U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alzheimer Disease
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 2000
- Locations
- 6
- Primary Endpoint
- Global cognitive function composite score
- Status
- Completed
- Last Updated
- 6 months ago
Overview
Brief Summary
The purpose of this research study is to see if lifestyle changes can protect memory and thinking (cognition) as we age. A recent study in Finland found that a combination of physical and cognitive exercise, diet, and social activity protected cognitive function in healthy older adults who were at increased risk of significant memory loss. So far no medications can rival this positive outcome. The point of POINTER is to test if lifestyle change can also protect against memory loss in Americans.
Detailed 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 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Sedentary (not a regular exerciser, determined using the POINTER--modified Telephone Assessment of Physical Activity \[TAPA\]
- •Low MIND Diet score (determined using the MIND Diet Screener)
- •No cognitive impairment as per Telephone Interview for Cognitive Status (mTICS) score \>32 (includes adjustments for demographics such as age, education and race), the Clinical Dementia Rating Scale (CDR \<0.5), and the CDR-Sum of Boxes (CDR-SB \<1)
- •Risk Score for cognitive decline \>2, using the following scoring algorithm:1 point: Suboptimum cardiovascular health (treated or untreated): systolic Blood Pressure \>125 mmHg \~OR\~ low-density lipoprotein (LDL) cholesterol \>115 mg/dL\~OR\~ glycated hemoglobin (HbA1c) \>6.0%1 point: First degree family history (mother, father, sister, brother) of memory impairment- 1 point: Race and ethnicity: African American/Black, Native American, Middle Eastern/North African, or Hispanic/Latinx
- •1 point: Older age: 70-79 years 1 point: Sex: male
- •Lives in a region where the POINTER interventions will be delivered
- •Does not plan to travel outside of the home geographic area for an extended period of time during study participation
- •Capacity to complete physical exercise
- •Willing to complete all study-related activities for at least 24 months
- •Willing to be randomized to either lifestyle intervention group
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Global cognitive function composite score
Time Frame: up to 2 years
Global cognitive function will be obtained from a composite score derived from subtest scores on the POINTER modified Neuropsychological Test Battery (PmNTB) that includes: Free and Cued Selective Reminding Test, Story Recall, Visual Paired Associates, Number Span, Word Fluency, Trail-Making Test, and Digit Symbol Substitution Test. Scores from each individual test will be converted to z-scores that typically range from -3 to 3, with higher scores reflecting better performance, and averaged to form a composite. The primary outcome is the slope of these composite scores over repeated assessments (standard deviation units per year), with less negative (or positive) slopes reflecting better performance.
Secondary Outcomes
- Episodic memory composite score(up to 2 years)
- Executive function composite score(up to 2 years)
- Processing speed composite score(up to 2 years)
- Clinical dementia rating-sum of boxes(up to 2 years)
- Instrumental activities of daily living (IADL) score(up to 2 years)
- Everyday cognition (ECog) score(up to 2 years)
- Digital clock drawing test (DCTClock) time(up to 2 years)
- Lifestyle composite score(up to 2 years)
- Deficit accumulation frailty index score(up to 2 years)