Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00142324
Protocol/serial number
G0100070
Study information
Scientific title
Acronym
CALM-AD Trial
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).
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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 names
Donepezil
Primary outcome measures
A reduction in score on the Cohen Mansfield Agitation Inventory.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/2003
Overall trial end date
30/04/2006
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
285
Participant 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
Recruitment start date
01/11/2003
Recruitment end date
30/04/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Division of Psychological Medicine
London
SE5 8AF
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
Strand
London
WC2R 2LS
United Kingdom
+44 (0)20 7836 5454
ceu@kcl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17914039
Publication citations
-
Results
Howard RJ, Juszczak E, Ballard CG, Bentham P, Brown RG, Bullock R, Burns AS, Holmes C, Jacoby R, Johnson T, Knapp M, Lindesay J, O'Brien JT, Wilcock G, Katona C, Jones RW, DeCesare J, Rodger M, , Donepezil for the treatment of agitation in Alzheimer's disease., N. Engl. J. Med., 2007, 357, 14, 1382-1392, doi: 10.1056/NEJMoa066583.