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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 August 2015
• Main ID: NCT02415062
• Date of registration: 14/03/2015
• Prospective Registration: Yes
• Primary sponsor: Inje University
• Public title: The Efficacy and Safety Study of High Dose Donepezil in Parkinson's Disease With Dementia CUPID
• Scientific title: The Efficacy of 23mg Versus 10mg of Donepezil in ParkInson's Disease With Dementia
• Date of first enrolment: July 2015
• Target sample size: 150
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02415062
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Korea, Republic of

Contacts

• Name: Sangjin Kim, Professor
• Affiliation: Inje University

• Name: Sang-jin kim, professor

• Name: Sangjin Kim, Professor

Key inclusion & exclusion 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



Age minimum: 50 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: Donepezil

Primary Outcome(s)

Korean Mini-Mental State Examination-2 (MMSE-2) [Time Frame: 24 weeks]

Secondary Outcome(s)

Global Deterioration Scale [Time Frame: 24 weeks]

Caregiver-Administered Neuropsychiatric Inventory [Time Frame: 24 weeks]

Semantic fluency to evaluate neuropsychiatric symptoms [Time Frame: 24 weeks]

Korean-Montreal Cognitive Assessment [Time Frame: 24 weeks]

Clinical dementia rating [Time Frame: 24 weeks]

Schwab & England Activities of Daily Living [Time Frame: 24 weeks]

Unified Parkinson's disease rating scale (UPDRS) part 3 [Time Frame: 24 weeks]

Modified Hoehn & Yahr stage [Time Frame: 24 weeks]

Korean-Instrumental Activities of Daily Living [Time Frame: 24 weeks]

Secondary ID(s)

CUPID-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors