Accurate and reliable signal detection remains a critical challenge in Alzheimer’s disease (AD) clinical trials, particularly when targeting the preclinical phase where research teams must leverage different scales and operational approaches compared to studies of symptomatic AD.
Participants in these studies will be cognitively unimpaired or display only very subtle, prodromal cognitive changes, requiring extremely sensitive assessment instruments capable of detecting small, incremental changes over time. Furthermore, slow progression of AD necessitates longer trial duration to observe meaningful change, which increases risk for participant attrition and of inter/intra rater variability.
These realities can lead to more “noise” in trial data, potentially obscuring meaningful clinical outcomes and hindering development of novel therapeutics if effective signal detection strategies are not implemented.
In this webinar, attendees will learn tactics and hear case examples of various strategies clinical trial teams are deploying to improve data signal clarity and enhance the reliability of their study outcomes in preclinical AD. The expert speakers will describe the processes and benefits of:
- Strategic rater selection, robust qualification criteria and tailored training programs
- Central monitoring using both algorithmic, data-based review, as well as risk-based expert review of rater performance to flag errors and provide timely feedback to raters
- Remote, decentralized assessment options for preclinical populations such as central review and central rating using small groups of expert clinicians to administer/score scales remotely, enabling those sites lacking specialized raters to participate, increasing participant diversity and reducing participant burden
- eCOA form optimization to prevent common rater errors and enhance user experience for raters with effective data capture tools
The expert speakers will share first-hand experiences with the nuances of administering clinical outcome assessments to this specific patient population and provide tactics to deploy strong endpoint data quality programs for preclinical AD trials.
Register for this webinar to gain insights into how teams are overcoming the unique challenges of preclinical Alzheimer’s disease clinical trials.
Speakers
Dr. Kaycee Sink, MD, MAS, Chief Medical Officer, Cogstate
Dr. Kaycee Sink is board-certified in Internal Medicine and Geriatric Medicine with over 20 years of experience in clinical care and research in aging, Alzheimer’s disease and other neurodegenerative disorders.
She obtained her medical degree at the University of CA, San Francisco, and subsequently trained in internal medicine followed by clinical and research fellowships in geriatrics, also at UCSF.
Dr. Sink joined Cogstate from Genentech where she was Principal Medical Director in Neurodegeneration, having leadership roles in the late-stage development of several molecules being studied for Alzheimer’s disease and other neurodegenerative disorders as well as digital applications for the same.
She joined Genentech in 2017 after 13 years on faculty at Wake Forest School of Medicine, where she rose to tenured Full Professor of Medicine, Neurology and Public Health Sciences. At Wake Forest School of Medicine, Kaycee served as interim Chief of Geriatrics, the Director of the Memory Assessment Clinic and was the PI of the Clinical Core for the NIH funded Alzheimer’s Disease Center as well as an investigator/PI on multiple NIH and industry sponsored clinical trials in aging and Alzheimer’s disease.
Message Presenter
Dr. Svenja Wacker, PhD, Neuropsychology Science Director, Cogstate
Dr. Svenja Wacker is a licensed, clinical neuropsychologist specializing in business development for global clinical trials, bridging cognitive science and business strategy collaborating with pharmaceutical and biotech companies to optimize trial strategy, implement innovative assessment solutions optimized trial strategy and improve delivery of clinical, diagnostic tools for CNS diseases.
Dr. Wacker’s clinical trial activities are grounded in a solid foundation of hands-on clinical work. She has provided neuropsychological assessments and interventions to patients with CNS diseases and injuries and their families to guide them toward resilience and empowerment. This clinical expertise informs her strategic approach to clinical trials, ensuring that patient-centric and scientifically rigorous solutions are integrated into all phases of research.
Dr. Wacker holds a PhD in clinical psychology from George Mason University and completed a clinical neuropsychology fellowship at Yale University School of Medicine. She further honed her skills through a postdoctoral residency in neuropsychological assessment at Harvard Medical School.
Message PresenterWho Should Attend?
This webinar will appeal to Executives, Directors, Scientists and Managers from pharma, biotech and CROs responsible for global Alzheimer’s Disease clinical trials, including:
- Clinical operations
- Clinical science
- Clinical trial planning and optimization
- Medical Affairs
- Outcomes research
- Outsourcing and procurement
- Project management
- Research and development
What You Will Learn
Attendees will learn about:
- Guidance on strategic rater selection, qualification and tailored training programs
- Methods for effective central monitoring via algorithmic, data-based review and risk-based expert review
- Considerations for decentralized testing options to reduce site and patient burden and optimize data quality
Xtalks Partner
Cogstate
Cogstate Ltd (ASX:CGS) is a leading science and technology solutions provider dedicated to optimizing the measurement of cognition in clinical trials, academic research and healthcare. Cogstate provides enabling technologies and professional services for higher quality neuropsychological assessments and is a pioneer in commercializing rapid, reliable and highly sensitive computerized cognitive tests. Cogstate customers include the world’s leading biopharmaceutical companies; elite sporting organizations and military; physicians and patients; renowned academic institutions and public-private partnerships. For more information, please visit www.cogstate.com.
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