Disclosure of amyloid status is not a barrier to recruitment in preclinical Alzheimer's disease clinical trials

Abstract

Preclinical Alzheimer's disease (AD) clinical trials may require participants to learn if they meet biomarker enrollment criteria. To examine whether this requirement will impact trial recruitment, we presented 132 older community volunteers who self-reported normal cognition with 1 of 2 hypothetical informed consent forms (ICFs) describing an AD prevention clinical trial. Both ICFs described amyloid Positron Emission Tomography scans. One ICF stated that scan results would not be shared with the participants (blinded enrollment); the other 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. We found no difference 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 whether to enroll. The requirement of biomarker disclosure may not slow recruitment to preclinical AD trials.

Keywords: Biomarker; Disclosure; Preclinical Alzheimer's disease; Recruitment.

Figure 1

Participant ratings of the importance of trial factors in the decision whether to enroll. The proportions participants providing each likert response are illustrated for each factor. *p<0.05 vs stated study risks; ^#p<0.05 vs requirement of a study partner; ^@p<0.05 vs study procedures.

Figure 2

Participant ratings of potential incentives for participation. The proportions of participants providing each likert response are illustrated for each potential incentive. *p<0.05 vs cognitive testing results; ^#p<0.05 vs genetic test results; ^@p<0.05 vs personal AD risk estimates; ^Ωp<0.05 vs overall study results; ^Ψp<0.05 vs personal blood test results.