Status:
COMPLETED
Study of Rivastigmine to Treat Parkinsonian Apathy Without Dementia
Lead Sponsor:
University Hospital, Lille
Conditions:
Parkinson's Disease
Apathy
Eligibility:
All Genders
15-80 years
Phase:
PHASE3
Brief Summary
Apathy usually refers to a set of behavioural, emotional and cognitive features as a reduced interest and participation in main activities of daily life, a lack of initiative, a trend toward an early ...
Detailed Description
Overall study duration: 2 years. Planned inclusion period: 12 months. Study duration for individual patients: 7 months (2 weeks between screening and randomization, 6 months of double-blind treatment ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Clinical diagnosis of Parkinson's disease: Gibb and Gelb criteria
- Apathy defined by a score of - 16 or more on the LARS scale (Sockeel et al., 2006)and criteria of Marin (1991)
- No dementia according to DSM IV with MMSE Score≥ 27 and Mattis score≥ 130
- Under stable dopaminergic treatment for 3 months
- Exclusion criteria:
- Depression according to DSM-IV criteria and a score \< 18 on the MADRS
- Subthalamic stimulation of less than one year
- Subthalamic stimulation without stable parameters for 3 months
- Subject older than 80 years
- Severe rest tremor with a subscore \> or= 3 on the UPDRS part
- Parkinson related Psychosis in progress
- Hypersensibility to cholinesterase inhibitors or carbamates
- Myocardial infarction, other cardiac affections
- Severe hepatic insufficiency
- Sever medical illness
- Skin diseases interfering with transdermal patch
- Pregnancy
- Incapacity to give the consent
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00767091
Start Date
March 1 2009
End Date
January 1 2012
Last Update
April 24 2012
Active Locations (1)
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1
Devos
Lille, Nord, France, 59037