Improving endpoint selection in Alzheimer’s disease trials

This panel of neurologists and biostatisticians will discuss their thoughts on how we advance development for the first disease-modifying digital therapeutics in Alzheimer’s disease. Learn about the current and innovative new endpoints for Alzheimer’s disease. What biomarkers of physiological change can be used to demonstrate change of disease progression and disease modification? Learn from leading experts in neuroscience and clinical study design as they discuss emerging trends and the current therapeutic landscape in Alzheimer’s disease.

Attendees will learn:
  • Definition of disease-modifying clinical measures and outcomes in Alzheimer’s disease
  • Challenges with traditional clinical endpoints in Alzheimer’s studies
  • Which study endpoints are emerging in Alzheimer’s disease modification trials
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Michael Yassa

Michael Yassa, PhD

Director, UCI Brain Initiative & Center for the Neurobiology of Learning and Memory

Dr. Michael Yassa is a Professor of Neurobiology, Neurology and Psychiatry at the University of California, Irvine. He currently serves as Associate Dean in the School of Biological Sciences, Director of the campus-wide UCI Brain Initiative, and Co-Director of the globally renowned Center for the Neurobiology of Learning and Memory. Dr. Yassa’s laboratory is interested in how the brain learns and remembers information, and how learning and memory mechanisms are altered in aging and neuropsychiatric disease. The central questions in the lab's research are: (1) What are the neural mechanisms that support learning and memory? (2) How are memory circuits and pathways altered in the course of aging, dementia, and neuropsychiatric disorders such as depression and anxiety? and (3) How can we identify early preclinical biomarkers that can distinguish between normal and pathological neurocognitive changes so that we can better design diagnostic and therapeutic tools. To address these questions, the Yassa lab develops and refines cognitive assessment tools that can be used as outcome measures in clinical trials in neurodegenerative and neuropsychiatric indications. The team also develops, optimizes, and uses a host of advanced brain measurement techniques including high-resolution structural, functional, and diffusion MRI, PET, EEG, and intracranial recordings (ECoG) in patients, to explore the brain’s architecture at very fine levels of detail and develop actionable biomarkers for disease processes that can be used for early diagnosis and targeted treatment.

Suzanne Hendrix

Suzanne Hendrix, PhD

CEO, Pentara Corporation

Suzanne Hendrix is CEO of Pentara Corporation, a boutique CRO in Salt Lake City, Utah, USA specializing in statistics and data management in neurodegenerative diseases. Pentara has supported the study design, data collection and analysis of over 50 clinical trials since 2008. Pentara’s clients include small, medium and large pharmaceutical companies, non-profit groups and academic groups in all phases of development. Pentara has expertise in CDISC standards, statistical genetics, biomarker analysis, Bayesian statistics, machine learning techniques and artificial intelligence.

Suzanne received her PhD from Boston University and has over 30 years of clinical trials experience with time spent at CROs and pharmaceutical companies, including projects across many disease areas including respiratory, oncology, reproductive, and cardiovascular. She has been instrumental in analysis and reporting for multiple regulatory submissions including NDAs, PLAs, and ISS/ISE documents.

Suzanne has first authored or co-authored over 150 peer-reviewed publications related to both clinical trial results and statistical approaches for clinical trials, most of which relate to analysis and design of trials for neurodegenerative diseases. She has extensive experience in optimally measuring progression over time and identifying outcomes that are likely to be sensitive to effects due to treatments that modify important aspects of the disease.

Allan Levey, MD PhD

Allan Levey, MD PhD

Professor and Chairman, Department of Neurology, Emory University

Dr. Levey is Professor and Chairman of the Department of Neurology at Emory University, and he is Director of the Emory Alzheimer’s Disease Research Center. Dr. Levey has secondary faculty appointments in the Departments of Pharmacology and Psychiatry and Behavioral Sciences.

Dr. Levey received a BS from the University of Michigan and an MD and PhD (Immunology) from the University of Chicago. He then trained in Neurology at Johns Hopkins, molecular biology at the National Institutes of Health, and then joined the Johns Hopkins faculty in the Departments of Neurology & Pathology. Dr. Levey has been at Emory University since 1991, where he has held a number of positions, including Director of Graduate Studies for the Neuroscience PhD Program, Founding Director of the Emory Center for Neurodegenerative Disease, and Director of the Emory MD/PhD Training Program. He is one of the leaders of the Emory Healthy Aging Study, the largest clinical research study in Atlanta.

Dr. Levey is a neurologist and neuroscientist internationally recognized for his work in neurodegenerative disease. He has more than 270 research publications. His work has contributed to understanding the brain systems and mechanisms involved in neurodegenerative disorders including Alzheimer’s and Parkinson’s diseases and in identifying molecular targets for new therapeutic strategies. He has received several awards including the Derek Denny-Brown Neurological Scholar Award from the American Neurological Association, the Heikkila Research Scholar Award from the National Parkinson Foundation, the Health Advancement Research Award from Community Health Charities, the Team Hope Award for Medical Leadership from the Huntington’s Disease Society of America, and he was inducted into the Johns Hopkins Society of Scholars. Dr. Levey was also named an ISI Highly Cited Researcher in the field of Neuroscience and has consistently been listed among one of the Best Doctors in America.

Tom Megerian, MD PhD

Tom Megerian, MD PhD

Chief Medical Officer, Cognito Therapeutics

Dr. Tom Megerian is the Chief Medical Officer of Cognito Therapeutics. He received his training at Northwestern, earning an MD and PhD in neuroscience. He then trained in Neurology and Pediatrics, as well as a Fellowship in Behavioral Child Neurology at Boston Children's. Since then, he has worked in direct patient care as a pediatric neurologist as well as in clinical and operational roles at therapeutics development companies for neuro-related therapies. Most recently he has served as CMO of a pharmaceutical company, and senior executive of both medical device and pharmaceutical companies - all in the neurology space. Tom is currently a practicing neurologist at Children's Hospital Orange County (CHOC) and is currently serving as the medical director of the Autism center at CHOC. Tom has over 20 years of experience designing and executing clinical trials in neurology.