Condition category
Nervous System Diseases
Date applied
21/09/2000
Date assigned
21/09/2000
Last edited
07/09/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Robert Howard

ORCID ID

Contact details

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

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

http://www.kcl.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

  1. 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.

Additional files

Editorial Notes