Understanding and Addressing Unique Participant and Procedural Challenge in Preclinical AD
In clinical trials of preclinical Alzheimer’s disease (AD), participant characteristics, outcome measures, assessment procedures, and the context of assessment require substantially different strategies and procedures than those applied in clinical trials of symptomatic AD. Many of the tests and scales used commonly to measure cognitive change in symptomatic AD lack the sensitivity to capture the subtle changes that can occur in preclinical AD.
New approaches to the assessment of clinical trial outcomes are required to optimize studies for detecting the earliest disease-related changes and to measure the potential benefits of treatment with new investigational drugs.
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