NCT00165815

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 2002

Typical duration for phase_3

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

May 10, 2013

Status Verified

November 1, 2005

First QC Date

September 13, 2005

Last Update Submit

May 8, 2013

Conditions

Dementia With Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

ARICEPTDRUG

Eligibility Criteria

Age40 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Allgemeines Krankenhaus Barmbeck

Hamburg, Hambug, Germany

Location

Parkinson Klinik Wolfach

Wolfach, Wolfach, Germany

Location

Belfast City Hospital

Belfast, Belfast, Ireland

Location

Unit 20 Black Poo Technology Centerl

Blackpool, Blackpool, Ireland

Location

MeSH Terms

Interventions

Donepezil

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • Jina Schwartz

    Eisai Limited

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 14, 2005

Study Start

August 1, 2002

Study Completion

July 1, 2005

Last Updated

May 10, 2013

Record last verified: 2005-11

Locations

DE(2)IE(2)