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

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00165815
First received: September 13, 2005
Last updated: May 8, 2013
Last verified: November 2005
  Purpose

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


Condition Intervention Phase
Dementia With Parkinson's Disease
Drug: ARICEPT
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • 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.

Study Start Date: August 2002
Estimated Study Completion Date: July 2005
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165815

Locations
Germany
Allgemeines Krankenhaus Barmbeck
Hamburg, Hambug, Germany
Parkinson Klinik Wolfach
Wolfach, Germany
Ireland
Belfast City Hospital
Belfast, Ireland
Unit 20 Black Poo Technology Centerl
Blackpool, Ireland
Sponsors and Collaborators
Eisai Limited
Investigators
Study Director: Jina Schwartz Eisai Limited
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00165815     History of Changes
Other Study ID Numbers: E2020-E044-316
Study First Received: September 13, 2005
Last Updated: May 8, 2013
Health Authority: European Union: European Medicines Agency

Additional relevant MeSH terms:
Dementia
Parkinson Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Neurodegenerative Diseases
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014