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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 75
Healthy Volunteers: t
View:

• 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

Locations
United States
Alabama
Smith Family Clinic for Genomic Medicine
RECRUITING
Huntsville
Contact Information
Primary
Jesse N Cochran, PhD
ncochran@hudsonalpha.org
256-327-5262
Time Frame
Start Date: 2025-05-02
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 200
Treatments
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).
Sponsors
Leads: HudsonAlpha Institute for Biotechnology

This content was sourced from clinicaltrials.gov