A randomised placebo controlled trial of a cholinesterase inhibitor in the management of agitation in dementia that is unresponsive to a psychological intervention

Can a drug called donepezil hydrochloride help people with Alzheimer’s to be less agitated?

What was this study about?

Agitation is a common symptom of Alzheimer’s disease. It can be distressing both for the person living with the disease, and for family and friends. CALM-AD was a randomised controlled trial which aimed to find out whether a drug called donepezil hydrochloride could help to reduce people’s agitation.

People who took part in this study were divided at random into two groups. People in one group were given donepezil hydrochloride for 12 weeks. People in the other group were given a placebo. Researchers measured people’s level of agitation at the beginning and end of the trial.

What difference did this study make?

This trial found that donepezil was not effective in treating agitation in people with Alzheimer's disease. There was greater cognitive deterioration in the placebo group.

The study enhanced knowledge of dementia though it produced a negative finding for control of agitation.

Type of study

Randomised trial

Contact details

Who funded the study?

The Medical Research Council and the UK charity the Alzheimer’s Society.

When did it take place?

This trial began recruiting people in November 2003. It closed to recruitment in September 2005.

Where did it take place?

Patients were recruited at eight clinical centers in England.

Who was included?

272 people with Alzheimer’s disease took part in this trial. Researchers only recruited people whose agitation did not respond to psychosocial treatment which did not include drugs.