SELEGILINE/VITAMIN E STUDY COMPOSITE ENDPOINTS MAY NOT BE SURROGATE FOR ALZHEIMER PROGRESSION -- FDA's LEBER; LACK OF EFFECT ON COGNITIVE SCORES "PERPLEXING"
Executive Summary
Composite endpoints used in a study of Somerset's Eldepryl (selegiline) and alpha-tocopheral (vitamin E) may not be appropriate surrogates for progression in Alzheimer's disease, FDA Neuropharmacological Drug Products Division Director Paul Leber, MD, suggests in a New England Journal of Medicine editorial.