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Sponsors and Collaborators: |
Institute of Psychiatry, London Medical Research Council Alzheimer's Society |
Information provided by: | Institute of Psychiatry, London |
ClinicalTrials.gov Identifier: | NCT00142324 |
Primary Aim
To determine whether;
Secondary Aims
To determine whether;
Condition | Intervention | Phase |
Alzheimer's Disease |
Drug: Donepezil |
Phase IV |
Genetics Home Reference related topics: | Alzheimer disease |
MedlinePlus related topics: | Alzheimer's Disease Dementia |
ChemIDplus related topics: | Donepezil E 2020 |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 190 |
Study Start Date: | November 2003 |
Estimated Study Completion Date: | December 2005 |
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
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
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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
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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 | |||||
Department of Old Age Psychiatry, Victoria Hospital, Swindon | |||||
Swindon, United Kingdom, SN1 4HZ | |||||
Department of Psychiatry, Warneford Hospital, Oxford | |||||
Oxford, United Kingdom, OX3 7JX | |||||
MARC, Moorgreen Hospital, Southamptom | |||||
Southampton, United Kingdom, S030 3JB | |||||
Institute for Ageing and Health, Newcastle General Hospital, Newcastle | |||||
Newcastle upon Tyne, United Kingdom, NE4 6BE |
Institute of Psychiatry, London |
Medical Research Council |
Alzheimer's Society |
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 |
Study ID Numbers: | ISRCTN62185868 |
First Received: | September 1, 2005 |
Last Updated: | December 13, 2005 |
ClinicalTrials.gov Identifier: | NCT00142324 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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