Eli Lilly’s experimental Alzheimer’s medicine donanemab showed some of the best early results seen by pharmaceutical researchers in the field. What divides many researchers is whether that is a reason for excitement or not.
The results, released Saturday at the International Conference on Alzheimer’s & Parkinson Diseases and published in the New England Journal of Medicine, are from a Phase 2 study, usually used by pharmaceutical companies to test whether a drug merits testing in a larger Phase 3 study that could result in approval. While top-line results were previously outlined in a Lilly press release, they represent a high watermark for studies in Alzheimer’s. This is the first time a Phase 2 study of a drug that attempts to slow Alzheimer’s, not just allay patients’ symptoms, has had a positive outcome.
The 131 participants in the trial who received donanemab did not see their conditions improve; rather they saw a slowdown in their cognitive decline. Researchers said that, on the 144-point Integrated Alzheimer’s Disease Research Scale, these patients saw a decline of 6.86 points compared to a 10-point decline in those who received placebo. The changes were seen over 76 weeks.
Encouraging news from Lilly suggests provides more evidence that medicines targeted to amyloid can alter the course of AD, and that investigators are learning how to use this strategy effectively. This is part of the normative experience that a mature body of basic research is requisite for successful drug development. https://pubmed.ncbi.nlm.nih.gov/26243074/