| Authors | Petersen RC, Thomas RG, Grundman M, Bennett D, Doody R, Ferris S, Galasko D, Jin S, Kaye J, Levey A, Pfeiffer E, Sano M, van Dyck CH, Thal LJ; Alzheimer's Disease Cooperative Study Group. | |
| Title | Vitamin E and donepezil for the treatment of mild cognitive impairment. | |
| Full source | N Engl J Med. 2005 Jun 9;352(23):2379-88. | |
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| Abstract | BACKGROUND:
Mild cognitive impairment is a transitional state between the cognitive
changes of normal aging and early Alzheimer's disease. METHODS: In a double-blind
study, we evaluated subjects with the amnestic subtype of mild cognitive
impairment. Subjects were randomly assigned to receive 2000 IU of vitamin
E daily, 10 mg of donepezil daily, or placebo for three years. The primary
outcome was clinically possible or probable Alzheimer's disease; secondary
outcomes were cognition and function. RESULTS: A total of 769 subjects were
enrolled, and possible or probable Alzheimer's disease developed in 212.
The overall rate of progression from mild cognitive impairment to Alzheimer's
disease was 16 percent per year. As compared with the placebo group, there
were no significant differences in the probability of progression to Alzheimer's
disease in the vitamin E group (hazard ratio, 1.02; 95 percent confidence
interval, 0.74 to 1.41; P=0.91) or the donepezil group (hazard ratio, 0.80;
95 percent confidence interval, 0.57 to 1.13; P=0.42) during the three years
of treatment. Prespecified analyses of the treatment effects at 6-month
intervals showed that as compared with the placebo group, the donepezil
group had a reduced likelihood of progression to Alzheimer's disease during
the first 12 months of the study (P=0.04), a finding supported by the secondary
outcome measures. Among carriers of one or more apolipoprotein E epsilon4
alleles, the benefit of donepezil was evident throughout the three-year
follow-up. There were no significant differences in the rate of progression
to Alzheimer's disease between the vitamin E and placebo groups at any point,
either among all patients or among apolipoprotein E epsilon4 carriers. CONCLUSIONS:
Vitamin E had no benefit in patients with mild cognitive impairment. Although
donepezil therapy was associated with a lower rate of progression to Alzheimer's
disease during the first 12 months of treatment, the rate of progression
to Alzheimer's disease after three years was not lower among patients treated
with donepezil than among those given placebo |
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