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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
190
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
Cohen Mansfield Agitation Inventory
Neuropsychiatric Inventory
Standardized Mini-Mental State Examination
Severe Impairment Battery
Clinical Global Impression of Severity/Change
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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, United Kingdom