PREVENTABLE Trial Implementation Phase

ABSTRACT - Trial Implementation
PREVENTABLE (PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults) will
determine the effect of a moderate intensity statin on new dementia and disability-free survival in 20,000
community-dwelling participants age ≥75 years without atherosclerotic coronary heart disease or dementia. In
addition, we will test the effect of a moderate intensity statin on reducing the CV composite (Hospitalization for
MI/ACS, Stroke, or HF, CV revascularization or CV death) or the cognitive composite (MCI or dementia). The
tolerability of statins will be determined by SAMS-CI, participant-report, and reason for stopping study drug.
The Trial Implementation core will be under the leadership of Drs. Karen Alexander at DCRI and Jeff
Williamson at WFSM. Together, our research team has substantial experience in pragmatic trial conduct,
seamless implementation of the protocols, clinical trials in older adults, and assessment of cognitive and
physical function. PREVENTABLE will be well positioned during trial implementation to enroll the right
population, deliver the intervention, and efficiently and completely ascertain outcomes. We will draw on
extensive and internationally recognized success in the development of study tools (CRF, ICF, manual of
operations, enrollment materials), processes (IRB approval, data transfer, biospecimen transfer),
communications (training materials, project meetings) and operational plans (data monitoring plan, site
monitoring plan, poor enrollment mitigation plans). All of these must be finalized and disseminated before study
start up. The Trial Implementation Core has the following specific aims: AIM 1. Randomize 20,000 community-
dwelling ambulatory older adults (≥ 75 years) without dementia or CVD to atorvastatin 40mg or matching
placebo. AIM 2. Deliver the intervention with a high degree of accuracy, adherence, and safety, with
contingencies for stopping or resuming study drug based over the trial. AIM 3. Pragmatically collect health
status of participants over time through linkage with EHR, Medicare, and NDI, and determine the new
occurrence of dementia, MCI, or disability.

Grant Number: 5U19AG065188-06
NIH Institute/Center: NIH
Principal Investigator: KAREN ALEXANDER