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 number	NCT00142324
Secondary identifying numbers	G0100070

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Robert Howard
Scientific

Division of Psychological Medicine
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom

Study design	Randomised controlled trial
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

Participant type(s)	Patient
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

Division of Psychological Medicine

London
SE5 8AF
United Kingdom

King's College London (UK)
University/education

Strand
London
WC2R 2LS
England
United Kingdom

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Intention to publish date
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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	04/10/2007		Yes	No