Bringing the Clinical Trial to the Patient in Preclinical Alzheimer’s Disease

With the first demonstration that anti-amyloid therapies can slow amyloid accumulation and reduce clinical disease progression in symptomatic Alzheimer’s disease, there is increasing focus on the extent to which disease modifying therapies, applied very early in AD, may delay symptom onset itself.

With focus turning to clinical trials in the preclinical stage of Alzheimer’s disease, clinical trial design is faced with new challenges and new opportunities. The requirement for identifying abnormal Alzheimer’s disease biology in cognitively unimpaired adults is being made easier with the industrialization of blood-based biomarkers for amyloid and tau. In the same vein, engaging, screening, recruiting and even assessing clinical status in cognitively unimpaired adults is facilitated through use of remote clinical assessment.

Clinical trial teams now need testing solutions that are effective and equivalent when deployed outside of the clinical site. Utilizing remote testing allows participants to be assessed from the comfort of their home, typically reducing the number of site visits, and supporting faster and more diverse recruitment which allows studies to be extended to include samples from underrepresented populations.

Cogstate technologies have been used in remote contexts in clinical trials and research for decades. This experience provides the basis for their current application in Phase III registration of trials of disease-modifying therapies in preclinical Alzheimer’s disease.

This webinar will consider the types of remote cognitive assessments that can be applied in clinical trials, aspects of trial design to which they apply and the methodological issues that require consideration when cognitive assessments are conducted remotely. The featured speakers conclude with consideration for the potential opportunities afforded by use of remote cognitive assessment in preclinical Alzheimer’s disease.

Speakers

Paul Maruff, PhD, Chief Innovation Officer, Cogstate

Professor Paul Maruff is one of the founders of Cogstate and served as Chief Science Officer before taking on the role of Chief Innovation Officer. He is a neuropsychologist with expertise in the identification and measurement of subtle behavioral and cognitive dysfunction. Paul’s research integrates conventional and computerized neuropsychological testing with cognitive neuroscientific methods to guide decision making in drug development and in clinical medicine. Paul remains an active researcher. He is the appointed Professor at the Florey Institute for Neuroscience and Mental Health and the current clinical Co-Chair of the Australian Imaging Biomakers and Lifestyle (AIBL) study. Paul has published over 450 research articles in international peer-reviewed scientific journals and has co-authored 15 book chapters.

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Chris Edgar, PhD, Chief Science Officer, Cogstate

Dr. Chris Edgar is an experienced leader in cognitive assessment and clinical endpoint strategy who provides expert guidance to Cogstate’s pharmaceutical customers throughout all stages of trial conduct, from study design and test selection through final analysis. Prior to joining Cogstate, Dr. Edgar oversaw clinical endpoint strategy for multiple neuroscience indications in the Patient-Centered Outcomes Research group at Roche. He holds a PhD in psychopharmacology from Northumbria University and has 20 years of pharmaceutical industry experience. Dr. Edgar has held other key industry positions including Principal Scientist at Roche, Senior Clinical Lead at Bracket/UBC and Scientific Director at Cognitive Drug Research Ltd.

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