Etude d’efficacité et d’acceptabilité d’un traitement cholinergique dans l’apathie parkinsonienne Cholinergic treatment in Parkinsonian Apathy: ChoPA - I” - ChoPA-I
- Conditions
- Parkinsonian Apathy without dementia and depression in spite of dopaminergic treatment
- Registration Number
- EUCTR2008-002578-36-FR
- Lead Sponsor
- CHRU de LILLE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 29
Parkinson dieases since 5 years
Apathy
MMSE score =27
Matis score =130
No dementia and depression (defined by the DSM-IV)
MADRS score < 18
IF subthalamic stimulation there are more critria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
more 80 years old
dopaminergic treatment
Treatment by High frequency stimulation of subthalamic nuclei
resting tremor very severe and uncontrolled
psychosis dopaminergic
Hypersensitivity to cholinesterase ihnibitor
Important cardivascular disorder
hepatic insufficiency
Evolutionary gastro-duodenal ulcer
undernutrited
Grave pathology
pregnancy and feeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Efficacity of Cholinergic treatment in Parkinsonian Apathy assessed by the LARS ( Lille Apathy Rating Scale ) ;Secondary Objective: Efficacity of Cholinergic treatment on others behaviour disorders, daytime somnolence, quality of sleep and measure on peack of choline and glutamate at the level of some structure implicated in Parkinsonian Apathy .<br>Neurological tolerance (behaviour and motor ) and general tolerance . ;Primary end point(s): LARS: the Lille Apathy Rating Scale
- Secondary Outcome Measures
Name Time Method