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

NCT ID: NCT00165815

Last Updated: 2013-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-08-31
• Study Completion Date: 2005-07-31

Brief Summary

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

Conditions

Dementia With Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

ARICEPT

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Limited

INDUSTRY

Sponsor Role: lead

Principal Investigators

Jina Schwartz

Role: STUDY_DIRECTOR

Eisai Limited

Locations

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

Countries

Germany; Ireland

Other Identifiers

E2020-E044-316

Identifier Type: -

Identifier Source: org_study_id