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
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

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study acronymCALM-AD Trial
Study objectivesTo 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) studiedNeurosciences, psychiatry
InterventionRandomised to receive:
1. Risperidone 0.5-1.0 mg
2. Donepezil 5-10mg
3. Placebo
For 12 weeks.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Donepezil
Primary outcome measureA reduction in score on the Cohen Mansfield Agitation Inventory.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/11/2003
Completion date30/04/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants285
Key inclusion criteria1. 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 criteria1. 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 enrolment01/11/2003
Date of final enrolment30/04/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Division of Psychological Medicine
London
SE5 8AF
United Kingdom

Sponsor information

King's College London (UK)
University/education

Strand
London
WC2R 2LS
England
United Kingdom

Phone +44 (0)20 7836 5454
Email ceu@kcl.ac.uk
Website http://www.kcl.ac.uk/
ROR logo "ROR" https://ror.org/0220mzb33

Funders

Funder type

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

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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