AD2000 Protocol Summary
AD2000 is a large, simple, ‘real-life’ trial that aims to produce reliable evidence on the value of donepezil (Aricept® ) in routine practice. Previous randomised trials, among patients with mild to moderate ‘probable Alzheimer’s disease’, have established that donepezil can improve performance in cognitive function tests, but with no evidence that the drug reverses the underlying disease process. It is also not clear how the drug affects the day-to-day functioning, or behavioral disturbance, its impact on the quality of life of the patient and their carer.
AD2000 aims recruit 800 people with mild or moderate Alzheimer’s disease who will be randomly allocated either donepezil (5mg) or placebo. After 12 weeks treatment patients will be re-assessed and then continue for another year either with the same treatment (i.e. donepezil or placebo), or crossed over to the alternate treatment, again at random. (Thus three out of four patients receive at least 12 weeks of donepezil). Those allocated donepezil from week 13 onwards will be sub-randomised between 5mg and 10mg daily.
To investigate whether aspirin delays progression of dementia, suitable patients will be further randomised to receive daily aspirin or to avoid aspirin. It is anticipated that the recruitment will take about three years starting in October 1998, therefore the first results of AD2000 will become available in the year 2001.
The trial is run by the University of Birmingham Clinical Trials Unit (BCTU) and is funded by the West Midlands NHS Research and Development Executive. Donepezil is manufactured by Eisai Ltd. and marketed by Pfizer Ltd., but neither company is involved in the study beyond supply of the drug on a commercial basis.
Please note the AD2000 trial closed in October 2001.
