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By Roy Jones

St. Martin's clinic, tub, united kingdom.

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The key study involved 473 patients and compared once-daily doses of 5 or 10 mg with placebo given for 24 weeks [ 71. The primary endpoints were to show improvement on the ADAS-Cog and the overall global effect using the Clinicians’ Interview-Based Impression of Change (CIB1C)-Plus. The CIBIC-Plus used was a semistructured instrument intended to examine four major areas of patient function: general, cognitive, behavioural and activities of daily living. There were significant improvements in both primary assessments.

It is also important to be clear whose QOL is being assessed: is it the patient’s or is it the carer’s? A patient’s scale was adapted for use in clinical trials with donepezil as an attempt to look at QOL. It was totally unsatisfactory and did not give positive results yet left the company open to unfair criticism that the drug did not affect QOL. The CPMP guidelines [2] acknowledge this issue stating that ‘although QOL is an important dimension of the consequences of diseases, the lack of validation of its assessment in AD does not allow specific recommendations to be made as yet’.

The frequency of assistance is rated on a 3-point scale for each item giving an overall score ranging from 33 (best) to 99 (worst). The IDDD has been used in one of the pivotal trials with donepezil. Disability Assessment for Dementia This ADL rating takes about 20 min to complete either as a questionnaire completed by the caregiver or as a structured interview of the caregiver. It assesses the ability of the patient to initiate, plan, organize and perform basic (for example, eating) and more complex (for example, leisure and housework) instrumental ADL.

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