The PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults (PREVENTABLE) clinical trial is aimed at understanding the benefits of statin drugs in preventing dementia, disability or heart disease in adults over 75. A statin is a medication commonly used to lower cholesterol and prescribed to individuals with a history of heart attack and stroke. Currently, statins are not routinely recommended for prevention in adults over 75 with this history.
Funded by the National Institute on Aging (NIA) and the National Heart Lung Blood Institute (NHLBI), it is one of the largest clinical trials in adults 75 and older.
Dr. Faina Caplan, geriatrician at WellSpan Geriatrics in York, and Erica Zahos, research nurse, have enrolled 59 participants in the national trial since last summer. WellSpan is currently a top enrollment site for the trial, which recently celebrated enrolling the 10,000th participant. This is a big milestone in any clinical trial.
“When individuals sign up, they’re very interested in addressing the issues surrounding dementia, whether they’ve been affected by it directly or just want to help with the research,” said Erica. “They want to do something positive for such a negative disease.”
The national trial began in 2020, with recruitment sites located at Duke Health, Johns Hopkins and other healthcare systems. Enrollment for the trial was recently extended until 2027 with the hope of reaching at least 14,000 participants. The trial will conclude in 2030.
Erica and Dr. Caplan manage WellSpan’s recruitment site by sharing information to eligible patients through the MyWellSpan portal and following up if individuals express interest. The entire trial is conducted remotely and easily accessible, with cognition tests completed over the phone and medication shipped to the participants’ homes every three months. Erica and Dr. Caplan follow up with participants for any medical questions related to the study or study drug.
The study is a double-blind placebo-controlled trial, meaning that the participant and research team aren’t aware of the specific medication each individual receives. Some will receive a placebo, or a treatment that appears real but is designed for a clinical trial and has no benefits, and some will receive an active drug – Atorvastatin. The placebo and Atorvastatin are labeled as “study drug” and entered into the participants active medication list.
The goal of the study is to determine if statins are protective and can reduce the chance of dementia later in life. However, if the result of the study is negative, it will also be informative – concluding that the addition of a statin to an older individual’s medication list will not reduce the risk of developing dementia.
At this time, no results from the trial have been shared. However, Erica and Dr. Caplan hope to hear feedback regarding participants reaching the five-year mark in the trial as they attend an annual meeting this December.
“As a geriatrician, I’m hoping that this trial opens doors with how we can help patients,” said Dr. Caplan. “While we may not feel like we are moving mountains in our small cohort at WellSpan, this study has great implications for our aging population.”
Learn more about the trial here.
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