Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
190 participants
INTERVENTIONAL
2003-11-30
2005-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
PREVENTION
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Donepezil
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
40 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical Research Council
OTHER_GOV
Alzheimer's Society
OTHER
Institute of Psychiatry, London
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert Howard
Role: PRINCIPAL_INVESTIGATOR
Institute of Psychiatry, London
Peter Bentham
Role: PRINCIPAL_INVESTIGATOR
Queen Elizabeth Psychiatric Hospital, Birmingham
Richard Brown
Role: PRINCIPAL_INVESTIGATOR
Institute of Psychiatry, London
Roger Bullock
Role: PRINCIPAL_INVESTIGATOR
Kingshill Research Centre, Victoria Hospital, Swindon
Alistair Burns
Role: PRINCIPAL_INVESTIGATOR
Wythenshawe Hospital, Manchester
Clive Holmes
Role: PRINCIPAL_INVESTIGATOR
Moorgreen Hospital, Southampton
Robin Jacoby
Role: PRINCIPAL_INVESTIGATOR
Warneford Hospital, Oxford
James Lindesay
Role: PRINCIPAL_INVESTIGATOR
Leicester General Hospital, Leicester
John O'Brien
Role: PRINCIPAL_INVESTIGATOR
Newcastle General Hospital, Newcastle
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Queen Elizabeth Psychiatric Hospital
Birmingham, , United Kingdom
Department of Psychiatry for the Elderly, Leicester General Hospital
Leicester, , United Kingdom
Institute of Psychiatry, King's College, London
London, , United Kingdom
Old Age Psychiatry, Wythenshawe Hospital, Manchester
Manchester, , United Kingdom
Institute for Ageing and Health, Newcastle General Hospital, Newcastle
Newcastle upon Tyne, , United Kingdom
Department of Psychiatry, Warneford Hospital, Oxford
Oxford, , United Kingdom
MARC, Moorgreen Hospital, Southamptom
Southampton, , United Kingdom
Department of Old Age Psychiatry, Victoria Hospital, Swindon
Swindon, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Howard RJ, Juszczak E, Ballard CG, Bentham P, Brown RG, Bullock R, Burns AS, Holmes C, Jacoby R, Johnson T, Knapp M, Lindesay J, O'Brien JT, Wilcock G, Katona C, Jones RW, DeCesare J, Rodger M; CALM-AD Trial Group. Donepezil for the treatment of agitation in Alzheimer's disease. N Engl J Med. 2007 Oct 4;357(14):1382-92. doi: 10.1056/NEJMoa066583.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ISRCTN62185868
Identifier Type: -
Identifier Source: org_study_id