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

Primary Purpose

Parkinson's Disease

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Donepezil
Sponsored by
Inje University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, dementia

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Inje university, busan paik hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

high dose donepezil (23mg)

standard dose denepezil (10mg)

Arm Description

Patients with dementia in Parkinson's disease, who are treated with high dose donepezil (23mg)

Patients with dementia in Parkinson's disease, who are treated with standard dose donepezil (10mg)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 14, 2015
Last Updated
August 5, 2015
Sponsor
Inje University
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1. Study Identification

Unique Protocol Identification Number
NCT02415062
Brief Title
The Efficacy and Safety Study of High Dose Donepezil in Parkinson's Disease With Dementia
Acronym
CUPID
Official Title
The Efficacy of 23mg Versus 10mg of Donepezil in ParkInson's Disease With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inje University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
high dose donepezil (23mg)
Arm Type
Experimental
Arm Description
Patients with dementia in Parkinson's disease, who are treated with high dose donepezil (23mg)
Arm Title
standard dose denepezil (10mg)
Arm Type
Active Comparator
Arm Description
Patients with dementia in Parkinson's disease, who are treated with standard dose donepezil (10mg)
Intervention Type
Drug
Intervention Name(s)
Donepezil
Other Intervention Name(s)
aricept
Intervention Description
23mg/day for 24 weeks versus 10mg/day for 24 weeks
Primary Outcome Measure Information:
Title
Korean Mini-Mental State Examination-2 (MMSE-2)
Description
scale for general cognitive function, We used Korean version of MMSE-2 from PAR company
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Korean-Instrumental Activities of Daily Living
Description
scales for activities daily living
Time Frame
24 weeks
Title
Clinical dementia rating
Description
scales for activities of daily living
Time Frame
24 weeks
Title
Unified Parkinson's disease rating scale (UPDRS) part 3
Description
scales for motor symptoms in Parkinson's disease
Time Frame
24 weeks
Title
Modified Hoehn & Yahr stage
Description
scales for status of Parkinson's disease
Time Frame
24 weeks
Title
Schwab & England Activities of Daily Living
Description
scales for activities daily living
Time Frame
24 weeks
Title
Caregiver-Administered Neuropsychiatric Inventory
Description
scales for status of caregiver
Time Frame
24 weeks
Title
Global Deterioration Scale
Description
scales for activities of daily living
Time Frame
24 weeks
Title
Korean-Montreal Cognitive Assessment
Description
scales for cognition
Time Frame
24 weeks
Title
Semantic fluency to evaluate neuropsychiatric symptoms
Description
scales for language
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sangjin Kim, Professor
Phone
82-51-797-8736
Email
jsk120@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sangjin Kim, Professor
Organizational Affiliation
Inje University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inje university, busan paik hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang-jin kim, professor
Phone
82-10-9525-6207
Email
jsk120@hanmail.net

12. IPD Sharing Statement

Citations:
PubMed Identifier
15965198
Citation
Ravina B, Putt M, Siderowf A, Farrar JT, Gillespie M, Crawley A, Fernandez HH, Trieschmann MM, Reichwein S, Simuni T. Donepezil for dementia in Parkinson's disease: a randomised, double blind, placebo controlled, crossover study. J Neurol Neurosurg Psychiatry. 2005 Jul;76(7):934-9. doi: 10.1136/jnnp.2004.050682.
Results Reference
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PubMed Identifier
14716693
Citation
Leroi I, Brandt J, Reich SG, Lyketsos CG, Grill S, Thompson R, Marsh L. Randomized placebo-controlled trial of donepezil in cognitive impairment in Parkinson's disease. Int J Geriatr Psychiatry. 2004 Jan;19(1):1-8. doi: 10.1002/gps.993.
Results Reference
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PubMed Identifier
12023410
Citation
Aarsland D, Laake K, Larsen JP, Janvin C. Donepezil for cognitive impairment in Parkinson's disease: a randomised controlled study. J Neurol Neurosurg Psychiatry. 2002 Jun;72(6):708-12. doi: 10.1136/jnnp.72.6.708. Erratum In: J Neurol Neurosurg Psychiatry 2002 Sep;73(3):354.
Results Reference
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The Efficacy and Safety Study of High Dose Donepezil in Parkinson's Disease With Dementia

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