NCT02415062

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Inje University · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Donepezil	23mg/day for 24 weeks versus 10mg/day for 24 weeks

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-10-01
• Completion: 2017-12-01
• First posted: 2015-04-14
• Last updated: 2015-08-06

Locations

1 site across 1 country: South Korea