Advancing Alzheimer’s Clinical Trial Endpoints: Imaging Biomarkers, COA Challenges, Movement Measures, and CV Risk
11am ET / 4pm BST / 5pm CEST
Join us for this webinar which explores the critical aspects of conducting clinical trials in Alzheimer’s disease (AD) with a focus on innovative methodologies and challenges encountered. We will review the pivotal role of imaging biomarkers in characterizing patient eligibility, ensuring safety and evaluating therapeutic efficacy in AD trials. Next, we will discuss the evolving landscape and challenges associated with collecting endpoints for clinical outcome assessments (COAs) in a changing patient population. From there we will discuss the potential of leveraging gait and balance measures for detection and diagnosis of cognitive impairment and dementia and their significance in early intervention. Finally, we review the complexities of running trials in populations at high risk for cardiovascular (CV) disease, emphasizing the importance of baseline testing regardless of the drug being investigated. This webinar will provide insights that can inform sponsors to enhance the design and execution of AD clinical trials.
Attendees will learn about:
- The role of imaging biomarkers for characterizing patient eligibility, safety and therapeutic efficacy in AD clinical trials
- Challenges of the patient population and the changing landscape related to the collection of endpoints for COAs
- Potential of leveraging gait and balance measures for the detection and diagnosis of cognitive impairment and dementia
- Complexities of running a trial in a population at high risk for CV disease independent of the asset and the importance of having sufficient baseline testing in this situation
Moderator
Todd Rudo, M.D.
Chief Medical Officer at Clario
Dr. Todd Rudo is EVP and Chief Medical Officer at Clario, providing medical and scientific leadership across the organization. He has nearly 20 years of clinical cardiology and pharmaceutical research experience, with a career predominantly focused on drug safety. Dr. Rudo has board certifications in cardiology, cardiac electrophysiology, nuclear cardiology, adult echocardiography and internal medicine. His team provides expert consulting to clients on scientific and regulatory strategy, and ensures Clario’s product portfolio is scientifically robust, generating high-quality clinical trial endpoint data. Dr. Rudo has a particular interest in applying innovative technologies to improve the scientific rigor of clinical trials, while maintaining focus on the customer experience, including minimizing patient and site burden.
Speakers
Chris Conklin, Ph.D.
Director, Neuroscience at Clario
Chris Conklin is a Director specializing in MRI at Clario, providing neuroscience expertise to the Medical Imaging organization. Chris received his PhD in Electrical Engineering with a sub-specialty in Biomedical Physics. He has 10+ years of experience in MRI physics, fMRI study and protocol optimization for both cognitive and clinical pre-neurosurgical planning, various post-processing pipeline developments for quantitative analysis and academic and professional society teaching. His current area of focus includes the investigation and development of advanced diffusion imaging schemes and analytical tools for optic nerve and spinal cord functional characterization.
Prateek Verma, M.D.
Director, eCOA Science and Consulting at Clario
Dr. Prateek Verma is an MD with more than 20 years’ experience in clinical research. He has served as a clinical investigator in global neuro-psychiatry clinical trials. Dr. Verma has worked extensively in areas of AD, schizophrenia, MDD, bipolar, dementia, other behavioral disorders, infectious diseases and dermatology. Dr. Verma has also held advisory position for NIHR research design services and primary mental health clinical trials unit (PRIMENT) while working for Medical Research Council, UK and University College London. He presently oversees eCOA design, investigator training and outcome analysis activities in global psychiatric, neurology and non-CNS indications and serves as an expert presenter at global investigator meetings and mentors scientific staff.
Vic Patel, M.D., Ph.D.
Vice President and Chief Medical Officer, Cardiology at Clario
Dr. Vic Patel is board-certified in cardiology with a PhD in Biophysics and has done extensive research on mechanisms of cardiac arrhythmias. He was on the faculty at Perelman School of Medicine at the University of Pennsylvania for 11 years where he directed molecular arrhythmia research and practiced clinical electrophysiology. Dr. Patel then moved into drug development and cardiac safety as a clinical development leader and therapy area head across all phases. At Clario, Dr. Patel oversees cardiology consulting and ECG/Holter core lab services while leading the biostatistics and medical writing groups. He works with our global customers to ensure their needs are met with robust, cost-effective solutions.
Adam Jagodinksy, Ph.D.
Scientific Advisor, Precision Motion at Clario
Adam Jagodinsky, Ph.D. is a scientific advisor and oncology lead on the Precision Motion Science and Consulting team where he works to advance the use of digital health technologies in clinical and academic research. Dr. Jagodinsky consults with sponsors on implementing wearable sensor solutions in clinical trials and provides comprehensive scientific support surrounding instrumented test and endpoint selection. Prior to joining Clario, Dr. Jagodinsky earned tenure in the Department of Exercise Science at Illinois State University. He has a background in biomechanics and human movement science, and his research focuses on the mechanics and control of gait and posture as well as leveraging technology for field-based human movement assessment.