 score

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Parkinson's Disease subjects
Subjects with Parkinson Disease aged 65 years or more at Hoehn and Yahr stage ≤3
Other: blood samples collection
Blood samples will be drawn at baseline and at 6 and 12 months from baseline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 12 months later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic role of genetic 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 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.
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
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.
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
Change of Unified Parkinson's Disease Rating Scale (UPDRSIII) in relation to the levels of baseline osteomodulin (OMD).
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
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.
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
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.
Baseline and 12 months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Nazionale di Ricovero e Cura per Anziani

Investigators

  • Principal Investigator: Giuseppe Pelliccioni, MD, IRCCS INRCA, Ancona, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 30, 2024

Primary Completion (Estimated)

January 30, 2026

Study Completion (Estimated)

January 30, 2026

Study Registration Dates

First Submitted

May 17, 2022

First Submitted That Met QC Criteria

May 17, 2022

First Posted (Actual)

May 20, 2022

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INRCA_002_2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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