Document Type
Article
Publication Date
12-9-2014
Abstract
Introduction Conventional multisession genetic counseling is currently recommended when disclosing apolipoprotein E (APOE) genotype for the risk of Alzheimer's disease (AD) in cognitively normal individuals. The objective of this study was to evaluate the safety of brief disclosure protocols for disclosing APOE genotype for the risk of AD. Methods A randomized, multicenter noninferiority trial was conducted at four sites. Participants were asymptomatic adults having a first-degree relative with AD. A standard disclosure protocol by genetic counselors (SP-GC) was compared with condensed protocols, with disclosures by genetic counselors (CP-GC) and by physicians (CP-MD). Preplanned co-primary outcomes were anxiety and depression scales 12 months after disclosure. Results Three hundred and forty-three adults (mean age 58.3, range 33-86 years, 71% female, 23% African American) were randomly assigned to the SP-GC protocol (n = 115), CP-GC protocol (n = 116), or CP-MD protocol (n = 112). Mean postdisclosure scores on all outcomes were well below cut-offs for clinical concern across protocols. Comparing CP-GC with SP-GC, the 97.5% upper confidence limits at 12 months after disclosure on co-primary outcomes of anxiety and depression ranged from a difference of 1.2 to 2.0 in means (all P < .001 on noninferiority tests), establishing noninferiority for condensed protocols. Results were similar between European Americans and African Americans. Conclusions These data support the safety of condensed protocols for APOE disclosure for those free of severe anxiety or depression who are actively seeking such information.
Keywords
Alzheimer, apoe, genetics, genomics, personalized medicine, risk assessment
Language
English
Publication Title
Alzheimers and Dementia
Grant
AG013846
Rights
© 2015 The Alzheimer’s Association. This is the peer reviewed version of the article and may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Use of Self-Archived Versions. This article may not be enhanced, enriched or otherwise transformed into a derivative work, without express permission from Wiley or by statutory rights under applicable legislation. Copyright notices must not be removed, obscured or modified. The article must be linked to Wiley’s version of record on Wiley Online Library and any embedding, framing or otherwise making available the article or pages thereof by third parties from platforms, services and websites other than Wiley Online Library must be prohibited.
Recommended Citation
Green, R.C., Christensen, K.D., Cupples, L.A., Relkin, N.R., Whitehouse, P.J., Royal, C.D.M., Obisesan, T.O., Cook-Deegan, R., Linnenbringer, E., Butson, M.B., Fasaye, G.-A., Levinson, E., Roberts, J.S. and REVEAL Study Group (2015), A randomized noninferiority trial of condensed protocols for genetic risk disclosure of Alzheimer's disease. Alzheimer's & Dementia, 11: 1222-1230. https://doi.org/10.1016/j.jalz.2014.10.014
Manuscript Version
Accepted Manuscript