Recruiting

Lifestyle Intervention

Sponsor:

HudsonAlpha Institute for Biotechnology

Code:

NCT07146412

Conditions

Cognitive Impairment

Alzheimer Blood Biomarkers

Alzheimer Disease (AD)

Mild Cognitive Impairment (MCI)

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

Interventions

Multimodal Lifestyle Intervention

Study Details

Brief summary:

Many individuals develop dementia, and dementia has multiple causes, yet we currently have limited treatment options. A critical observation of the effectiveness of the available dementia treatments is that they tend to be more effective when started early. Previous studies have shown that multimodal lifestyle interventions can significantly delay the onset of Alzheimer's dementia in individuals with high risk for Alzheimer's or with Mild Cognitive Impairment (MCI). These interventions may be less effective when initiated after dementia has already been diagnosed or is more advanced.

This study has two primary goals. The first goal is to assess attitudes around dementia risk for participants throughout the study as they learn of their personalized risk and possible lifestyle factors that may modify that risk. The second goal is to serve as a logistical pilot for the implementation of data collection and processing and multimodal lifestyle intervention to reduce the risk factors of dementia in individuals without current cognitive impairment but who are at high risk of progression to dementia. Secondary goals of this study include better defining what factors contribute the most risk to dementia and identifying sub-types of dementia defined by different genetic and molecular risk factors.

Conditions

Cognitive Impairment

Alzheimer Blood Biomarkers

Alzheimer Disease (AD)

Mild Cognitive Impairment (MCI)

Study ID

NCT07146412

Start date

May 2, 2025

Status verified date

Aug, 2025

Completion date

Apr 30, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adults 65-75 years of age at enrollment with at least one self-reported 1st-degree relative who had or has any kind of dementia
  • Montreal Cognitive Assessment (MoCA) score > 24 at initial enrollment
  • Able and willing to comprehend and sign the informed consent document
  • Able and willing to perform required physical performance tests
  • Able and willing to provide the study's minimum samples
  • Able and willing to conduct the study's minimum procedures
  • Able and willing to complete surveys, cognitive assessments, and questionnaires in English only
  • Has or has ready access to a PC, tablet, or smartphone with an internet connection required for procedures that they consent to

Exclusion Criteria:

  • A diagnosis of cognitive impairment of any kind, including Alzheimer's disease, mild cognitive impairment, or any other diagnosis of dementia
  • If a subject is found to have cognitive impairment at initial enrollment (Montreal Cognitive Assessment (MoCA) score<25), they will be excluded from the study
  • Self-reported pregnancy
  • Children under 19 years of age
  • Individuals not fluent in written and spoken English
  • Self-reported chronic or end-stage disease that would interfere with their participation in the study
  • Hospitalization for any reason in the past 3 months
  • Severe hearing and visual impairment that would interfere with the ability to complete study measures
  • Any other vulnerable subject at the time of enrollment as specified above

Study Design

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Not high risk for conversion to cognitive impairment

This group will be defined by individuals who are not high risk by our study-defined rubric taking family history, Apolipoprotein E (APOE) genotype, Alzheimer's disease (AD) polygenic risk score (PRS), modified Cardiovascular Risk Factors, Aging and Incidence of Dementia (mCAIDE) score, lifestyle score described by Dhana and colleauges (see references section), Montreal Cognitive Assessment (MoCA), self-reported race/ethnicity, and pTau217 level into account.

experimental: High risk for conversion to cognitive impairment

This group will be defined by individuals who are high risk by our study-defined rubric taking family history, APOE genotype, AD PRS, mCAIDE score, lifestyle score described by Dhana and colleauges (see references section), MoCA, self-reported race/ethnicity, and pTau217 level into account. Individuals in this group will be offered a multimodal lifestyle intervention targeting the prevention of cognitive decline based on previous studies of lifestyle interventions for the prevention or delay of dementia as described in previous studies (see references section).

Interventions

Multimodal Lifestyle Intervention

The intervention supports adoption and maintenance of healthy behaviors including healthy nutrition The Mediterranean-DASH (Dietary Approaches to Stop Hypertension) Intervention for Neurodegenerative Delay, or MIND Diet), physical activity (150 min/week of moderate activity), stress management, weight management, and adherence to doctor-prescribed medical regimens. In addition, participants will be encouraged to participate regularly in social and learning activities, and to engage in cognitive training via Posit's BrainHQ web-based training tools (brainhq.com). Participants will be supported by telephone-based health coaching. Coaches will be currently licensed allied health providers such as Registered Dietitians. Using the combination of an individual's biological data (including genomics, blood, stool, saliva, etc.), activity data, behavioral data, and other incoming streams of health information, the coach will tailor the lifestyle intervention for each participant.

Primary outcome measure

  • Attitudes around dementia risk for participants throughout the study as they learn of their personalized risk and possible lifestyle factors that may modify that risk. [ Time Frame: At enrollment (week -26 to week -4), at return of results visit indicating level of dementia risk (week 0), and (for participant that qualify for the multimodal lifestyle intervention arm) at week 26. ]
  • REVEAL Impact of Genetics Testing in Alzheimer's Disease Distress Subscale [ Time Frame: Week 1 and Week 26 (1 week after return of results visit, and also at final site visit). ]

Central Contacts and Locations

Central contacts

Jesse N Cochran, PhD

256-327-5262ncochran@hudsonalpha.org

Locations

Smith Family Clinic for Genomic Medicine

Recruiting

Huntsville, Alabama, United States, 35806

Contacts

Meagan E Cochran, MS, CGC

256-327-9777mcochran@smithfamilyclinic.org

More Information

Sponsor

HudsonAlpha Institute for Biotechnology

Last update posted

Aug 28, 2025

Last verified

Aug, 2025

Keywords

  • alzheimer
  • cognitive impairment
  • APOE
  • PRS
  • pTau217

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by HudsonAlpha Institute for Biotechnology on 2025-08-28.