Alzheimer's Prevention Initiative Generation Program: Development of an <i>APOE</i> genetic counseling and disclosure process in the context of clinical trials

Alzheimer's and Dementia: Translational Research and Clinical Interventions - Tập 5 - Trang 705-716 - 2019
Carolyn M. Langlois1, Angela Bradbury2, Elisabeth M. Wood2, J. Scott Roberts3, Scott Y.H. Kim4, Marie-Emmanuelle Riviere5, Fonda Liu6, Eric M. Reiman1,7,8,9,10,11, Pierre N. Tariot1, Jason Karlawish12, Jessica B. Langbaum1
1Banner Alzheimer's Institute, Phoenix, AZ, USA
2Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia, PA, USA
3Department of Health Behavior and Health Education, University of Michigan School of Public Health, Ann Arbor, MI USA
4National Institutes of Health, Bethesda, MD, USA
5Novartis Pharma AG, Basel, Switzerland
6Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
7Neurodegenerative Disease Research Center, Arizona State University, Tempe, AZ, USA
8Department of Psychiatry, University of Arizona School of Medicine – Phoenix, Phoenix, AZ, USA
9Department of Psychiatry, University of Arizona, Tucson, AZ, USA
10Neurogenomics Division, Translational Genomics Research Institute, Phoenix, AZ, USA.
11Arizona Alzheimer's Consortium, Phoenix, AZ, USA
12Departments of Medicine, Medical Ethics and Health Policy, and Neurology, University of Pennsylvania, Philadelphia, PA, USA

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AbstractIntroductionAs 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 large‐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 well‐being before and after APOE disclosure are still being collected and will be presented in a future publication.

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Alzheimer's and Dementia: Translational Research and Clinical Interventions

Tập 5

705-716

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