Ireland
--:--IST
Active, not recruiting Observational

Cohort Study to Identify Predictor Factors of Onset and Progression of Parkinson's Disease

NCT02305147 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2014-11-06
Last updated
2026-07-08

Condition(s) studied

Parkinson Disease

Investigational drug(s) / intervention(s)

Clinical, biological and imaging followup

Clinical, biological and imaging followup: Assessment of motor and non motor signs every 12 months. Imaging and blood, cerebral fluid, stools and skin samples for identification of biomarkers of disease phenotype and progression.

Study summary

Observational, prospective, monocentric study to assess clinical features, imaging and biologic biomarkers in Parkinson disease (PD) patients and rate of progression compared to healthy controls (HC) and subjects at risk to develop PD.

The primary objective of this study is to identify clinical, imaging and biologic markers of PD onset and progression for use in clinical trials of disease-modifying therapies.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * All subjects: Male or female age 18 years and older, MMSE score \> 26, negative pregnancy test in potentially child-bearing women (contraindication to SPECT with DatScan). * Idiopathic Parkinson disease subjects: diagnosis confirmed according to UK Parkinson's Disease Society Brain Bank criteria (UKPDSBB); disease duration less than 3 years. * Genetic Parkinson disease subjects: parkinson diagnosis confirmed and mutation in parkin, LRRK2, SNCA or GBA genes. * Prodromal subjects: subjects with identified relative with PD genetically confirmed or subjects with diagnosis of idiopathic Rem sleep Behavior Disorder (iRBD); neurological examination normal (no signs of parkinsonism). * Healthy subjects: neurological examination normal Exclusion Criteria: * All subjects: Psychiatric disorder or any progressive life-threatening disease, impairment precluding appropriate information and instructions given concerning participation to the study; contra-indication to MRI or SPECT scan. * Parkinson disease subjects: no dopamine transporter deficit at SPECT scan; parkinsonism induced by neuroleptics; neuroleptics intake within 6 months; atypical parkinson syndrom (MSA, PSP, CBD...) * Parkinson disease subjects with mutation in Parkin, LRRK2, SNCA or GBA gene: atypical parkinson disease syndromes due to either drugs (e.g., metoclopramide, flunarizine, neuroleptics) or metabolic disorders (e.g., Wilson's disease), encephalitis or degenerative diseases (e.g., progressive supranuclear palsy) or currently taking neuroleptics or has taken neuroleptics within 6 months of baseline or any biological anomaly.

Primary outcome measure(s)

  • Rates of change of clinical, imaging and biomic outcomes — 4 years (annual visits)
    Slopes of change of clinical, imaging and biomics compared between PD patients, subjects at risk to develop PD and healthy subjects. Identification of predictive factors of these rates of change. As examples, outcomes include: MDS-UPDRS, Mattis dementia rating scale, Non Motor Signs scale, DAT striatal uptake.

Trial sites (1)

FacilityCityRegionStatus
Hôpital Pitié-Salpêtrière Paris France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02305147 on ClinicalTrials.gov ↗ ← All trials in France