Enhancing Confidence in Alzheimer’s Disease Clinical Trial Outcomes: Composite Measures and In-Study Quality Programs

Clinical Trials, Life Sciences, Pharmaceutical, Pharmaceutical Regulation ,
  • December 11, 2014

Clinical trials targeting Alzheimer’s disease (AD) are frequently long and require raters to administer and score many instruments. Some of these instruments have complex scoring conventions which must be memorized and understood, while others have specific administration guidelines regarding the acceptability of patient prompts and other spontaneous verbal communications with subjects. Raters must be experienced with the dementia population and with the individual instruments specified for use in the protocol.

In this webinar, the challenge of and need for developing more sensitive clinical outcomes, and ensuring that they are administered and scored properly will be presented. The development of one such composite will be discussed. Additionally, real-world examples from recent and on-going AD clinical trials where data quality programs were employed will be presented.

Key Takeaways from this Webinar:

  • Fundamental challenges associated with clinical endpoints in AD trials
  • The rationale behind the development and use of composite measures
  • Which remediation techniques can improve outcomes with these endpoints

Speakers

Veronika Logovinsky, M.D., Ph.D., Executive Director, Eisai Inc., Neuroscience & General Medicine

Veronika Logovinsky has an MD and a PhD in Biophysics. She has received a B.S. degree in Applied Mathematics from Yale University, a M.A. degree in Chemical Physics from Columbia University and a combined MD/PhD degree from University of Pennsylvania. Her work in Biophysics utilized highly resolved fluorescence laser spectroscopy to study interactions of porphyrins with proteins in biologically important respiratory enzymes and to model behavior of proteins in complicated physiological systems. Following completion of the combined MD/PD program, Dr. Logovinsky underwent residency in Psychiatry at Harvard University School of Medicine and is a board certified psychiatrist with clinical experience in neuropsychiatric disorders. She is a recipient of Harvard Consolidated Department of Psychiatry DuPont-Warren fellowship and NARSAD Young Investigator Award.

For the past 13 years Dr. Logovinsky has worked in the Pharmaceutical industry and has focused on the neuroscience therapeutic area. She has been at Eisai Inc. since 2007 and has lead several large programs in Alzheimer’s disease. She is currently the global project lead for a therapeutic antibody program, BAN2401.

Dr. Logovinsky is particularly interested in innovative clinical trial design elements, including novel clinical outcomes. Within Eisai she has led the efforts on the development of ADCOMS, a clinical outcome assessment tool for early stages of AD. She has presented this work at a variety of international conferences and other forums, including AAIC, CTAD, AD/PD and Alzforum. She is a co-chair of the ADNI PPSB Clinical Endpoints Working Group, where representatives of multiple Pharmaceutical companies combine their efforts to study behavior of clinical tools in presymptomatic stages of Alzheimer’s disease. She is also actively involved with the Predementia Clinical Outcome Assessment (pCOA) project within CAMD.

David Miller, M.D., Clinical Vice President, Bracket

Dr. Miller has over 20 years of clinical, clinical research and teaching experience, primarily in the field of geriatric psychiatry. In addition to being board certified in psychiatry, he also has added qualifications in the specialty of geriatric psychiatry. After completing his 2-year fellowship in geriatric psychiatry at the University of Pennsylvania, he joined the faculty and served as an Assistant Professor of Psychiatry. Dr. Miller then went on to the University of Medicine and Dentistry of New Jersey, where he served as an Associate Professor of Psychiatry.

Prior to joining Bracket, Dr. Miller served as Chief of Geriatric Psychiatry, Medical Director of ECT, and President of the Medical Staff at Friends Hospital in Philadelphia, PA. At all of these institutions, he oversaw the education and training of medical students, residents and fellows in geriatric psychiatry, and was recognized with a departmental teaching award. Dr. Miller has served as a Principal Investigator in a number of dementia clinical trials. In addition, he has lectured locally, nationally and internationally on his dementia related research.

Since joining Bracket, Dr. Miller has consulted on multiple dementia protocols and has served as the Expert Presenter at dozens of investigators’ meetings across the globe.

Who Should Attend?

Medical/clinical personnel, executives, contract managers and project managers for pharma/biotech companies and CROs

Site investigators and raters

Academic and other parties invested in clinical trial success

Xtalks Partners

Bracket

Bracket is a Specialty Services provider dedicated to helping Pharmaceutical sponsors and contract research organizations achieve greater certainty and accurate outcomes in their clinical trials by seamlessly leveraging science, technology and operational excellence.

We offer comprehensive Endpoint Reliability™ solutions that incorporate Blinded Data Analytics, Diagnostic Solutions, Electronic Scale Administration and Collection, Audio/Video Capture and Review (VERIFIED™), and our computer-based cognitive assessment system (CDR System™). Our Trial Enhancement services include Rater Training and Certification, Scale Management, and Site Selection. In addition to our scientific expertise, Bracket offers Randomization and Trial Supply Management (Bracket RTSM) and ePRO technologies.

With comprehensive service offerings for clinical trial accuracy all under one roof, Bracket is unlike any other organization. Now companies both small and large can rely on one provider for both strategic and technological support covering every detail of their clinical trials.

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