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Diagnosing Early Stage “Pre-clinical” Alzheimer’s Disease- Clinical Advances & Ethical Considerations
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Kathleen A. Welsh-Bohmer, PhD
Professor, Departments of Psychiatry and Neurology
Duke University Health System
Director of Alzheimer’s Disease Interventional Trials
Duke Clinical Research Institute (DCRI)
& VP for Neurodegenerative Disorders at VeraSci
Credit
CE:1.0

Description
Progress in understanding the biological expression of Alzheimer’s disease (AD) has led to the recent revision of the diagnostic criteria for the disease, which is defined by the biology present and, to a far lesser extent, the clinical phenomenology. These criteria recognize the full disease continuum and invite the possibility of arriving at an early diagnosis of AD when the condition is clinically silent and potentially at a point in the disease many years in advance of the emergence of any symptoms. Absent any effective treatment for either preventing the disease onset or slowing its rate of progression, a diagnosis of biomarker-determined preclinical (silent) AD poses a number of ethical considerations for the practicing clinician. In this session, we will: 1) review the recent advances in AD biomarkers and their implications for diagnosis and treatment; 2) consider the ethical issues that arise from an early diagnosis, including both the merits of early detection and the risks of having a diagnosis before symptoms have manifested; and, 3) conclude by discussing the implications of a biological diagnosis of AD for the practice of clinical neuropsychology, including the types of referral questions we might expect, the impact on our inferential approach, and the normative data we select.
Dr. Kathleen Welsh-Bohmer is a Professor of Psychiatry and Neurology at Duke University. Clinically trained as a neuropsychologist, her research activities have been focused around developing effective prevention and treatment strategies to delay the onset of cognitive disorders occurring in later life. She was the Principal Investigator of the Cache County Memory Study (2002-2013), an epidemiological study of an exceptionally long-lived population that established key environmental modifiers affecting Alzheimer’s disease onset and progression. Since 2006 she has directed the Joseph and Kathleen Bryan Alzheimer’s Center at Duke University, where she has led a large multidisciplinary team focused around the genetic determinants of Alzheimer’s disease and speeding drug discoveries to prevent and treat neurodegenerative diseases. She has served as the neuropsychology lead for the TOMMORROW program, a global clinical trial to delay the onset of mild cognitive impairment due to Alzheimer’s disease (Takeda Pharmaceutical Company). And very recently, she was appointed to the Duke Clinical Research Institute (DCRI), an academic clinical research organization, to oversee its interventional trials within the Alzheimer’s disease therapeutic area. Concurrently, she is leading science strategy for neurodegenerative disorders in VeraSci, a private company focused on improving the precision of endpoint measurements within clinical trial designs. The methods her team has been developing in collaboration with public and private partners help fill an information void in the measurement of preclinical dementias and has important implications for accelerating global clinical trials in Alzheimer’s disease prevention and in population health.
After the session, participants will be able to:
- Define the biomarkers used in diagnosing Alzheimer’s disease.
- Explain the difference between diagnostic biomarkers and surrogate markers for measuring response to treatment.
- Describe the ethical issues associated with an early biological diagnosis of Alzheimer’s disease.
- Explain the impact of knowledge of AD biomarkers status on cognitive performance and psychological health.
- List the types of referral questions clinical neuropsychologists can expect in the context of biologically defined Alzheimer’s disease.
- Discuss the influences of AD biomarkers when drawing clinical inferences about normal or abnormal function.
Target Audience: Neuropsychologists and trainees
Instructional Level: Intermediate
Dr. Kathleen Welsh-Bohmer is a Professor of Psychiatry and Neurology at Duke University. Clinically trained as a neuropsychologist, her research activities have been focused around developing effective prevention and treatment strategies to delay the onset of cognitive disorders occurring in later life. She was the Principal Investigator of the Cache County Memory Study (2002-2013), an epidemiological study of an exceptionally long-lived population that established key environmental modifiers affecting Alzheimer’s disease onset and progression. Since 2006 she has directed the Joseph and Kathleen Bryan Alzheimer’s Center at Duke University, where she has led a large multidisciplinary team focused around the genetic determinants of Alzheimer’s disease and speeding drug discoveries to prevent and treat neurodegenerative diseases. She has served as the neuropsychology lead for the TOMMORROW program, a global clinical trial to delay the onset of mild cognitive impairment due to Alzheimer’s disease (Takeda Pharmaceutical Company). And very recently, she was appointed to the Duke Clinical Research Institute (DCRI), an academic clinical research organization, to oversee its interventional trials within the Alzheimer’s disease therapeutic area. Concurrently, she is leading science strategy for neurodegenerative disorders in VeraSci, a private company focused on improving the precision of endpoint measurements within clinical trial designs. The methods her team has been developing in collaboration with public and private partners help fill an information void in the measurement of preclinical dementias and has important implications for accelerating global clinical trials in Alzheimer’s disease prevention and in population health.