Regulatory Transformation: As Alzheimer’s Disease Science, Research and Advocacy Move Toward Earlier Detection and Intervention, How Will Researchers Adapt to this Evolution?

If realized, disease-modifying interventions targeted toward Alzheimer’s disease – treatments which actually slow or halt disease progression – would be a tremendous breakthrough for patients, family members and researchers. Research into disease-modifying interventions is increasingly targeted toward earlier stage patients. Although early intervention may offer the most promise for patients, this earlier focus creates challenges for researchers who have traditionally been asked to provide co-primary outcome measures which demonstrate both the cognitive as well as functional impacts of therapy.

In order to identify the appropriate clinical trial endpoints – those which demonstrate clinical meaningfulness of treatment effects in the earlier stages of disease – a robust dialogue between researchers, regulators, patients, and caregivers must take place.

In this session, a panel of notable researchers, informed advocates, and regulatory experts will present an overview of the current paradigm, discuss the anticipated challenges as research focuses earlier, and debate future requirements.

Moderator:

Melissa Stevens, Deputy Executive Director, FasterCures

Speakers:

Cynthia Bens, Vice President of Public Policy, Alliance for Aging Research

Richard C. Mohs, PhD, Distinguished Research Fellow, Neuroscience and Medical Research, Eli Lilly and Company

Lon S. Schneider, MD, MS, Professor, Psychiatry, Neurology, and Gerontology, USC Keck School of Medicine