CALM-AD
Recruitment status was Active, not recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: Donepezil |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind 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 |
- Cohen Mansfield Agitation Inventory
- Neuropsychiatric Inventory
- Standardized Mini-Mental State Examination
- Severe Impairment Battery
- Clinical Global Impression of Severity/Change
| Estimated Enrollment: | 190 |
| Study Start Date: | November 2003 |
| Estimated Study Completion Date: | December 2005 |
Eligibility| 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
-
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
-
Contacts and Locations| 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 | |
| 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 |
More Information
No publications provided by Institute of Psychiatry, London
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00142324 History of Changes |
| Other Study ID Numbers: | ISRCTN62185868 |
| Study First Received: | September 1, 2005 |
| Last Updated: | December 13, 2005 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Institute of Psychiatry, London:
|
Dementia |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Cholinesterase Inhibitors |
Donepezil Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013