Alzheimer's disease (AD) is a common and chronic neurodegenerative dementia that affects up to 2.3 million people in the United States. In the next 30 years, this number will likely double to 4.6 million people. Extensive research efforts are underway to improve symptomatic treatments and to develop treatments that slow AD progression. But the very problems caused by AD that warrant research are also the cause of ethical challenges to doing that research. Studies of mild to moderate AD patients reveal substantial variation in their ability to participate in an informed consent. These impairments are closely associated with deficits in executive function -- the ability to organize, plan, and remain focused on a task. These ethical challenges are a particular problem in the conduct of early phase AD clinical trials designed to test the safety of a drug. Recommendations have been made that such phase I research should be restricted to AD patients who are judged competent by a qualified independent capacity assessor and that the informed consent session should use informational and educational techniques. But no published data show techniques that help an AD patient to participate in an informed consent. Our proposed research will address these problems. We will perform a randomized trial to test whether a memory and organizational aid in the form of a sheet that summarizes and simplifies a study's key-points can improve the decision-making abilities and competency of mild to early moderate AD patients. We will also examine subject satisfaction with the intervention, associations between competency and capacity and the cognitive predictors of benefiting from the aid. The results of this research will provide investigators, patients and their families, and institutional review boards a useful technique to guide the conduct of informed consent in ethically challenging AD research. The results will also begin to elucidate how experts make judgments of competency. ? ? ?
