Status:
UNKNOWN
CALM-AD
Lead Sponsor:
Institute of Psychiatry, London
Collaborating Sponsors:
Medical Research Council
Alzheimer's Society
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE4
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 standard...
Eligibility Criteria
Inclusion
- 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
- 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
- \-
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT00142324
Start Date
November 1 2003
End Date
December 1 2005
Last Update
December 14 2005
Active Locations (8)
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1
Queen Elizabeth Psychiatric Hospital
Birmingham, United Kingdom, B15 2QZ
2
Department of Psychiatry for the Elderly, Leicester General Hospital
Leicester, United Kingdom, LE5 4PW
3
Institute of Psychiatry, King's College, London
London, United Kingdom, SE5 8AF
4
Old Age Psychiatry, Wythenshawe Hospital, Manchester
Manchester, United Kingdom, M23 9LT