Challenges and Opportunities to Conduct Global Alzheimer’s Disease Clinical Trials

Toward the right treatment at the right time: Modeling the trajectory of cognitive decline to identify the earliest age of change in people with Alzheimer's disease

“…Previous authors have suggested one of the reasons RCTs in AD have been largely unsuccessful is because of poor trial design. 28 There has been substantial work on methods to improve RCT design including research on participants' priorities to increase willingness to participate in RCTs, 29 suggestions to use Bayesian adaptive RCT designs, 30 and using polygenic hazard scores to stratify participants. 31 However, limited consideration has been given to the age of participants when they enter into an RCT and the accepted convention is to enroll partic-ipants over 50, 60, or 65 years to 85 years old depending on the target population, study aims or choice of outcome measure.…”

“…RCTs which are more selective in the age range of participants and recruit participants when they exhibit the earliest signs of decline could potentially improve the success of DMT by intervening earlier in the disease stage. This approach could also help to provide better data related to treatment efficacy, 30 which is currently lacking in the literature. Several authors have made recommendations for earlier detection to be utilized in RCTs to optimize intervention windows 11,34 .…”