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

Parkinson's Disease Clinical Trial

— CUPID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02415062
• Other study ID #: CUPID-01
• Status: Recruiting
• Phase: Phase 2
• First received: March 14, 2015
• Last updated: August 5, 2015
• Start date: July 2015
• Est. completion date: December 2017

Study information

• Verified date: August 2015
• Source: Inje University
• Contact: Sangjin Kim, Professor
• Phone: 82-51-797-8736
• Email: jsk120[@]hanmail.net
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Donepezil
23mg/day for 24 weeks versus 10mg/day for 24 weeks

Locations

Country	Name	City	State
Korea, Republic of	Inje university, busan paik hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. Erratum in: J Neurol Neurosurg Psychiatry 2002 Sep;73(3):354. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Korean Mini-Mental State Examination-2 (MMSE-2)	scale for general cognitive function, We used Korean version of MMSE-2 from PAR company	24 weeks	No
Secondary	Korean-Instrumental Activities of Daily Living	scales for activities daily living	24 weeks	No
Secondary	Clinical dementia rating	scales for activities of daily living	24 weeks	No
Secondary	Unified Parkinson's disease rating scale (UPDRS) part 3	scales for motor symptoms in Parkinson's disease	24 weeks	No
Secondary	Modified Hoehn & Yahr stage	scales for status of Parkinson's disease	24 weeks	No
Secondary	Schwab & England Activities of Daily Living	scales for activities daily living	24 weeks	No
Secondary	Caregiver-Administered Neuropsychiatric Inventory	scales for status of caregiver	24 weeks	No
Secondary	Global Deterioration Scale	scales for activities of daily living	24 weeks	No
Secondary	Korean-Montreal Cognitive Assessment	scales for cognition	24 weeks	No
Secondary	Semantic fluency to evaluate neuropsychiatric symptoms	scales for language	24 weeks	No