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

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. Identifier: NCT02415062
Recruitment Status : Unknown
Verified August 2015 by Sangjin Kim, Inje University.
Recruitment status was:  Recruiting
First Posted : April 14, 2015
Last Update Posted : August 6, 2015
Information provided by (Responsible Party):
Sangjin Kim, 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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Donepezil Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of 23mg Versus 10mg of Donepezil in ParkInson's Disease With Dementia
Study Start Date : July 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

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 Name: 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 Name: aricept

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Korean-Instrumental Activities of Daily Living [ Time Frame: 24 weeks ]
    scales for activities daily living

  2. Clinical dementia rating [ Time Frame: 24 weeks ]
    scales for activities of daily living

  3. Unified Parkinson's disease rating scale (UPDRS) part 3 [ Time Frame: 24 weeks ]
    scales for motor symptoms in Parkinson's disease

  4. Modified Hoehn & Yahr stage [ Time Frame: 24 weeks ]
    scales for status of Parkinson's disease

  5. Schwab & England Activities of Daily Living [ Time Frame: 24 weeks ]
    scales for activities daily living

  6. Caregiver-Administered Neuropsychiatric Inventory [ Time Frame: 24 weeks ]
    scales for status of caregiver

  7. Global Deterioration Scale [ Time Frame: 24 weeks ]
    scales for activities of daily living

  8. Korean-Montreal Cognitive Assessment [ Time Frame: 24 weeks ]
    scales for cognition

  9. Semantic fluency to evaluate neuropsychiatric symptoms [ Time Frame: 24 weeks ]
    scales for language

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT02415062

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Contact: Sangjin Kim, Professor 82-51-797-8736

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Korea, Republic of
Inje university, busan paik hospital Recruiting
Busan, Korea, Republic of
Contact: Sang-jin kim, professor    82-10-9525-6207   
Sponsors and Collaborators
Inje University
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Principal Investigator: Sangjin Kim, Professor Inje University
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Responsible Party: Sangjin Kim, Busan Paik Hospital, Inje University, Inje University Identifier: NCT02415062    
Other Study ID Numbers: CUPID-01
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: August 6, 2015
Last Verified: August 2015
Keywords provided by Sangjin Kim, Inje University:
Parkinson's disease
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents