CALM-AD

Study Overview
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Brief Summary
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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

Official Title
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A Randomised Placebo Controlled Trial of a Cholinesterase Inhibitor in the Management of Agitation in Dementia That is Unresponsive to a Psychological Intervention

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: Donepezil


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Donepezil|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohen Mansfield Agitation Inventory |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychiatric Inventory |  |  | 
| Standardized Mini-Mental State Examination |  |  | 
| Severe Impairment Battery |  |  | 
| Clinical Global Impression of Severity/Change |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia