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Cognitive ImpairmentNCT07146412

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

A study testing Multimodal Lifestyle Intervention in people with Cognitive Impairment and Alzheimer Blood Biomarkers, run by HudsonAlpha Institute for Biotechnology at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 75 yearsHealthy volunteers can take part
What is being tested?
Multimodal Lifestyle Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
2 May 2025to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Smith Family Clinic for Genomic Medicine

    Huntsville, Alabama, 35806

Other trials in United States

About this 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.

Being tested
Multimodal Lifestyle Intervention
Keywords
alzheimer, cognitive impairment, APOE, PRS, pTau217
Medical subject headings
Cognitive Dysfunction, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multimodal Lifestyle InterventionBehavioural

    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.

Study groups in NCT07146412
Study groupRoleWhat they receive
Not high risk for conversion to cognitive impairmentNo interventionThis 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.
High risk for conversion to cognitive impairmentExperimentalThis 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).
Receives: Behavioral: Multimodal Lifestyle Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    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).

    Measured: 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.

  2. REVEAL Impact of Genetics Testing in Alzheimer's Disease Distress Subscale

    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.

    Measured: Week 1 and Week 26 (1 week after return of results visit, and also at final site visit).

Secondary outcomes (2)

  1. pTau217 level

    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.

    Measured: 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.

  2. MoCA score

    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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2025
  2. Study start2 May 2025
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07146412
Sponsor's protocol ID
0124
Status last verified
Sep 2026
First submitted
15 Aug 2025
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All available IPD will be shared with qualified researchers under controlled access.

Publications

  • Chung WW, Chen CA, Cupples LA, Roberts JS, Hiraki SC, Nair AK, Green RC, Stern RA. A new scale measuring psychologic impact of genetic susceptibility testing for Alzheimer disease. Alzheimer Dis Assoc Disord. 2009 Jan-Mar;23(1):50-6. doi: 10.1097/wad.0b013e318188429e.

    PubMed 19266699

  • Kim S, Sargent-Cox K, Cherbuin N, Anstey KJ. Development of the motivation to change lifestyle and health behaviours for dementia risk reduction scale. Dement Geriatr Cogn Dis Extra. 2014 Jun 5;4(2):172-83. doi: 10.1159/000362228. eCollection 2014 May.

    PubMed 25028583

  • Kasparian NA, Wakefield CE, Meiser B. Assessment of psychosocial outcomes in genetic counseling research: an overview of available measurement scales. J Genet Couns. 2007 Dec;16(6):693-712. doi: 10.1007/s10897-007-9111-6. Epub 2007 Aug 13.

    PubMed 17694397

  • Baker LD, Espeland MA, Whitmer RA, Snyder HM, Leng X, Lovato L, Papp KV, Yu M, Kivipelto M, Alexander AS, Antkowiak S, Cleveland M, Day C, Elbein R, Tomaszewski Farias S, Felton D, Garcia KR, Gitelman DR, Graef S, Howard M, Katula J, Lambert K, Matongo O, McDonald AM, Pavlik V, Raman R, Salloway S, Tangney C, Ventrelle J, Wilmoth S, Willliams BJ, Wing R, Woolard N, Carrillo MC. Structured vs Self-Guided Multidomain Lifestyle Interventions for Global Cognitive Function: The US POINTER Randomized Clinical Trial. JAMA. 2025 Aug 26;334(8):681-691. doi: 10.1001/jama.2025.12923.

    PubMed 40720610

  • Ornish D, Madison C, Kivipelto M, Kemp C, McCulloch CE, Galasko D, Artz J, Rentz D, Lin J, Norman K, Ornish A, Tranter S, DeLamarter N, Wingers N, Richling C, Kaddurah-Daouk R, Knight R, McDonald D, Patel L, Verdin E, E Tanzi R, Arnold SE. Effects of intensive lifestyle changes on the progression of mild cognitive impairment or early dementia due to Alzheimer's disease: a randomized, controlled clinical trial. Alzheimers Res Ther. 2024 Jun 7;16(1):122. doi: 10.1186/s13195-024-01482-z.

    PubMed 38849944

  • Roach JC, Rapozo MK, Hara J, Glusman G, Lovejoy J, Shankle WR, Hood L; COCOA Consortium:. A Remotely Coached Multimodal Lifestyle Intervention for Alzheimer's Disease Ameliorates Functional and Cognitive Outcomes. J Alzheimers Dis. 2023;96(2):591-607. doi: 10.3233/JAD-230403.

    PubMed 37840487

  • Roach JC, Hara J, Fridman D, Lovejoy JC, Jade K, Heim L, Romansik R, Swietlikowski A, Phillips S, Rapozo MK, Shay MA, Fischer D, Funk C, Dill L, Brant-Zawadzki M, Hood L, Shankle WR. The Coaching for Cognition in Alzheimer's (COCOA) trial: Study design. Alzheimers Dement (N Y). 2022 Jul 26;8(1):e12318. doi: 10.1002/trc2.12318. eCollection 2022.

    PubMed 35910672

  • Kivipelto M, Solomon A, Ahtiluoto S, Ngandu T, Lehtisalo J, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Nissinen A, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H. The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER): study design and progress. Alzheimers Dement. 2013 Nov;9(6):657-65. doi: 10.1016/j.jalz.2012.09.012. Epub 2013 Jan 17.

    PubMed 23332672

  • Dhana K, Evans DA, Rajan KB, Bennett DA, Morris MC. Healthy lifestyle and the risk of Alzheimer dementia: Findings from 2 longitudinal studies. Neurology. 2020 Jul 28;95(4):e374-e383. doi: 10.1212/WNL.0000000000009816. Epub 2020 Jun 17.

    PubMed 32554763

Questions about this trial

What is this clinical trial studying?

A study testing Multimodal Lifestyle Intervention in people with Cognitive Impairment and Alzheimer Blood Biomarkers, run by HudsonAlpha Institute for Biotechnology at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07146412, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.

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