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 |
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DOI | https://doi.org/10.1186/ISRCTN62185868 |
ClinicalTrials.gov number | NCT00142324 |
Secondary identifying numbers | G0100070 |
- 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
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Donepezil |
Primary outcome measure | A reduction in score on the Cohen Mansfield Agitation Inventory. |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/11/2003 |
Completion date | 30/04/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 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
- England
- United Kingdom
Study participating centre
Division of Psychological Medicine
London
SE5 8AF
United Kingdom
SE5 8AF
United Kingdom
Sponsor information
King's College London (UK)
University/education
University/education
Strand
London
WC2R 2LS
England
United Kingdom
Phone | +44 (0)20 7836 5454 |
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ceu@kcl.ac.uk | |
Website | http://www.kcl.ac.uk/ |
https://ror.org/0220mzb33 |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | 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 |