A research article published within the journal Alzheimer’s & Dementia provides necessary 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 can be conducted to verify and expand the outcomes 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 in danger for memory loss. The POINTER study also goals to find out whether changes in how we live can preserve memory and considering skills as we age. 

Study design and methods: U.S. study to guard brain health through lifestyle intervention to scale back risk (U.S. POINTER). Image Credit: Chinnapong / Shutterstock.com

Background 

A recent Lancet Commission report describes the potential iofaddressing modifiable risk aspects to stop or delay roughly 40% of dementia cases. Multidomain interventions addressing multiple risk aspects display 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 dietary guidance in enhancing global cognition in at-risk older adults. Although promising, additional studies are imperative, as current multidomain lifestyle interventions have been related to varied and inconclusive results.

Adapting and validating these interventions across diverse populations, while also considering cultural, racial, and socioeconomic variations, is crucial to determine their universal applicability and efficacy in stopping the event of Alzheimer’s disease and related dementias.

In regards to the POINTER study

The U.S. POINTER study is designed to explore the influence of two distinct lifestyle interventions on the cognitive function of two,000 older adults over a two-year period. Although not significantly cognitively impaired, the study cohort is taken into account to be in danger for dementia. Modeled after the FINGER study, interventions within the POINTER study are based on American cultural and community settings while specializing in specific lifestyle behaviors linked to brain health.

The initiative, which is being anchored by Wake Forest University School of Medicine, is essentially the most extensive lifestyle intervention study so far, because it involves academia, healthcare, and other organizations just like the Alzheimer’s Association. With guidance from quite a few academic and community advisors, the study design was developed through comprehensive collaboration, a give attention to diverse lifestyle practices, and extensive outreach. 

A sturdy organizational structure comprising executive leadership and steering committees ensures quality, safety, and thorough data management across five diverse clinical sites. This facilitates an in depth exploration of intervention impacts on diverse populations.

How will the study be conducted?

The U.S. POINTER study represents a comprehensive research initiative in search of to evaluate the results of lifestyle interventions on maintaining cognitive function in older adults in danger for Alzheimer’s Disease-Related Dementias (ADRD).

A complete of two,000 participants aged 60-79 can be randomly assigned to certainly one of two diverse intervention groups. Each group emphasizes different facets of lifestyle modifications, including exercise, food regimen, cognitive stimulation, and cardiovascular risk reduction.

This study design allows researchers to strategically explore the multifaceted impacts on cognitive preservation within the elderly. Moreover, the present 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 specializing in 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, dietary counseling, dietary adherence support, and health check-ups. That 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 offer robust and reliable data. Thorough masking procedures by staff and participants are overseen by an external board to make sure participant safety and the integrity of study results.

The study design has undergone essential adaptations to make sure continuity in the course of the global coronavirus disease 2019 (COVID-19) pandemic by incorporating virtual components when crucial. Strict adherence to intervention fidelity can be ensured through extensive training, certification, and re-certification of interventionists and navigators.

The study’s data handling is methodical and secure, because it is overseen by the Data Coordinating Center (DCC) to keep up confidentiality and accuracy. The intricacies of this study extend to its power and sample size, as they’re calculated based on detailed projections from relevant trials aimed to ensure the reliability of outcomes.

In its analytical approach, U.S. POINTER employs an intent-to-treat approach and complex statistical models to review the worldwide cognition composite from baseline through the 24-month assessment, including monitoring antagonistic events and assessing any potential differences in intervention response as a consequence of various risk aspects. 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.