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

May 8, 2013 updated by: Eisai Limited
A randomised, double-blind, 3-arm parallel group study comparing Aricept® with placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Wolfach, Germany
        • Parkinson Klinik Wolfach
    • Hambug
      • Hamburg, Hambug, Germany
        • Allgemeines Krankenhaus Barmbeck
  • Ireland
      • Belfast, Ireland
        • Belfast City Hospital
      • Blackpool, Ireland
        • Unit 20 Black Poo Technology Centerl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Limited

Investigators

  • Study Director: Jina Schwartz, Eisai Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Study Completion

July 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

May 10, 2013

Last Update Submitted That Met QC Criteria

May 8, 2013

Last Verified

November 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2020-E044-316

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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