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Translating Preclinical Test Results into “Real World” Consequences

By Jalayne J. Arias, JD, MA

PhotoJalayne J. Arias is the Associate Director of the NeuroEthics Program and Assistant Professional Staff in the Department of Bioethics at the Cleveland Clinic. Ms. Arias’ work incorporates empirical and conceptual projects addressing critical legal and ethical issues inherent in diagnosing, treating, and researching Alzheimer’s disease and other neurodegenerative conditions. Most recently, she served as the principal investigator for the study Stakeholders’ Perspectives on Preclinical Alzheimer’s Diagnosis: Patients, Families and Care Givers. Her recent publication, Confidentiality in preclinical Alzheimer disease studies (Neurology), addresses confidentiality concerns relevant to biomarker testing in Alzheimer’s.

In 2007, Dr. Dubois and co-authors introduced the concept of prodromal Alzheimer’s disease in their Lancet article revising diagnostic criteria. In 2011, the National Institutes of Aging and the Alzheimer’s Association supported a series of papers introducing a new paradigm for diagnostic criteria, including Mild Cognitive Impairment and preclinical Alzheimer’s disease. Both papers and new definitions of Alzheimer’s disease incorporate the discovery of Amyloid beta, a biomarker that purports to indicate disease pathology. The concept of using biomarkers, which are detectible years before a patient begins experiencing symptoms, offers the potential for offering preclinical testing in the clinical context. Yet, as researchers continue to validate biomarkers, little is known about how preclinical test results may affect patients and their families.

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