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

August 5, 2015 updated by: Sangjin Kim, Inje University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Recruiting
        • Inje university, busan paik hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Korean Mini-Mental State Examination-2 (MMSE-2)
Time Frame: 24 weeks
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
Time Frame: 24 weeks
scales for activities daily living
24 weeks
Clinical dementia rating
Time Frame: 24 weeks
scales for activities of daily living
24 weeks
Unified Parkinson's disease rating scale (UPDRS) part 3
Time Frame: 24 weeks
scales for motor symptoms in Parkinson's disease
24 weeks
Modified Hoehn & Yahr stage
Time Frame: 24 weeks
scales for status of Parkinson's disease
24 weeks
Schwab & England Activities of Daily Living
Time Frame: 24 weeks
scales for activities daily living
24 weeks
Caregiver-Administered Neuropsychiatric Inventory
Time Frame: 24 weeks
scales for status of caregiver
24 weeks
Global Deterioration Scale
Time Frame: 24 weeks
scales for activities of daily living
24 weeks
Korean-Montreal Cognitive Assessment
Time Frame: 24 weeks
scales for cognition
24 weeks
Semantic fluency to evaluate neuropsychiatric symptoms
Time Frame: 24 weeks
scales for language
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inje University

Investigators

  • Principal Investigator: Sangjin Kim, Professor, Inje University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

March 14, 2015

First Submitted That Met QC Criteria

April 8, 2015

First Posted (Estimate)

April 14, 2015

Study Record Updates

Last Update Posted (Estimate)

August 6, 2015

Last Update Submitted That Met QC Criteria

August 5, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUPID-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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