Trial record 2 of 5 for:    CUPID

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Inje University
Sponsor:
Information provided by (Responsible Party):
Sangjin Kim, Inje University
ClinicalTrials.gov Identifier:
NCT02415062
First received: March 14, 2015
Last updated: August 5, 2015
Last verified: August 2015
  Purpose
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 Intervention Phase
Parkinson's Disease
Drug: Donepezil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy of 23mg Versus 10mg of Donepezil in ParkInson's Disease With Dementia

Resource links provided by NLM:


Further study details as provided by Inje University:

Primary Outcome Measures:
  • Korean Mini-Mental State Examination-2 (MMSE-2) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    scale for general cognitive function, We used Korean version of MMSE-2 from PAR company


Secondary Outcome Measures:
  • Korean-Instrumental Activities of Daily Living [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    scales for activities daily living

  • Clinical dementia rating [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    scales for activities of daily living

  • Unified Parkinson's disease rating scale (UPDRS) part 3 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    scales for motor symptoms in Parkinson's disease

  • Modified Hoehn & Yahr stage [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    scales for status of Parkinson's disease

  • Schwab & England Activities of Daily Living [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    scales for activities daily living

  • Caregiver-Administered Neuropsychiatric Inventory [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    scales for status of caregiver

  • Global Deterioration Scale [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    scales for activities of daily living

  • Korean-Montreal Cognitive Assessment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    scales for cognition

  • Semantic fluency to evaluate neuropsychiatric symptoms [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    scales for language


Estimated Enrollment: 150
Study Start Date: July 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02415062

Contacts
Contact: Sangjin Kim, Professor 82-51-797-8736 jsk120@hanmail.net

Locations
Korea, Republic of
Inje university, busan paik hospital Recruiting
Busan, Korea, Republic of
Contact: Sang-jin kim, professor    82-10-9525-6207    jsk120@hanmail.net   
Sponsors and Collaborators
Inje University
Investigators
Principal Investigator: Sangjin Kim, Professor Inje University
  More Information

Publications:
Responsible Party: Sangjin Kim, Busan Paik Hospital, Inje University, Inje University
ClinicalTrials.gov Identifier: NCT02415062     History of Changes
Other Study ID Numbers: CUPID-01 
Study First Received: March 14, 2015
Last Updated: August 5, 2015
Health Authority: Korea: Ministry of Food and Drug Safety

Keywords provided by Inje University:
Parkinson's disease
dementia

Additional relevant MeSH terms:
Parkinson Disease
Dementia
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents

ClinicalTrials.gov processed this record on July 25, 2016