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September 2017

I-SPY 2 Breast Cancer Trial as a Model for Innovation in Alzheimer Disease Therapies

Author Affiliations
  • 1Program for Regulatory Science & Medicine, Georgetown University, Washington, DC
  • 2VistaNova Consulting, Rye, New Hampshire
  • 3Department of Neurology, Georgetown University, Washington, DC
JAMA Neurol. 2017;74(9):1027-1028. doi:10.1001/jamaneurol.2017.1528

Alzheimer disease (AD) causes significant economic and social burdens for patients, families, and the health care system. To date, the US Food and Drug Administration (FDA) has approved few treatments for AD, and these temporarily ameliorate symptoms but do not slow, stop, or reverse disease progression.1 Meanwhile, 99.6% of AD trials conducted between 2002 and 2012 have encountered safety problems or failed to demonstrate benefit.1 In the face of these challenges, there is global interest to innovate clinical trials that enable more effective outcomes. Adaptive clinical trials for AD treatment could advance understanding of biological mechanisms and clinical progression and access regulatory review avenues such as accelerated approval. Trial innovation could also reinvigorate investment in drug development.

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