CALM-AD

December 13, 2005 updated by: Institute of Psychiatry, London

A Randomised Placebo Controlled Trial of a Cholinesterase Inhibitor in the Management of Agitation in Dementia That is Unresponsive to a Psychological Intervention

Primary Aim

To determine whether;

  • Donepezil is significantly better than placebo in the management of agitation in Alzheimer's Disease that has not responded to, or is inappropriate for a standardised brief psychosocial treatment

Secondary Aims

To determine whether;

  • Donepezil has a significant positive or negative impact upon quality of life compared with placebo
  • whether there is a significant difference between Donepezil and placebo with respect to cognitive performance
  • the cost effectiveness of the pharmacological treatment for agitation

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

190

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B15 2QZ
        • Queen Elizabeth Psychiatric Hospital
      • Leicester, United Kingdom, LE5 4PW
        • Department of Psychiatry for the Elderly, Leicester General Hospital
      • London, United Kingdom, SE5 8AF
        • Institute of Psychiatry, King's College, London
      • Manchester, United Kingdom, M23 9LT
        • Old Age Psychiatry, Wythenshawe Hospital, Manchester
      • Newcastle upon Tyne, United Kingdom, NE4 6BE
        • Institute for Ageing and Health, Newcastle General Hospital, Newcastle
      • Oxford, United Kingdom, OX3 7JX
        • Department of Psychiatry, Warneford Hospital, Oxford
      • Southampton, United Kingdom, S030 3JB
        • MARC, Moorgreen Hospital, Southamptom
      • Swindon, United Kingdom, SN1 4HZ
        • Department of Old Age Psychiatry, Victoria Hospital, Swindon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria: a diagnosis of dementia consistent with Diagnostic and Statistical Manual of Mental Health Disorders, revised 3rd edition (DSM-III-R) (APA, 1987) National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) diagnostic criteria for probably or possible AD (MKhann et al, 1984) (Appendix 6) clinically significant agitation (defined as causing distress to patient and at least moderate management problems for carers on at least two days per week for a two week period, together with a Cohen Mansfield Agitation Inventory (CMAI) (Cohen-Mansfield, 1986) (Appendix 11 A) score >39 age >39 years resident in care facility or community living with a carer not receiving treatment with neuroleptics or cholinesterase inhibitors currently or in the past four weeks and responsible clinician not considering treatment with cholinesterase inhibitor for the next 16 weeks taking into account the clinical evidence base and NICE guideline (NICE, 2001) patient with capacity willing to consent to study or will to participate in study if lacking capacity carer with capacity willing to consent to study and in agreement for patient lacking capacity to participate if patient willing to participate

-

Exclusion Criteria:known sensitivity to Donepezil severe, unstable or uncontrolled medical conditions apparent from history, physical examination or investigations current evidence of delirium patient meets criteria for Probably Dementia with Lewy Bodies (McKeith et al, 1996) low probability of treatment compliance

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Cohen Mansfield Agitation Inventory

Secondary Outcome Measures

Outcome Measure
Neuropsychiatric Inventory
Standardized Mini-Mental State Examination
Severe Impairment Battery
Clinical Global Impression of Severity/Change

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Psychiatry, London

Collaborators

Medical Research Council
Alzheimer's Society

Investigators

  • Principal Investigator: Robert Howard, Institute of Psychiatry, London
  • Principal Investigator: Peter Bentham, Queen Elizabeth Psychiatric Hospital, Birmingham
  • Principal Investigator: Richard Brown, Institute of Psychiatry, London
  • Principal Investigator: Roger Bullock, Kingshill Research Centre, Victoria Hospital, Swindon
  • Principal Investigator: Alistair Burns, Wythenshawe Hospital, Manchester
  • Principal Investigator: Clive Holmes, Moorgreen Hospital, Southampton
  • Principal Investigator: Robin Jacoby, Warneford Hospital, Oxford
  • Principal Investigator: James Lindesay, Leicester General Hospital, Leicester
  • Principal Investigator: John O'Brien, Newcastle General Hospital, Newcastle

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Estimate)

December 14, 2005

Last Update Submitted That Met QC Criteria

December 13, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISRCTN62185868

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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