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VITAMIN E AND SELEGILINE FOR ALZHEIMER'S DISEASE.
Because oxidative damage plays a role in the pathogenesis of Alzheimer's disease, antioxidant drugs might delay its progression. This multicenter study examined two such agents: alpha-tocopherol (vitamin E) and selegiline (a monoamine oxidase inhibitor with antioxidant and adrenergic properties).
Researchers randomized 341 patients with moderately severe Alzheimer's disease to receive a two-year course of selegiline, alpha-tocopherol, both, or placebo. The primary endpoint was death, institutionalization, loss of ability to perform activities of daily living, or severe dementia.
Active drug therapies increased median endpoint-free survival compared with placebo, but the differences were not statistically significant. However, in an analysis that adjusted for baseline differences in the groups, there were significant delays in the median time to primary outcome in the three treatment groups compared with placebo (440 days with placebo vs. 655 days with selegiline, 670 with alpha-tocopherol, and 585 with the combination).
Comment: Selegiline and alpha-tocopherol may delay the progression of Alzheimer's disease or its symptoms. Alpha- tocopherol would seem to be preferable, since it is cheaper than selegiline and was as effective in this study. But an editorial raises several "red flags" about the trial, including the choice of endpoint, the imbalance in randomization that led to a need for statistical adjustment, and a failure of drug therapy to make an impact on several secondary endpoints (e.g., Mini-Mental State Exam score).
— AS Brett
Published in Journal Watch General Medicine May 2, 1997
Citation(s):
Sano M et al. A controlled trial of selegiline, alpha-tocopherol, or both as treatment for Alzheimer's disease. N Engl J Med 1997 Apr 24 336 1216-1222.
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Drachman DA and Leber P. Treatment of Alzheimer's disease -- searching for a breakthrough, settling for less. N Engl J Med 1997 Apr 24 336 1245-1247.
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