U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Alzheimer Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Care Provider, Investigator, Outcomes Assessor)Masking Description: The U.S. POINTER Coordinating Center (CC) is divided into two distinct entities: the Administrative and Clinical Operations CC and the Data CC. Investigators and staff within the Administrative and Clinical Operations CC will be masked to outcomes data. Investigators and staff within the Data CC will be unmasked to intervention assignment and outcomes. In the clinic, examiners, data entry staff, and the study clinician will be masked to intervention assignment.Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 60 years and 79 years
- Gender
- Both males and females
Description
Lifestyle interventions focused on combining healthy diet, physical activity, and social and intellectual challenges may represent a promising therapeutic strategy to protect brain health. The recent results of the population-based 2-year clinical trial, Finnish Geriatric Intervention Study to Preve...
Lifestyle interventions focused on combining healthy diet, physical activity, and social and intellectual challenges may represent a promising therapeutic strategy to protect brain health. The recent results of the population-based 2-year clinical trial, Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER), indicated that a multidomain intervention of physical activity, nutritional guidance, cognitive training, social activities, and management of heart health risk factors protected cognitive function in healthy older adults at increased risk of cognitive decline. As yet, there are no pharmacological treatment options that can rival this effect. Thus, there is an urgent need to expand this work to test the generalizability, adaptability and sustainability of its findings in diverse and global populations. This pivotal U.S. Study to Protect Brain Health through Lifestyle Intervention to Reduce Risk (U.S. POINTER) will test whether a similar 2-year intensive lifestyle intervention, adapted to American culture and delivered within the community, can protect cognitive function in older adults in the U.S. who are at increased risk for cognitive decline and dementia. If successful, the results of this study will have large-scale implications for public policy regarding standard of clinical care and prescriptive practices for a fast-growing and vulnerable population of older adults.
Tracking Information
- NCT #
- NCT03688126
- Collaborators
- Alzheimer's Association
- Investigators
- Principal Investigator: Laura D Baker, PhD Wake Forest University Health Sciences Principal Investigator: Mark A Espeland, PhD Wake Forest University Health Sciences Principal Investigator: Rachel A Whitmer, PhD University of California, Davis Principal Investigator: Miia Kivipelto, MD, PhD Karolinska Institutet
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