Although observational studies have identified modifiable risk factors for Alzheimer’s disease and related dementias (ADRD), randomized controlled trials (RCTs) of risk factor modification for ADRD prevention have been inconsistent or inconclusive. This suggests a need to improve translation between observational studies and RCTs. However, many common features of observational studies reduce their relevance to designing related RCTs. Observational studies routinely differ from RCTs with respect to eligibility criteria, study population, length of follow-up, treatment conditions, outcomes, and effect estimates. Using the motivating example of blood pressure reduction for ADRD prevention, we illustrate the need for a tighter connection between observational studies and RCTs, discuss barriers to using typically-reported observational evidence in developing RCTs, and highlight methods that may be used to make observational research more relevant to clinical trial design. We conclude that the questions asked and answered by observational research can be made more relevant to clinical trial design, and that better use of observational data may increase the likelihood of successful, or at least definitive, trials. While we focus on improving translation of observational studies on risk factors for ADRD to RCTs in ADRD prevention, the overarching themes are broadly applicable to many areas of biomedical research.

Introduction:Ensuring adequate and equitable distribution of resources to support persons living with dementia relies on understanding the burden and distribution of dementia in a population. Our goal was to develop an approach to estimate dementia prevalence at the local level in the United States using publicly available data. Methods:Our approach combines publicly available data on dementia prevalence and demographic data from the US Census to estimate dementia prevalence. We illustrate this approach by estimating dementia prevalence in persons aged 65 and older in

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