Lessons Learned from Failed and Discontinued Clinical Trials for the Treatment of Alzheimer's Disease: Future Directions

摘要

Abstract. While advances have been made in understanding the neurobiological processes underlying Alzheimer’s disease (AD),nfew treatment options currently exist. Numerous potential therapeutic and/or preventive agents have been tested in clinical trials,nyet most have failed to show a clear therapeutic benefit. The lack of effective medical therapies coupled with the incipient projectedndramatic increase in the number of persons with AD in the coming decades has put medical research in a crisis to urgently findneffective treatment and prevention strategies. Researchers and funding agencies have been rethinking investigative approaches innorder to accelerate scientific discovery in AD therapeutics, including methodological issues in the design and implementation ofnclinical trials. This review discusses lessons learned from discontinued and failed clinical trials for the treatment and preventionnof AD with an emphasis on future directions of AD clinical trials. In particular, attention is given to choice of study outcomenmeasures, participant selection and retention, and clinical trial design. While there are few treatments available for AD currently,nthe potential for discovery over the next decade is promising