For any new Alzheimer’s disease drug to achieve FDA approval and widespread clinical use, it must be tested in human beings and demonstrated as both safe and efficacious. Studies to test the safety and efficacy of new treatments are called clinical trials. Clinical testing now represents the most costly and difficult phase of developing improved therapies. A major challenge of completing human clinical trials is the timely enrollment of participants who will enable adequate examination of therapeutic hypotheses. Alzheimer’s disease clinical trials now enroll people with Alzheimer’s dementia, people with mild cognitive impairment, and people with healthy memories but who are at increased risk to some day develop dementia. We are engaged in a variety of studies that aim to
• Identify means to improve Alzheimer’s disease clinical trial designs to enable adequate testing in fewer participants,
• Elucidate barriers to clinical trial enrollment in each Alzheimer’s disease population, so that trials and recruitment campaigns can be designed in a manner that maximizes the speed of accrual,
• Understand better which participants are at risk to be lost to follow-up, to guide clinician scientists when enrolling participants in Alzheimer’s disease trials, and
• Investigate the ethical challenges in clinical trials, especially those related to Alzheimer’s disease disclosure, including the disclosure of diagnosis, biomarker results, and genetic testing.