Evaluation of Clinical Progression in Patients With Motor Predominant Parkinson Disease.
- Conditions
- Parkinson Disease
- Registration Number
- NCT03960242
- Lead Sponsor
- BrainEver
- Brief Summary
The objective of this study is the longitudinal prospective clinical evaluation in patients with motor predominant PD; it will assess the individual disease progression (change) of the clinical and imaging parameters measured at 6-month interval over a minimum of 12 months.
- Detailed Description
The absence of clear PD subtypes defining a common path and rate of disease progression, combined with the absence of validated biomarkers indicative of disease progression and a strong placebo effect, constitute a challenge for clinical trials assessing new potential disease-modifying therapies in PD.
The present cohort would constitute a well-defined population of patients, with individual progression assessment, suitable to evaluate new disease-modifying therapies in a subsequent Phase1/2 clinical trial.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
- Idiopathic Parkinson's Disease (According to British Brain Bank Criteria); genetic forms of PD are not excluded
- Male or female adult, aged 70 or less
- Modified Hoehn and Yahr stage 2 to 3 in OFF state
- Disease duration, i.e. time from first motor symptoms between 2 to 8 (included) years ; first motor symptoms to be taken into consideration being the cardinal motor symptoms of PD (bradykinesia, tremor and rigidity)
- Univoqual response to L-DOPA (of at least 50% in MDS-UPDRS Part III motor score)
- Presence of fluctuations and/or dyskinesia
- MDS-UPDRS total motor score ≥15 in OFF state
- L-Dopa treatment stable for at least 4 weeks
- Covered by healthcare insurance
- Written informed consent form signed
- Scan Without Evidence of Dopamine Deficit (SWEDD) (DaTSCAN)
- Atypical parkinsonism syndrome
- Dementia as detected by a score < 21/30 at the Montreal Cognitive Assessment Screening (MoCA)
- Psychiatric disorders including major depression with suicidal thoughts as evaluated by a psychiatrist or a neurologist at the selection period
- Any medical or psychological problems which may interfere with a smooth conduction of the study protocol (e.g. cancer with a limited life expectancy)
- History of significant brain or vascular disease (tumor, epilepsy, stroke ...)
- Any contraindication for undergoing MRI of the head
- Prior brain surgical procedures with or without implementation of an intra-cerebral device
- Drug or alcohol addiction
- Pregnancy or breastfeeding
- Patient with reproductive potential who do not agree to use an accepted effective method of contraception - investigator's judgment- during the study period
- Illiteracy or insufficient language skills (French) to complete the questionnaires
- Patient deprived of liberty by a judicial or administrative decision, or who is under a measure of legal protection (e.g. guardianship or curatorship).
- Simultaneous participation in another clinical trial with the administration of investigational drug(s)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS Part III) "off" medications baseline, 6, 12, 18, 24 and 30 months after baseline ] An examiner will measure MDS-UPDRS part 3 motor scores "off" medications. MDS-UPDRS Part III is a motor examination consisting of 18 summed items where the investigator rates each motor symptom based on a scale of 0 - 4, higher values indicating worse function.
- Secondary Outcome Measures
Name Time Method Change from Baseline of brain MRI 12 and 24 months neuromelanin sequence
Trial Locations
- Locations (2)
Hôpital Henri Mondor
🇫🇷Créteil, France
Hôpital Pitié-Salpétrière
🇫🇷Paris, France