Clinical Outcome Assessments in Early-stage Alzheimer’s Disease Clinical Trials

Life Sciences, Clinical Trials, Drug Discovery & Development,
  • Friday, September 10, 2021

Advancing signal detection and data quality through enhanced eCOA instruments and innovative approaches to rater training and monitoring   

Studies of investigational drugs targeting the dementia stage of Alzheimer’s disease (AD) have used a co-primary approach to assess cognitive and functional (or global) measures. This approach ensured both a clinically meaningful effect by a demonstration of benefit on the functional measure and that the observed functional benefit was accompanied by an effect on the core symptoms of the disease as measured by the cognitive assessment.

As the scientific understanding of AD has evolved, enrollment of patients with AD at earlier stages where there may be no functional impairment or even no detectable clinical abnormality has become possible, as it is desirable to delay or halt disease at the earliest opportunity. Such clinical trials necessitate the use of different clinical assessments to select trial participants and/or novel endpoints to demonstrate treatment benefit, including single primary endpoints based on cognitive assessment alone.

Register for this webinar to hear three experts describe the identification and selection of clinical outcome assessments and endpoints for early (clinical stages 1 to 3) clinical trials in AD and outline strategies for optimizing their implementation through enhanced eCOA and innovative data quality programs.

Speakers

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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 Principle Scientist at Roche, Senior Clinical Lead at Bracket/UBC, and Scientific Director at Cognitive Drug Research Ltd.

Message Presenter
http://Edward%20Bartolic,%20Cogstate

Edward Bartolic, PhD, Senior Director, Clinical Science, Cogstate

Dr. Bartolic is a clinical neuropsychologist with 20 years of postdoctoral clinical research experience. Nearly 15 of those years have been in various scientific positions within global contract research organizations, including the Director of CNS Research and Scientific Director for the Rater Training Services department at i3 Research and Director of Clinical Assessment Technologies at Worldwide Clinical Trials. In his roles with rater training groups, Dr. Bartolic functioned as clinical/therapeutic lead, providing oversight of the development and management of global rater training and data monitoring/rater surveillance programs for studies in psychiatry and neurology.

He has served as lead rater trainer at numerous investigators meetings for studies in indications that include Alzheimer’s disease (AD), mild cognitive impairment (MCI)/prodromal AD, multiple sclerosis, major depressive disorder, bipolar disorder-mania, bipolar depression, schizophrenia, and generalized anxiety disorder. He has designed customized methodologies for remote monitoring of clinical trial assessments, including review of source documentation and assessment results for verification of study eligibility criteria during the screening period and confirmation of proper administration and scoring of cognitive and other neurobehavioral assessments. He also has the unique experience of having coordinated and managed two different committees consisting of independent clinical neurologists and geriatric psychiatrists responsible for adjudicating investigator-determined progression to AD endpoints in prodromal AD/MCI trials. Dr. Bartolic graduated from the University of Cincinnati with a Ph.D. in Clinical Psychology and specialization in Neuropsychology.

Message Presenter
http://Rinah%20Yamamoto,%20Clinical%20Ink

Rinah Yamamoto, PhD, Principal Scientist, Clinical Ink

Dr. Yamamoto brings more than 20 years of research experience in the pre-clinical and clinical environments. She has been involved in outcomes science for the past 5 years and has experience administering, scoring and training on clinical assessments for clinical trials. Prior to joining Clinical Ink, Dr. Yamamoto specialized in COAs, rater training development and delivery, statistical analysis and consulting on eCOA. She holds a PhD in experimental psychology from Tufts University, followed by a research position at McLean Hospital focusing on using fMRI to understand substance use and abuse and the evaluation of a novel low field magnetic stimulation treatment for bipolar and unipolar depression.

Message Presenter

Who Should Attend?

Executives, directors, scientists and managers from pharma, biotech and CROs responsible for the clinical development of Alzheimer’s disease therapeutics, including:

  • Research and Development
  • Clinical Operations
  • Clinical Science
  • Outcomes Research
  • Outsourcing and Procurement
  • Project Management
  • Clinical Trial Planning and Optimization
  • Medical Affairs

What You Will Learn

  • Overview of clinical staging as defined by the NIA-AA Research Framework and FDA early AD draft guidance: considerations for the selection, development, and application of cognitive batteries in early-stage disease – both scientific and operational.
  • Current endpoints and key challenges to data quality that can be mitigated by the use of eCOA, training and monitoring
  • Developing enhanced eCOA instruments to prevent common scoring and administration errors: case examples from the RBANS, MMSE  and CDR
  • Delivering training and certification programs and risk-based central monitoring strategies to ensure endpoint 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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