Clinical trial NCT02415062: The Efficacy and Safety Study of High Dose Donepezil in Parkinson's Disease With Dementia
Official title: The Efficacy of 23mg Versus 10mg of Donepezil in ParkInson's Disease With Dementia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
dementia
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2015-04-14
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Korean Mini-Mental State Examination-2 (MMSE-2)
timeFrame: 24 weeks
Secondary outcomes:
measure: Korean-Instrumental Activities of Daily Living
timeFrame: 24 weeks
measure: Clinical dementia rating
timeFrame: 24 weeks
measure: Unified Parkinson's disease rating scale (UPDRS) part 3
timeFrame: 24 weeks
measure: Modified Hoehn & Yahr stage
timeFrame: 24 weeks
measure: Schwab & England Activities of Daily Living
timeFrame: 24 weeks
measure: Caregiver-Administered Neuropsychiatric Inventory
timeFrame: 24 weeks
measure: Global Deterioration Scale
timeFrame: 24 weeks
measure: Korean-Montreal Cognitive Assessment
timeFrame: 24 weeks
measure: Semantic fluency to evaluate neuropsychiatric symptoms
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje university, busan paik hospital
Study officials:
affiliation: Inje University Haeundae Paik Hospital
name: Sangjin Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.