PREVENTABLE Vanguard Phase

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The Vanguard phase is critical to early demonstration of successful recruitment and retention of participants, delivery of the study intervention, and ascertainment of the primary and secondary outcomes. The primary goal of the Vanguard Phase is to implement, review and refine trial processes and ensure successful enrollment to meet NIH expectations and confirm programmatic success of the trial. This trial will determine the role of a moderate-intensity statin in preventing dementia, including Alzheimer’s disease and Alzheimer’s disease-related dementias, and prolonging disability-free survival in patients 75 years and older without clinically evident coronary heart disease, including those with frailty, impaired physical function, mild cognitive impairment, polypharmacy, and multi-morbidity. A target of >90% of PCORnet and >80% of VA sites will be ready to randomize at study start with the remaining sites ready to randomize shortly thereafter. We will track the ability to recruit and retain participants who are representative of the available population. We will implement training and monitoring adapted from trials such as SPRINT, ADAPTABLE, ACCORD, WHIMS, and LIFE, to ensure successful delivery of the intervention. Of particular focus will be the operational metrics for the mail-order pharmacy, Hawthorne Effect, and video consent process. We will ascertain and/or adjudicate outcomes supported by validation studies for CV death and HFpEF. During this phase, PREVENTABLE will also carefully track early loss to follow-up, obtainable diagnoses from data marts and Medicare, and crossover rates, and refine processes to minimize risks to the study and inform any modifications. The Vanguard Phase Core will be under the leadership of Drs. Karen Alexander of DCRI and Jeff Williamson of WFSM. During this phase, we will carefully track early loss to follow-up and cross-over rates and refine processes for minimizing these when possible and make any needed modifications to the study procedures. We project 7,000 randomizations during the Vanguard phase (5,250 randomizations is the 75% milestone). Site activation and recruitment and retention benchmarks will also be vital for directing early efforts. The Vanguard phase has the following specific aims: AIM 1: Demonstrate the ability to recruit and retain participants in PREVENTABLE representative of those age≥75 years of age without CVD or dementia. AIM 2. Demonstrate the ability to deliver the intervention and ascertain outcomes with a high degree of accuracy. AIM 3: Demonstrate preserved power based on observed lost to follow up and cross over rates.