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

NCT01327859 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 357

Last updated 2015-11-03

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of donepezil (Aricept) in Parkinson's Disease (PD) patients with dementia.

Conditions

Interventions

DRUG

Prior Donepezil 5mg

Received 5 mg donepezil once daily during the preceding double-blind study, E2020-G000-316. Received open-label 5 or 10 mg donepezil during the present study.

DRUG

Prior Donzepezil 10mg

Received 10 mg donepezil once daily during the preceding double-blind study, E2020-G000-316 . Received open-label 5 or 10 mg donepezil during the present study.

DRUG

Prior Placebo

Received placebo once daily during the preceding double-blind study, E2020-G000-316. Received open-label 5 or 10 mg donepezil during the present study.

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Harre · Eisai Limited

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2006-07-31
Completion
2006-07-31

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01327859 on ClinicalTrials.gov