Etude d’efficacité et d’acceptabilité d’un traitement cholinergique dans l’apathie parkinsonienne “Cholinergic treatment in Parkinsonian Apathy: ChoPA - I” - ChoPA-I

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-002578-36-FR

Enrollment

Registered

2008-07-21

Start date

2008-09-10

Completion date

Unknown

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinsonian Apathy without dementia and depression in spite of dopaminergic treatment

Interventions

Trade Name: Exelon patch Pharmaceutical Form: Transdermal patch Pharmaceutical form of the placebo: Transdermal patch Route of administration of the placebo: Transdermal use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Parkinson dieases since 5 years Apathy MMSE score =27 Matis score =130 No dementia and depression (defined by the DSM-IV) MADRS score =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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 . Neurological tolerance (behaviour and motor ) and general tolerance . ;Primary end point(s): LARS: the Lille Apathy Rating Scale	—

Measure

Time frame

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 . Neurological tolerance (behaviour and motor ) and general tolerance . ;Primary end point(s): LARS: the Lille Apathy Rating Scale

—

Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026