CALM-AD

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00142324
• Other study ID #: ISRCTN62185868
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 1, 2005
• Last updated: December 13, 2005
• Start date: November 2003
• Est. completion date: December 2005

Study information

• Verified date: September 2005
• Source: Institute of Psychiatry, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 190
• Est. completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Donepezil

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth Psychiatric Hospital	Birmingham
United Kingdom	Department of Psychiatry for the Elderly, Leicester General Hospital	Leicester
United Kingdom	Institute of Psychiatry, King's College, London	London
United Kingdom	Old Age Psychiatry, Wythenshawe Hospital, Manchester	Manchester
United Kingdom	Institute for Ageing and Health, Newcastle General Hospital, Newcastle	Newcastle upon Tyne
United Kingdom	Department of Psychiatry, Warneford Hospital, Oxford	Oxford
United Kingdom	MARC, Moorgreen Hospital, Southamptom	Southampton
United Kingdom	Department of Old Age Psychiatry, Victoria Hospital, Swindon	Swindon

Sponsors (3)

Lead Sponsor	Collaborator
Institute of Psychiatry, London	Alzheimer's Society, Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohen Mansfield Agitation Inventory
Secondary	Neuropsychiatric Inventory
Secondary	Standardized Mini-Mental State Examination
Secondary	Severe Impairment Battery
Secondary	Clinical Global Impression of Severity/Change