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

HudsonAlpha Institute for Biotechnology

Status: Enrolling

Conditions: Mild Cognitive Impairment (MCI); Cognitive Impairment; Alzheimer Blood Biomarkers; Alzheimer Disease (AD)

Treatments: Behavioral: Multimodal Lifestyle Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07146412

0124

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 65 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Not high risk for conversion to cognitive impairment

No Intervention group

Description:

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.

High risk for conversion to cognitive impairment

Experimental group

Description:

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).

Treatment:

Behavioral: Multimodal Lifestyle Intervention