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NCT Number: NCT07146412

Impact of a Multimodal Lifestyle Intervention on Dementia Risk Factors and Attitude Related to Dementia Risk: A Logistical Pilot Study

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.

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Key information

Conditions

Cognitive Impairment Alzheimer Blood Biomarkers Alzheimer Disease Alzheimer Disease (AD) Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Mild Cognitive Impairment (MCI) Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

65 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Smith Family Clinic for Genomic Medicine

Huntsville, Alabama, 35806, United States

Location status: Recruiting

Location contact

Meagan E Cochran, MS, CGC

CONTACT

[email protected]

256-327-9777

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multimodal lifestyle intervention

Behavioral

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 outcomes

  1. 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.

    All participants will be offered a survey about perception of and attitudes toward dementia risk using the scaling strategy described by Kasparian and colleagues and dementia questions from Kim and colleagues (see references).

  2. 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).

    Participants identified as high risk (multimodal lifestyle intervention arm) will be asked to complete the REVEAL (Risk Evaluation and Education for Alzheimer's Disease) Impact of Genetics Testing in Alzheimer's Disease (IGT-AD) Distress Subscale. The scale is 12 items on a Likert scale, with higher scores indicating more distress.

Secondary outcomes

  1. pTau217 level

    Time frame: Measured at screening (week -26 to -4), and, for high risk participants, at enrollment for intervention (week 0) as well as at 26 weeks into completing a multimodal lifestyle intervention.

    Level of pTau217 (picograms/milliliter, pg/mL). Limit of quantification 0.06 pg/mL, assay detection limit 0.03 pg/mL, threshold >0.18 pg/mL indicated as a surrogate marker for beta amyloid pathology, no upper bound specified by testing lab (labcorp). Higher scores indicate a worse outcome.

  2. MoCA score

    Time frame: Measured at screening (week -26 to -4), and, for high risk participants, at enrollment for intervention (week 0) as well as at 26 weeks into completing a multimodal lifestyle intervention.

    Montreal Cognitive Assessment. Range 0-30. Lower scores correlate with more cognitive impairment. Study threshold for possible mild cognitive impairment (MCI) set at <25, but in this secondary outcome measure MoCA score will be evaluated as a continuous value. Lower scores indicate a worse outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Jesse N Cochran, PhD

CONTACT

[email protected]

256-327-5262

Sponsors and collaborators

Lead sponsor

HudsonAlpha Institute for Biotechnology

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 28, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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