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

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inje University
• Treatments: Donepezil

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