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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00142324
Recruitment Status : Unknown
Verified September 2005 by Institute of Psychiatry, London.
Recruitment status was:  Active, not recruiting
First Posted : September 2, 2005
Last Update Posted : December 14, 2005
Medical Research Council
Alzheimer's Society
Information provided by:
Institute of Psychiatry, London

Brief 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

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Donepezil Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Randomised Placebo Controlled Trial of a Cholinesterase Inhibitor in the Management of Agitation in Dementia That is Unresponsive to a Psychological Intervention
Study Start Date : November 2003
Study Completion Date : December 2005

Primary Outcome Measures :
  1. Cohen Mansfield Agitation Inventory

Secondary Outcome Measures :
  1. Neuropsychiatric Inventory
  2. Standardized Mini-Mental State Examination
  3. Severe Impairment Battery
  4. Clinical Global Impression of Severity/Change

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria: a diagnosis of dementia consistent with Diagnostic and Statistical Manual of Mental Health Disorders, revised 3rd edition (DSM-III-R) (APA, 1987) National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) diagnostic criteria for probably or possible AD (MKhann et al, 1984) (Appendix 6) clinically significant agitation (defined as causing distress to patient and at least moderate management problems for carers on at least two days per week for a two week period, together with a Cohen Mansfield Agitation Inventory (CMAI) (Cohen-Mansfield, 1986) (Appendix 11 A) score >39 age >39 years resident in care facility or community living with a carer not receiving treatment with neuroleptics or cholinesterase inhibitors currently or in the past four weeks and responsible clinician not considering treatment with cholinesterase inhibitor for the next 16 weeks taking into account the clinical evidence base and NICE guideline (NICE, 2001) patient with capacity willing to consent to study or will to participate in study if lacking capacity carer with capacity willing to consent to study and in agreement for patient lacking capacity to participate if patient willing to participate


Exclusion Criteria:known sensitivity to Donepezil severe, unstable or uncontrolled medical conditions apparent from history, physical examination or investigations current evidence of delirium patient meets criteria for Probably Dementia with Lewy Bodies (McKeith et al, 1996) low probability of treatment compliance


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00142324

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United Kingdom
Queen Elizabeth Psychiatric Hospital
Birmingham, United Kingdom, B15 2QZ
Department of Psychiatry for the Elderly, Leicester General Hospital
Leicester, United Kingdom, LE5 4PW
Institute of Psychiatry, King's College, London
London, United Kingdom, SE5 8AF
Old Age Psychiatry, Wythenshawe Hospital, Manchester
Manchester, United Kingdom, M23 9LT
Institute for Ageing and Health, Newcastle General Hospital, Newcastle
Newcastle upon Tyne, United Kingdom, NE4 6BE
Department of Psychiatry, Warneford Hospital, Oxford
Oxford, United Kingdom, OX3 7JX
MARC, Moorgreen Hospital, Southamptom
Southampton, United Kingdom, S030 3JB
Department of Old Age Psychiatry, Victoria Hospital, Swindon
Swindon, United Kingdom, SN1 4HZ
Sponsors and Collaborators
Institute of Psychiatry, London
Medical Research Council
Alzheimer's Society
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Principal Investigator: Robert Howard Institute of Psychiatry, London
Principal Investigator: Peter Bentham Queen Elizabeth Psychiatric Hospital, Birmingham
Principal Investigator: Richard Brown Institute of Psychiatry, London
Principal Investigator: Roger Bullock Kingshill Research Centre, Victoria Hospital, Swindon
Principal Investigator: Alistair Burns Wythenshawe Hospital, Manchester
Principal Investigator: Clive Holmes Moorgreen Hospital, Southampton
Principal Investigator: Robin Jacoby Warneford Hospital, Oxford
Principal Investigator: James Lindesay Leicester General Hospital, Leicester
Principal Investigator: John O'Brien Newcastle General Hospital, Newcastle

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00142324     History of Changes
Other Study ID Numbers: ISRCTN62185868
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: December 14, 2005
Last Verified: September 2005
Keywords provided by Institute of Psychiatry, London:
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents