Disclosure of Amyloid Status Is Not a Barrier to Recruitment in Preclinical Alzheimer's Disease Clinical Trials
This study examined whether asking participants to meet biomarker criteria is a barrier to enrollment in Alzheimer’s disease prevention clinical trials. One hundred thirty-two older community volunteers who self-reported normal cognition were provided with one of two theoretical informed consent forms. One form indicated that the results of an amyloid positron emission tomography scan would not be shared with the participants (blinded enrollment). The other consent form stated that only persons with elevated amyloid would be eligible (transparent enrollment). Participants rated their likelihood of enrollment and completed an interview with a research assistant. No difference was found between the groups in willingness to participate. Study risks and the requirement of a study partner were reported as the most important factors in the decision of whether to enroll. The researchers concluded that the requirement of biomarker disclosure may not slow recruitment to preclinical Alzheimer's disease trials.
Grill JD, Zhou Y, Elashoff D, Karlawish J. Disclosure of amyloid status is not a barrier to recruitment in preclinical Alzheimer's disease clinical trials. Neurobiology of Aging 2015;39:147-53.