The Efficacy and Safety Study of High Dose Donepezil in Parkinson's Disease With Dementia

Study Overview
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Brief Summary
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The purpose of this study to evaluate the safety and efficacy of high-dose donepezil (23mg) in Parkinson's disease with dementia compared to standard dose donepezil.

Detailed Description
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This study is open-label, prospective, randomized paralleled study. The investigators evaluate the efficacy of high-dose donepezil in patients with Parkinson's disease with dementia (PDD) who have taken standard donepezil (10mg) for 12 weeks. The participants, who sign the informed consent, are assigned into two groups randomly (high-dose donepezil group and standard donepezil group). All participants will be maintained the medication for 24 weeks and assessed cognitive function at 24 weeks. They will visit to clinic for 3 times (4, 12, 24 weeks) to assess cognitive function and adverse event. After the end of study, all participants were administrated by standard dose donepezil again.

Official Title
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The Efficacy of 23mg Versus 10mg of Donepezil in ParkInson's Disease With Dementia

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: Donepezil


Participation Criteria
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Eligibility Criteria
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Inclusion criteria : Patients diagnosed as Parkinson's disease according to Queen Brain Bank criteria Patients who have been diagnosed as dementia after diagnosing Parkinson's disease at least 1 year. Patients with Hoehn and Yahr staging from 2 to 4 Patients with MMSE score from 10 to 24 Patients who have taken donepezil for at least 12 weeks before screening period Patients whose medications for Parkinson's disease have not change for 1 month Patients who give informed consent Exclusion criteria : Patients who cannot be performed neuropsychiatric test because of hearing and visual difficulty Patients who have taken medicine affecting cognitive function such as anticholinergic drug and memantine -Patients diagnosed as dementia with Lewy body and vascular dementia- Patients who have history of neurosyphilis, head trauma, encephalitis or other movement disorders Patients who have psychiatric disease Except patients who are stable state under antidepressant or atypical neuroleptics Patients with child-bearing periods Patients who have severe liver or kidney disease necessary for aggressive treatment Patients who have gastrointestinal disease needed for treatment Patients who cannot taken tablet per oral Patients who are participated in other clinical trial except observational study

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high dose donepezil (23mg)<br>Patients with dementia in Parkinson's disease, who are treated with high dose donepezil (23mg) | Drug: Donepezil<br>* 23mg/day for 24 weeks versus 10mg/day for 24 weeks<br>* Other names: aricept;|
| Active Comparator: standard dose denepezil (10mg)<br>Patients with dementia in Parkinson's disease, who are treated with standard dose donepezil (10mg) | Drug: Donepezil<br>* 23mg/day for 24 weeks versus 10mg/day for 24 weeks<br>* Other names: aricept;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Korean Mini-Mental State Examination-2 (MMSE-2) | scale for general cognitive function, We used Korean version of MMSE-2 from PAR company | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Korean-Instrumental Activities of Daily Living | scales for activities daily living | 24 weeks | 
| Clinical dementia rating | scales for activities of daily living | 24 weeks | 
| Unified Parkinson's disease rating scale (UPDRS) part 3 | scales for motor symptoms in Parkinson's disease | 24 weeks | 
| Modified Hoehn & Yahr stage | scales for status of Parkinson's disease | 24 weeks | 
| Schwab & England Activities of Daily Living | scales for activities daily living | 24 weeks | 
| Caregiver-Administered Neuropsychiatric Inventory | scales for status of caregiver | 24 weeks | 
| Global Deterioration Scale | scales for activities of daily living | 24 weeks | 
| Korean-Montreal Cognitive Assessment | scales for cognition | 24 weeks | 
| Semantic fluency to evaluate neuropsychiatric symptoms | scales for language | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, dementia