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NCT00142324 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2005-12-14

No results posted yet for this study

Summary

Primary Aim

To determine whether;

* Donepezil is significantly better than placebo in the management of agitation in Alzheimer's Disease that has not responded to, or is inappropriate for a standardised brief psychosocial treatment

Secondary Aims

To determine whether;

* Donepezil has a significant positive or negative impact upon quality of life compared with placebo
* whether there is a significant difference between Donepezil and placebo with respect to cognitive performance
* the cost effectiveness of the pharmacological treatment for agitation

Conditions

Interventions

DRUG

Donepezil

Sponsors & Collaborators

  • Medical Research Council

    collaborator OTHER_GOV

  • Alzheimer's Society

    collaborator OTHER

  • Institute of Psychiatry, London

    lead OTHER

Principal Investigators

  • Robert Howard · Institute of Psychiatry, London

  • Peter Bentham · Queen Elizabeth Psychiatric Hospital, Birmingham

  • Richard Brown · Institute of Psychiatry, London

  • Roger Bullock · Kingshill Research Centre, Victoria Hospital, Swindon

  • Alistair Burns · Wythenshawe Hospital, Manchester

  • Clive Holmes · Moorgreen Hospital, Southampton

  • Robin Jacoby · Warneford Hospital, Oxford

  • James Lindesay · Leicester General Hospital, Leicester

  • John O'Brien · Newcastle General Hospital, Newcastle

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-11-30
Completion
2005-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00142324 on ClinicalTrials.gov