Longitudinal Exploratory Prospective Evaluation of Clinical Evolution in Patients With Motor Predominant Parkinson Disease.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- BrainEver
- Enrollment
- 3
- Locations
- 2
- Primary Endpoint
- Change from baseline in Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS Part III) "off" medications
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change from baseline in Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS Part III) "off" medications
Time Frame: 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 Outcomes
- Change from Baseline of brain MRI(12 and 24 months)