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

Neurobiol Aging. 2016 Mar;39:147-53. doi: 10.1016/j.neurobiolaging.2015.11.007. Epub 2015 Nov 22.

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.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Alzheimer Disease / diagnostic imaging
  • Alzheimer Disease / metabolism
  • Alzheimer Disease / prevention & control*
  • Amyloidogenic Proteins / metabolism*
  • Biomarkers
  • Clinical Trials as Topic*
  • Disclosure*
  • Female
  • Humans
  • Informed Consent
  • Male
  • Patient Participation / psychology*
  • Patient Participation / statistics & numerical data*
  • Patient Selection*
  • Positron-Emission Tomography

Substances

  • Amyloidogenic Proteins
  • Biomarkers