Multimodal Lifestyle Intervention for Dementia Risk Factors

This study is exploring how a Multimodal Lifestyle Intervention can impact dementia risk factors and people's attitudes about that risk. This intervention involves healthy eating (like the MIND Diet), regular physical activity (150 minutes per week of moderate activity), and stress management. The study aims to see how your attitudes about dementia risk change as you learn about your personal risk and how lifestyle choices might affect it. You may be able to join if you are 65-75 years old, have a close family member with dementia, and have a good score on a memory test (MoCA score > 24). The study plans to enroll 200 people.

Study design
This is an interventional pilot study with a planned enrollment of 200 participants. It is not specified if the study is randomized or blinded.
What's involved
You would participate in assessments at enrollment (between week -26 and week -4), at a visit where you receive your dementia risk results (week 0), and at week 26. You will also complete questionnaires about distress at week 1 and week 26.
Compensation
Not stated in the trial record.
Follow-up
Your attitudes around dementia risk will be measured throughout the study, with a final measurement at week 26. Distress will also be measured at week 26.

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NCT07146412

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

Recruiting
NAAges 65–75InterventionalPrevention
HudsonAlpha Institute for Biotechnology
~200 participants
Updated 2025-08-28 on ClinicalTrials.gov
What's tested:Multimodal Lifestyle Intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over 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.
+1 more outcome measured
Cognitive Impairment
Alzheimer Blood Biomarkers
Alzheimer Disease (AD)
Mild Cognitive Impairment (MCI)
1 sites across 1 states
Alabama1

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Eligibility criteria

Inclusion

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

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
  • 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.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).

  • REVEAL Impact of Genetics Testing in Alzheimer's Disease Distress SubscaleWeek 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.