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

NCT05384522 | Unknown

• 1 other identifier: INRCA_002_2022
• Study Type: observational
• Target: 103
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Parkinson Disease

Keywords

Parkinson disease; aging; biomarkers; DNA methylation; precision medicine; epigenomics; genetics; disease progression

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 12 months later

Secondary Outcomes (5)

• Prognostic role of genetic biomarkers with respect to the advancing of PD motor decline

  Baseline and 12 months later

• Prognostic role of bone sialoprotein (BSP) with respect to the advancing of PD motor decline

  Baseline and 12 months later

• Prognostic role of osteomodulin (OMD) with respect to the advancing of PD motor decline

  Baseline and 12 months later

• Prognostic role of aminoacylase-1 (ACY1) with respect to the advancing of PD motor decline

  Baseline and 12 months later

• Prognostic role of growth hormone receptor (GHR) with respect to the advancing of PD motor decline

  Baseline and 12 months later

Study Arms (1)

Parkinson's Disease subjects

Subjects with Parkinson Disease aged 65 years or more at Hoehn and Yahr stage ≤3

Other: blood samples collection

Interventions

blood samples collection OTHER

Blood samples will be drawn at baseline and at 6 and 12 months from baseline

Parkinson's Disease subjects

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Nazionale di Ricovero e Cura per Anziani: lead

Biospecimen

Retention: SAMPLES WITH DNA

A volume of approximately 35 mL (5ml EDTA tubes, 5ml LiHep tubes, 10 ml serum tubes, 10 ml whole blood tubes and 5 ml citrate tubes) of peripheral blood will be collected at baseline and after 6 and 12 months. The buffy coat for DNA extraction will be stored from the same tubes. Five mL of urine will be collected from all study participants at baseline and at 6 and 12 months.

MeSH Terms

Conditions

Parkinson Disease; Disease Progression

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Giuseppe Pelliccioni, MD

  IRCCS INRCA, Ancona, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Rita Bonfigli

CONTACT

+390718003719; a.bonfigli@inrca.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 20, 2022
• Study Start: May 30, 2024
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: March 5, 2024

Record last verified: 2023-10