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

NCT02305147 | Recruiting

• 1 other identifier: C13-74
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Biomarkers; Prognostic factors; Prodromal features; Disease progression

Outcome Measures

Primary Outcomes (1)

• Rates of change of clinical, imaging and biomic outcomes

  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.

  4 years (annual visits)

Secondary Outcomes (3)

• Clinical milestones in PD patients

  4 years (annual visits)

• Prodromal features in subjects at risk to develop PD

  4 years (annual visits)

• Phenoconversion in subjects at risk to develop PD

  4 years (annual visits)

Study Arms (4)

Patients with an idiopathic Parkinson Disease,

Patients with recent onset of Parkinson Disease: N=200

Subjects at risk of PD

Subjects at risk to develop Parkinson Disease: * subjects with idiopathic Rem-sleep behavior disorder (iRBD): N=50 * subjects related to a patient with genetically confirmed Parkinson Disease: N=30

Other: Clinical, biological and imaging followup

Controls

Healthy controls: N=50

Other: Clinical, biological and imaging followup

Patients with Parkinson Disease with genetic mutation

Patients with Parkinson Disease with a genetic mutation in parkin, LRRK2, SNCA or GBA (N=30)

Interventions

Clinical, biological and imaging followup OTHER

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.

Controls; Subjects at risk of PD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with recent onset of Parkinson Disease (less than 3 years since diagnosis) compared to subjects at risk to develop Parkinson Disease and healthy controls

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead
• IHU-A-ICM, Paris, France: collaborator

Study Sites (1)

Hôpital Pitié-Salpêtrière

Paris, 75013, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Sampling at baseline

MeSH Terms

Conditions

Parkinson Disease; Disease Progression

Interventions

Biological Products

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

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

• Marie VIDAILHET, PhD

  Assistance Publique - Hôpitaux de Paris, FRANCE

  PRINCIPAL INVESTIGATOR

• Jean-Christophe CORVOL, PhD

  Assistance Publique - Hôpitaux de Paris, FRANCE

  STUDY CHAIR

Central Study Contacts

Marie VIDAILHET, PhD

CONTACT

marie.vidailhet@psl.aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2014
• First Posted: December 2, 2014
• Study Start: November 6, 2014
• Primary Completion (Estimated): November 6, 2029
• Study Completion (Estimated): November 6, 2029
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

FR (1)