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Speakers:
Thomas Laage, MD, MPH, Director, Product Development Consulting and Regulatory Medical Writing Support, Premier Research
Matthew T. Healy, Senior Manager, Clinical Management, Premier Research

From the imperative to detect cognitive and functional changes as early as possible in the course of Alzheimer’s disease, through the importance of measuring cognitive and attentional effects of investigational drugs in clinical trials, to the quantification of cognitive deficits during the course of affective disorders, the need for accurate, specific, and cost-effective neuropsychological assessment methods has never been greater.

This webinar will briefly review:

The evolution of neuropsychological testing
The difficulties with variability and inter-rater reliability in paper-and-pencil tests administered by raters
The limitations of traditional instruments for cognitive assessment
Regulatory requirements for clinical trial endpoints of disease-modifying therapies
The promise of computerized cognitive testing in accurately and reproducibly measuring performance while minimizing environmental and interpersonal factors of variability
Examples of computer-based cognitive tests for measuring specific endpoints
Learning Objectives

What neuropsychiatric tests are required for demonstrating safety and tolerability in neuropsychiatric clinical trials?
What cognitive and functional endpoints are relevant clinically and for regulatory purposes to demonstrate the efficacy of disease-modifying drugs in dementing illnesses like Alzheimer Disease?
What options are available and affordable in the marketplace for these purposes?

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