A research article published in the journal Alzheimer's & Dementia provides important details on a pivotal United States Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER).
The U.S. POINTER study will be conducted to confirm and expand the results of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) in Americans, the latter of which showed that exercise, good food, and social activity helped older people at risk for memory loss. The POINTER study also aims to determine whether changes in how we live can preserve memory and thinking skills as we age.
Study design and methods: U.S. study to protect brain health through lifestyle intervention to reduce risk (U.S. POINTER). Image Credit: Chinnapong / Shutterstock.com
A recent Lancet Commission report describes the potential iofaddressing modifiable risk factors to prevent or delay approximately 40% of dementia cases. Multidomain interventions addressing multiple risk factors demonstrate significant promise over single-component interventions for reducing cognitive decline risk by allowing customization to individual needs, enhancing adherence, and addressing varied challenges.
The Finnish FINGER study illustrated the efficacy of multidomain interventions like physical activity and nutritional guidance in enhancing global cognition in at-risk older adults. Although promising, additional studies are imperative, as current multidomain lifestyle interventions have been associated with varied and inconclusive results.
Adapting and validating these interventions across diverse populations, while also considering cultural, racial, and socioeconomic variations, is crucial to ascertain their universal applicability and efficacy in preventing the development of Alzheimer's disease and related dementias.
About the POINTER study
The U.S. POINTER study is designed to explore the influence of two distinct lifestyle interventions on the cognitive function of 2,000 older adults over a two-year period. Although not significantly cognitively impaired, the study cohort is considered to be at risk for dementia. Modeled after the FINGER study, interventions in the POINTER study are based on American cultural and community settings while focusing on specific lifestyle behaviors linked to brain health.
The initiative, which is being anchored by Wake Forest University School of Medicine, is the most extensive lifestyle intervention study to date, as it involves academia, healthcare, and other organizations like the Alzheimer's Association. With guidance from numerous academic and community advisors, the study design was developed through comprehensive collaboration, a focus on diverse lifestyle practices, and extensive outreach.
A robust organizational structure comprising executive leadership and steering committees ensures quality, safety, and thorough data management across five diverse clinical sites. This facilitates a detailed exploration of intervention impacts on diverse populations.
How will the study be conducted?
The U.S. POINTER study represents a comprehensive research initiative seeking to assess the effects of lifestyle interventions on maintaining cognitive function in older adults at risk for Alzheimer's Disease-Related Dementias (ADRD).
A total of 2,000 participants aged 60-79 will be randomly assigned to one of two diverse intervention groups. Each group emphasizes different aspects of lifestyle modifications, including exercise, diet, cognitive stimulation, and cardiovascular risk reduction.
This study design allows researchers to strategically explore the multifaceted impacts on cognitive preservation in the elderly. Furthermore, the current study places great emphasis on the principles of diversity, equity, and inclusion, with stringent protocols for participant, investigator, and staff representation. Diverse and culturally informed strategies are also adopted for recruitment and maintain an inclusive environment.
All interventions vary in structure, with the Self-Guided (SG) approach focusing on individualized programs and sporadic support meetings. Comparatively, the Structured (STR) approach provides intensive and structured programs with a multifaceted approach to lifestyle modification, regular health monitoring, and facilitator support.
U.S. POINTER seeks to deliver holistic care and lifestyle modification through regular classes, nutritional counseling, dietary adherence support, and health check-ups. This is supported by rigorous recruitment strategies, meticulous documentation of progress, and extensive assessments.
Cognitive outcomes are determined through comprehensive assessments, including the POINTER-modified Neuropsychological Test Battery (PmNTB), which amalgamates various composites to provide robust and reliable data. Thorough masking procedures by staff and participants are overseen by an external board to ensure participant safety and the integrity of study results.
The study design has undergone essential adaptations to ensure continuity during the global coronavirus disease 2019 (COVID-19) pandemic by incorporating virtual components when necessary. Strict adherence to intervention fidelity is also ensured through extensive training, certification, and re-certification of interventionists and navigators.
The study's data handling is methodical and secure, as it is overseen by the Data Coordinating Center (DCC) to maintain confidentiality and accuracy. The intricacies of this study extend to its power and sample size, as they are calculated based on detailed projections from relevant trials aimed to guarantee the reliability of outcomes.
In its analytical approach, U.S. POINTER employs an intent-to-treat approach and intricate statistical models to study the global cognition composite from baseline through the 24-month assessment, including monitoring adverse events and assessing any potential differences in intervention response due to various risk factors. Alongside, National Institutes of Health (NIH)-funded ancillary studies are enhancing scientific insight by exploring various facets of cognitive response to treatment, employing diverse technologies and methodologies, and offering comprehensive insights into treatment effects on pathophysiology related to Alzheimer's and cerebrovascular disease.
The study is due for completion in July 2025.
- Baker, L. D., Snyder, H. M., Espeland, M. A., et al. (2023). Study design and methods: U.S. study to protect brain health through lifestyle intervention to reduce risk (U.S. POINTER). Alzheimer's & Dementia. doi:10.1002/alz.13365