The CALM-AD trial – a randomised controlled trial of a cholinesterase inhibitor in the management of agitation in dementia
Ed Juszczak and Jill Mollison with Robert Howard (London), 8 UK centres, and Tony Johnson (Cambridge)
Agitation is characterised by excessive motor activity with inner tension giving rise to pacing, wandering, aggression, shouting, and nocturnal disturbance of behaviour. Current knowledge is inadequate to inform any of the key management decisions in the clinical treatment of agitation. This leads to ineffective, unnecessary and probably dangerous intervention strategies for many frail elderly people with dementia.
The CALM-AD trial seeks to answer four key questions: (1) Whether, in patients with dementia, donepezil is significantly better than placebo in the management of agitation which has not responded to a psychological intervention; (2) Whether donepezil has a significant (positive or negative) impact upon cognitive function compared to placebo; (3) Whether donepezil has a significant (positive or negative) impact upon quality of life compared to placebo; (4) The cost-effectiveness of treatment with donepezil for agitation.
CALM-AD is a multi-centre, double-blind, two-arm, placebo-controlled, parallel group randomised controlled trial. Around 950 participants with probable or possible Alzheimer's disease and clinically significant agitation will receive a 4-week intervention with a standardised psychological intervention package. Patients who remain agitated according to their score on the Cohen-Mansfield Agitation Inventory (CMAI) will be randomised to treatment withdonepezil or placebo for 12 weeks. Standardised outcome measures will assess agitation (CMAI), cognitive function measured by the severe impairment battery (SIB), other behavioural and psychiatric symptoms in dementia (NPI), quality of life (EuroQol), adverse events and a measure of health related costs.
Recruitment commenced in November 2003.
