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Study of Rivastigmine to Treat Parkinsonian Apathy Without Dementia (CHoPA-I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00767091
Recruitment Status : Completed
First Posted : October 6, 2008
Last Update Posted : April 24, 2012
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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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 withdrawal from started activities, an indifference and a flattening of affect. We have validated a new specific scale (Lille Apathy Rating Scale, LARS) in order to detect and quantify apathy in Parkinson's disease (PD). Apathy was shown to be frequent in PD with a prevalence of 32%. It has suggested that the medial frontal and limbic cholinergic deficits may underlie apathy in neurodegenerative disorders like Alzheimer's disease (AD). Such a hypothesis is supported by recent evidence indicating the beneficial effects of cholinesterase inhibitors on neuropsychiatric symptoms, mainly apathy, in AD patients. As the efficacy of rivastigmine on cognition has also been shown in PD, we aimed to assess with a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial, the efficacy and acceptability of a 6 months treatment with rivastigmine on apathy in 60 patients with PD without dementia. The primary end point will be the LARS score and the secondary end points will be the cognitive, behavioural and motor symptoms of PD. Two add-on studies will be proposed: first the measure of choline and glutamate peaks on Magnetic Resonance Spectrometry focused on the structures implicated in apathy in order to give insights in the physiopathological mechanisms of the treatment. Secondly, the recording of the REM sleep behavior disorders in relation with the cholinergic part of the pedunculopontine nucleus. Regarding that apathy could be one of the first steps toward PD dementia, treating very early could have substantial implications on the patients and their caregiver.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Apathy no Dementia Drug: rivastigmine Drug: placebo Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicentric Trial
Study Start Date : March 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Active treatment
A: transdermal rivastigmine at 4.6 mg per day during one month then 9.5 mg per day during 5 months.
 Drug: rivastigmine
transdermal patch of rivastigmine of 9.5 mg/day
Other Name: cholinesterase inhibitors (Exelon)
Placebo Comparator: placebo
transdermal patch of placebo
 Drug: placebo
transdermal patch of placebo
Other Name: transdermal patch without active substance


Outcome Measures
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Primary Outcome Measures :
  1. Measure on the scale : Lille Apathy Rating Scale (LARS) [ Time Frame: 6 months ]
    measure of the reduction of apathy with this qualitative scale from -36 +36 with the cut off -16


Secondary Outcome Measures :
  1. Cognitive, motor and behaviour assessment [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00767091


Locations
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France
Devos
Lille, Nord, France, 59037
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: David Devos, MD, PhD Department of Neurology, University Hospital, Lille
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT00767091    
Other Study ID Numbers: 2008-002578-36
2008/0817 ( Other Identifier: sponsor )
First Posted: October 6, 2008    Key Record Dates
Last Update Posted: April 24, 2012
Last Verified: March 2009
Keywords provided by University Hospital, Lille:
Parkinson's disease
Apathy
Rivastigmine
 transdermal patch
anticholinesterasic
acetylcholine
Additional relevant MeSH terms:
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Parkinson Disease
Dementia
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Neurocognitive Disorders
 Mental Disorders
Rivastigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents