CALM-AD

Phase 4

• Conditions: Alzheimer's Disease

• Registration Number: NCT00142324
• Lead Sponsor: Institute of Psychiatry, London

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Status Verified: 2005-09
• Study First Submitted: 2005-09-01
• Study First Submitted QC: 2005-09-01
• Study First Posted: 2005-09-02
• Study Completion: 2005-12
• Last Update Submitted: 2005-12-13
• Last Update Posted: 2005-12-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 190

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Cohen Mansfield Agitation Inventory

Secondary Outcome Measures

Name	Time	Method
Neuropsychiatric Inventory
Standardized Mini-Mental State Examination
Severe Impairment Battery
Clinical Global Impression of Severity/Change

Trial Locations

Locations (8)

Queen Elizabeth Psychiatric Hospital; 🇬🇧 Birmingham, United Kingdom

Department of Psychiatry for the Elderly, Leicester General Hospital; 🇬🇧 Leicester, United Kingdom

Institute for Ageing and Health, Newcastle General Hospital, Newcastle; 🇬🇧 Newcastle upon Tyne, United Kingdom

MARC, Moorgreen Hospital, Southamptom; 🇬🇧 Southampton, United Kingdom

Old Age Psychiatry, Wythenshawe Hospital, Manchester; 🇬🇧 Manchester, United Kingdom

Department of Old Age Psychiatry, Victoria Hospital, Swindon; 🇬🇧 Swindon, United Kingdom

Department of Psychiatry, Warneford Hospital, Oxford; 🇬🇧 Oxford, United Kingdom

Institute of Psychiatry, King's College, London; 🇬🇧 London, United Kingdom