When planning prospective clinical trials, one of trickiest challenges facing researchers lies in picking the right targets and drugs. In planning a prevention trial, for example, they must integrate strict safety requirements with data from existing research while also minimizing the possibility that future studies conducted during the trial’s multi-year duration will not call into question the original design.
This perennial problem was underscored recently, when the Washington-based consumer advocacy group Public Citizen sent an open letter to the Department of Health and Human Services, recommending that an ongoing 7-year AD prevention trial of two non-steroidal anti-inflammatory drugs be suspended. The letter charged that the drugs tested in this multi-center trial, naproxen and celecoxib, had insufficient scientific support and that the informed consent document used to enroll trial participants was inadequate. (See at http://www.citizen.org/publications/release.cfm?ID=7195.)
The Alzheimer Research Forum interviewed the study’s principal investigator, John Breitner of University of Washington, Seattle, about the issues underlying this letter. The Breitner Q&A and comments from 11 other scientists in the field appear below.-Gabrielle Strobel.
ADAPT: Read the Official Response from NIA (.pdf) to Government Watchdog Group
- Stockholm: Bad News Official: The Rofecoxib and Naproxen Clinical Trial Has Failed
- Stockholm: Not All NSAIDs Are Equally Good When it Comes to Alzheimer’s
- Early Clinical Results of Cox 2 Inhibitor: No Pain, No Gain?
- Large Prospective Study Finds NSAIDs Reduce Risk of Developing AD
- Anti-inflammatory Drugs Side-Step COX Cascade to Target Aβ