9th Annual Scientific Meeting: Working Options and Methods to Improve Cognitive Assessment in Clinical Trials of AD and Its Precursors

Chairs: Holly Posner, MD; Philip Harvey, PhD

Cognitive impairment is the most prominent and clinically relevant feature of Alzheimer’s disease (AD). Coupled with declining function, affected people become progressively impaired and reliant on family members. In the field of AD, clinical trials are moving toward spanning the time course of disease from pre-symptomatic (genetically determined) through mild cognitive impairment,  and definite dementia. We need more sensitive clinical trial outcomes measures to confidently determine whether our or not newly developed therapeutic innovations are effective.  As a bridge to fill the present need, multiple pharmaceutical companies have been developing new and potentially more sensitive endpoints for neuropsychological and functional outcomes within existing data. Including these familiar neuropsychological functional scales in trials gives little discomfort in the sense that it is usual practice. Acceptance by regulators is not yet known. Newer endpoints to clinical trials, both newly developed and those with long, rich histories in neuropsychology, also merit evaluation for use in the long-term.  This working will focus on defining strategies aimed toward optimizing the use of existing data when possible and looking to the future for new developments.