This trial is active, not recruiting.

Condition alzheimer's disease
Treatment donepezil
Phase phase 4
Sponsor Institute of Psychiatry, London
Collaborator Medical Research Council
Start date November 2003
End date December 2005
Trial size 190 participants
Trial identifier NCT00142324, ISRCTN62185868


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking double-blind
Primary purpose prevention

Primary Outcomes

Cohen Mansfield Agitation Inventory
time frame:

Secondary Outcomes

Neuropsychiatric Inventory
time frame:
Standardized Mini-Mental State Examination
time frame:
Severe Impairment Battery
time frame:
Clinical Global Impression of Severity/Change
time frame:

Eligibility Criteria

Male or female participants at least 40 years old.

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 -

Additional Information

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
Principal investigator Robert Howard
Trial information was received from ClinicalTrials.gov and was last updated in December 2005.
Information provided to ClinicalTrials.gov by Institute of Psychiatry, London.