Alzheimer’s Prevention Initiative Generation Program: Development of an APOE genetic counseling and disclosure process in the context of clinical trials
Langlois, Carolyn M.; Bradbury, Angela; Wood, Elisabeth M.; Roberts, J. Scott; Kim, Scott Y.H.; Riviere, Marie‐emmanuelle; Liu, Fonda; Reiman, Eric M.; Tariot, Pierre N.; Karlawish, Jason; Langbaum, Jessica B.
2019
Citation
Langlois, Carolyn M.; Bradbury, Angela; Wood, Elisabeth M.; Roberts, J. Scott; Kim, Scott Y.H.; Riviere, Marie‐emmanuelle ; Liu, Fonda; Reiman, Eric M.; Tariot, Pierre N.; Karlawish, Jason; Langbaum, Jessica B. (2019). "Alzheimer’s Prevention Initiative Generation Program: Development of an APOE genetic counseling and disclosure process in the context of clinical trials." Alzheimer’s & Dementia: Translational Research & Clinical Interventions 5(C): 705-716.
Abstract
IntroductionAs the number of Alzheimer’s disease (AD) prevention studies grows, many individuals will need to learn their genetic and/or biomarker risk for the disease to determine trial eligibility. An alternative to traditional models of genetic counseling and disclosure is needed to provide comprehensive standardized counseling and disclosure of apolipoprotein E (APOE) results efficiently, safely, and effectively in the context of AD prevention trials.MethodsA multidisciplinary Genetic Testing, Counseling, and Disclosure Committee was established and charged with operationalizing the Alzheimer’s Prevention Initiative (API) Genetic Counseling and Disclosure Process for use in the API Generation Program trials. The objective was to provide consistent information to research participants before and during the APOE counseling and disclosure session using standardized educational and session materials.ResultsThe Genetic Testing, Counseling, and Disclosure Committee created a process consisting of eight components: requirements of APOE testing and reports, psychological readiness assessment, determination of AD risk estimates, guidance for identifying providers of disclosure, predisclosure education, APOE counseling and disclosure session materials, APOE counseling and disclosure session flow, and assessing APOE disclosure impact.DiscussionThe API Genetic Counseling and Disclosure Process provides a framework for largeâ scale disclosure of APOE genotype results to study participants and serves as a model for disclosure of biomarker results. The process provides education to participants about the meaning and implication(s) of their APOE results while also incorporating a comprehensive assessment of disclosure impact. Data assessing participant safety and psychological wellâ being before and after APOE disclosure are still being collected and will be presented in a future publication.Highlightsâ ¢Participants may need to learn their risk for Alzheimer’s disease to enroll in studies.â ¢Alternatives to traditional models of apolipoprotein E counseling and disclosure are needed.â ¢An alternative process was developed by the Alzheimer’s Prevention Initiative.â ¢This process has been implemented by the Alzheimer’s Prevention Initiative Generation Program.Publisher
Wiley Periodicals, Inc. US Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation
ISSN
2352-8737 2352-8737
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