U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk

Status: Active_not_recruiting
Location: See all (6) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 79
Healthy Volunteers: t
View:

⁃ 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

Locations
United States
California
Northern California
Sacramento
Illinois
Chicagoland--Rush
Chicago
Chicagoland--Advocate Aurora Health
Downers Grove
North Carolina
North Carolina
Winston-salem
Rhode Island
New England--Rhode Island
Providence
Texas
Houston
Houston
Time Frame
Start Date: 2019-01-08
Completion Date: 2025-07
Participants
Target number of participants: 2000
Treatments
Experimental: Self-Guided Lifestyle Intervention
Lifestyle modification program that is developed by the participant to meet his/her specific needs.
Experimental: Structured Lifestyle Intervention
Lifestyle modification program that involves participants completing structured activities that target diet, physical exercise, and intellectual and social stimulation.
Related Therapeutic Areas
Sponsors
Collaborators: Alzheimer's Association
Leads: Wake Forest University Health Sciences

This content was sourced from clinicaltrials.gov

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