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

Phase 2

• Conditions: Parkinson's Disease
• Interventions: Drug: Donepezil

• Registration Number: NCT02415062
• Lead Sponsor: Inje University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-03-14
• Study First Submitted QC: 2015-04-08
• Study First Posted: 2015-04-14
• Study Start: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-05
• Last Update Posted: 2015-08-06
• Primary Completion: 2016-10
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard dose denepezil (10mg)	Donepezil	Patients with dementia in Parkinson's disease, who are treated with standard dose donepezil (10mg)
high dose donepezil (23mg)	Donepezil	Patients with dementia in Parkinson's disease, who are treated with high dose donepezil (23mg)

Primary Outcome Measures

Name	Time	Method
Korean Mini-Mental State Examination-2 (MMSE-2)	24 weeks	scale for general cognitive function, We used Korean version of MMSE-2 from PAR company

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Inje university, busan paik hospital; 🇰🇷 Busan, Korea, Republic of