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In this issue of Neurology®, the results of a 48-week trial of donepezil in patients with mild cognitive impairment (MCI) are reported.1 Although the investigators found a statistically significant effect of donepezil on the modified Alzheimer disease (AD) Assessment Scale–cognitive (ADAS-cog), there was no benefit for donepezil-treated patients on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB).
At face value, the lack of benefit of donepezil on the CDR-SB in patients with MCI over nearly 1 year refutes the presumption that donepezil should be effective in MCI because it was in mild to moderate AD. Two other studies with donepezil reached nearly the same conclusion,2,3 and studies of the other cholinesterase inhibitors rivastigmine4 and galantamine5 also failed to show benefits in MCI.
However, inspection of the data in the current study1 raises questions about the adequacy of the study design. The subjects with MCI in the study did not deteriorate. Over 48 weeks, the CDR-SB ratings dropped only 0.1 point. On the modified …
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