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

Phase 3CompletedNCT00165815

Eisai Limited

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Dementia With Parkinson's Disease

Interventions

ARICEPTDRUG

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

Locations (4)

Allgemeines Krankenhaus Barmbeck

Hamburg, Hambug, Germany

Parkinson Klinik Wolfach

Wolfach, Wolfach, Germany

Belfast City Hospital

Belfast, Belfast, Ireland

Unit 20 Black Poo Technology Centerl

Blackpool, Blackpool, Ireland

Outcomes

Primary Outcomes

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.

Data from ClinicalTrials.gov

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