The Efficacy, Tolerability and Safety of Donepezil (Aricept) in Parkinson's Disease Patients With Dementia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00165815

Enrollment

Unknown

Registered

2005-09-14

Start date

2002-08-31

Completion date

2005-07-31

Last updated

2013-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia With Parkinson's Disease

Brief summary

A randomised, double-blind, 3-arm parallel group study comparing Aricept® with placebo.

Interventions

DRUGARICEPT

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Inclusion criteria

Patients with an established diagnosis of PD and dementia, who fulfill all of the inclusion criteria and none of the

Exclusion criteria

listed below, will be eligible for enrolment into this study. Best efforts must be made on clinical grounds to exclude patients with DLB and AD. The key inclusion criteria in this respect is the onset of dementia documented to have occurred at least 1 year after the diagnosis of PD.

Design outcomes

Primary

Measure	Time frame
PD patients with dementia will be screened up to 4 weeks prior to initiating dose administration. Baseline measurement on efficacy measures will be conducted at baseline, after which the first dose of study medication will be administered.	—

Countries

Germany, Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026