| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN62185868 |
| Date ISRCTN assigned | 21/09/2000 |
| Local reference number(s) | G0100070 |
| Public title | A Randomised Placebo Controlled Trial of a Cholinesterase Inhibitor in the Management of Agitation in Dementia that is Unresponsive to a Psychological Intervention |
| Scientific title |
|
| Acronym | CALM-AD Trial |
| Disease/condition/study domain | Neurosciences, psychiatry |
| Study hypothesis | To determine whether risperidone or donepezil are significantly better than placebo respectively in the management of agitation in AD that has not responded to, or is inappropriate for a standardized brief psychosocial treatment (BPST). |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Probable or possible Alzheimer's disease (AD)
2. Clinically significant agitation
3. Age >39 years
4. Resident in care facility or community resident with carer
5. Not receiving treatment with neuroleptics or chlornesterase inhibitors
6. Carer with capacity to consent. |
| Participants - exclusion criteria | 1. Known sensitivity to donepezil or resperidone
2. Severe, unstable or uncontrolled medical conditions apparent from history, physical examination or investigations
3. Current evidence of delirium
4. Patient meets criteria for Probable Dementia with Lewy Bodies (McKeith et al, 1996)
5. Low probability of treatment compliance |
| Patient information material |
|
| Anticipated start date | 01/11/2003 |
| Anticipated end date | 30/04/2006 |
| Status of trial | Completed |
| Target number of participants | 285 |
| Interventions | Randomised to receive:
1. Risperidone 0.5-1.0 mg
2. Donepezil 5-10mg
3. Placebo
For 12 weeks. |
| Primary outcome measure(s) | A reduction in score on the Cohen Mansfield Agitation Inventory. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Trial website | http://www.ctu.mrc.ac.uk/studies/calmad.asp |
| Sources of funding | Medical Research Council (UK) |
| Sponsor name | King's College London (UK) |
| Sponsor details | Strand
London
United Kingdom
WC2R 2LS |
| Sponsor telephone | +44 (0)20 7836 5454 |
| Sponsor email | ceu@kcl.ac.uk |
| Sponsor website | http://www.kcl.ac.uk/ |
| Contact name | Dr Robert Howard |
| Contact details | Division of Psychological Medicine
Institute of Psychiatry
De Crespigny Park
London
United Kingdom
SE5 8AF |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN62185868 |
| Date last extracted from ISRCTN register | 17/04/2008 |
