Background: Drug development for disease modifying agents in Alzheimer’s disease (AD) is focused increasingly on targeting underlying pathology in very early stages of AD or in cognitively normal patients at elevated risk of developing dementia due to Alzheimer’s. Very early interventional studies of this type have many uncertainties, including whether they can provide the clinical results that payers, providers, and patients will wish to see for decisions. This paper describes an initiative to create greater transparency for researchers to anticipate these decision needs.

Objective: to create multi-stakeholder–vetted recommendations for the design of studies in later phases of drug development to evaluate the ability of disease modifying agents to delay or prevent the onset of dementia due to Alzheimer’s disease (AD).

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(1) D.A. Messner, P. Rabins, A.C. Downing, M. Irizarry, N.L. Foster, J. Al Naber, O. Dabbous, H. Fillit, S. Gabler, H. Fillit, S. Gabler, R. Krakauer, D. Lotz, E. Payzant, L. Schneider, J. Tyrone, D. Van Amerongen, D. Wuest J Prev Alz Dis 2019;6(1):20-26

Article DA. Messner