The views of Alzheimer disease patients and their study partners on proxy consent for clinical trial enrollment

Objective: To examine the views of Alzheimer disease (AD) patients and their study partners on the ethics of proxy consent for clinical research. Design: Cross-sectional interview. Setting: At the 13 study sites of a randomized and placebo controlled study of simvastatin for the treatment of AD. Participants: Patients with mild-to-moderate AD and their study partners enrolled in an Alzheimer's Disease Cooperative Study trial of simvastatin. Measurements: Interviews to assess how participants made the decision to enroll in a randomized controlled trial and their attitudes on proxy consent. Results: Study partners of patients judged not capable of providing informed consent reported the same degree of patient involvement in the decision to enroll as the study partners of patients capable of providing informed consent. Most study partners and patients supported proxy consent for this clinical trial and nearly all patients chose their study partner as their proxy. Study partners generally made research enrollment decisions based on what they thought would maximize the patient's well-being as opposed to a substituted judgment. Conclusions: Patients and their study partners who were enrolled in a clinical trial supported proxy consent both for themselves and as a matter of policy. Our findings suggest that policies that require substituted judgments may not accord with the views of the people currently participating in AD clinical trials.