Effect of Donepezil on Cognition in Parkinson's Disease With Mild Cognitive Impairment (PD-MCI)
Primary Purpose
Parkinson's Disease
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Donepezil
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility Criteria
Inclusion Criteria:
- Age more than 40 years old
- Clinical diagnosis of PD established by Queen Square Brain Bank Criteria
- Stable dose of levodopa at least 3 months before the study enrollment
- Diagnosis of MCI in PD according to the Movement Disorder Society (MDS) task force guideline
Exclusion Criteria:
- Diagnosis of Dementia
- Hypersensitivity to piperidine derivatives
- Concomitant anticholinergics and cholinergic agents
- Severe cardiac arrhythmia: Sick sinus syndrome, complete AV block, Uncontrolled arrhythmia, history of ventricular fibrillation
Sites / Locations
- Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Donepezil group
control group
Arm Description
Donepezil is started in 5mg for 8 weeks followed by dose escalation to 10mg and then maintained for 40 weeks. Participants who are not tolerable to dose of 10mg due to any issues of adverse effects would be maintained with donepezil 5mg exclusively in remained period.
No administration of any therapeutic medications for dementia including cholinesterase inhibitor or NMDA receptor blocking agents. Standard treatment protocol of Parkinson's disease with mild cognitive impairment would be fulfilled including dopaminergic or nondopaminergic medications as well as nootropic drugs.
Outcomes
Primary Outcome Measures
Rate of cognitive decline
Korean Version of Mini-Mental State Exam
Secondary Outcome Measures
changes of cognitive decline
changes of Parkinson's disease motor scale
UPDRS part I-IV
Brain structure (cortical thickness and subcortical volume/shape) and Default mode network
Conventional and functional brian MRI
brain functional connectivity
digital electroencephalography
Comprehensive neuropsychological test
Seoul Neuropsychological Screening Battery (SNSB)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02450786
Brief Title
Effect of Donepezil on Cognition in Parkinson's Disease With Mild Cognitive Impairment (PD-MCI)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
There have been growing interest in identifying Parkinson's disease (PD) patients with mild cognitive impairment (MCI) which is susceptible to progress to PD dementia(PDD). PD-MCI is known to significantly correlates with low cerebrospinal beta-amyloid 1-42 and 1-40 levels, in which suggest the existence of something common with Alzheimer's dementia. PDD have showed more cholinergic deficits than Alzheimer's dementia and responds to donepezil. The investigators assume that PD-MCI patients also have cholinergic deficits. Donepezil improves cognition, and seems to be well tolerated and not to worsen parkinsonism in patients with cognitive impairment. Donepezil produced similar improvements in cognition and behaviour in DLB and PDD. This supports the hypothesis that the two disorders are closely related clinically and neurobiologically. Larger scale, placebo controlled clinical trials are needed to provide an evidence base to guide the clinical use of cholinesterase inhibitors in Lewy body disease.
It is believed that earlier intervention, later appearance of dementia should be needed to lower the socioeconomic costs and to improve the quality of life on patients and caregivers. The investigators anticipate that donepezil may delay the development of dementia in patients with PD-MCI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Donepezil group
Arm Type
Experimental
Arm Description
Donepezil is started in 5mg for 8 weeks followed by dose escalation to 10mg and then maintained for 40 weeks. Participants who are not tolerable to dose of 10mg due to any issues of adverse effects would be maintained with donepezil 5mg exclusively in remained period.
Arm Title
control group
Arm Type
No Intervention
Arm Description
No administration of any therapeutic medications for dementia including cholinesterase inhibitor or NMDA receptor blocking agents. Standard treatment protocol of Parkinson's disease with mild cognitive impairment would be fulfilled including dopaminergic or nondopaminergic medications as well as nootropic drugs.
Intervention Type
Drug
Intervention Name(s)
Donepezil
Intervention Description
Donepezil is started in patients with Parkinson's disease mild cognitive impairment with 5mg for 8 weeks followed by dose up to 10mg and then maintained for 40 weeks. Participants who are not tolerable to dose of 10mg due to any issues of adverse effects would be maintained with donepezil 5mg exclusively in remained period.
Primary Outcome Measure Information:
Title
Rate of cognitive decline
Description
Korean Version of Mini-Mental State Exam
Time Frame
at 48wks
Secondary Outcome Measure Information:
Title
changes of cognitive decline
Time Frame
baseline, 24 wks, 48 wks, 72 wks
Title
changes of Parkinson's disease motor scale
Description
UPDRS part I-IV
Time Frame
baseline, 24 wks, 48 wks, 72wks
Title
Brain structure (cortical thickness and subcortical volume/shape) and Default mode network
Description
Conventional and functional brian MRI
Time Frame
48wks
Title
brain functional connectivity
Description
digital electroencephalography
Time Frame
48wks
Title
Comprehensive neuropsychological test
Description
Seoul Neuropsychological Screening Battery (SNSB)
Time Frame
48wks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age more than 40 years old
Clinical diagnosis of PD established by Queen Square Brain Bank Criteria
Stable dose of levodopa at least 3 months before the study enrollment
Diagnosis of MCI in PD according to the Movement Disorder Society (MDS) task force guideline
Exclusion Criteria:
Diagnosis of Dementia
Hypersensitivity to piperidine derivatives
Concomitant anticholinergics and cholinergic agents
Severe cardiac arrhythmia: Sick sinus syndrome, complete AV block, Uncontrolled arrhythmia, history of ventricular fibrillation
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Donepezil on Cognition in Parkinson's Disease With Mild Cognitive Impairment (PD-MCI)
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