As the quest to understand Alzheimer’s disease (AD) and develop biomarkers and disease modifying treatments continues, there remains great need to provide effective treatment for those living with the disease today. Growing evidence suggests lifestyle changes are a key component for meeting this dire need as the population with AD continues to grow. Much remains to be learned, however, regarding which lifestyle interventions and in what quantities will be effective.
The Alzheimer’s Association funded and recently launched US POINTER study (NCT03688126) aims to provide data that will help answer these questions. The study plan is to enroll 2,000 participants, age 60 to 79, who will be randomly assigned to receive a specific structured program of exercise and other healthy lifestyle activities or a self-designed program fitting healthy lifestyle activities into their own existing routines. All participants will be encouraged to follow a healthy diet and increase physical and cognitive activity.
The primary outcome is the 2-year cognitive trajectory using a global composite score designed to match similar studies around the globe, potentially allowing for both pooled and subgroup data analysis across a diverse population. Intervention effects on vascular and metabolic health, physical function, mood, sleep, healthcare utilization and quality of life will also be assessed. Evaluators will be blinded to the participants group assignment and intervention.
Maria C. Carrillo, PhD, Alzheimer’s Association chief science officer and investigator on the study said, “We envision a future where we can treat and even prevent Alzheimer’s through a combination of brain-healthy lifestyle and targeted medicines, as we do now with heart disease.”
Study centers are in Wake Forest School of Medicine, Winston-Salem, NC; University of California-Davis, Davis, CA; Rush University Medical Center, Chicago, IL; Baylor College of Medicine, Kelsey Research Foundation and the Houston and Southeast Chapter of the Alzheimer’s Association in Houston, TX; and another site still to be named.
“US POINTER provides an unprecedented opportunity to test whether intensive lifestyle modification can protect cognitive function in older Americans who are at increased risk of cognitive decline and dementia,” said Laura Baker, PhD associate professor of gerontology and geriatric medicine at Wake Forest School of Medicine, and a principal investigator on the study.