A Randomised Placebo Controlled Trial of a Cholinesterase Inhibitor in the Management of Agitation in Dementia that is Unresponsive to a Psychological Intervention
| ISRCTN | ISRCTN62185868 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62185868 |
| ClinicalTrials.gov (NCT) | NCT00142324 |
| Protocol serial number | G0100070 |
| Sponsor | King's College London (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- Submission date
- 21/09/2000
- Registration date
- 21/09/2000
- Last edited
- 07/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Robert Howard
Scientific
Scientific
Division of Psychological Medicine
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | CALM-AD Trial |
| Study objectives | 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). |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Neurosciences, psychiatry |
| Intervention | Randomised to receive: 1. Risperidone 0.5-1.0 mg 2. Donepezil 5-10mg 3. Placebo For 12 weeks. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Donepezil |
| Primary outcome measure(s) |
A reduction in score on the Cohen Mansfield Agitation Inventory. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/04/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 285 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/11/2003 |
| Date of final enrolment | 30/04/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Division of Psychological Medicine
London
SE5 8AF
United Kingdom
SE5 8AF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 04/10/2007 | Yes | No |
