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

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 2

Age range

50 years - 80 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

10 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Double masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Inje University

Study start

2015-07

Primary completion

2016-12 Actual

Study completion

2017-06 Actual

First posted

Apr 14, 2015 Estimated

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.