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Life sciences · Interventional Study
ClinicalTrials.gov · September 29, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07146412). This is a study registration, not published results. Lead sponsor: HudsonAlpha Institute for Biotechnology. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 200 participants (ESTIMATED). Conditions: Cognitive Impairment, Alzheimer Blood Biomarkers, Alzheimer Disease (AD), Mild Cognitive Impairment (MCI). Interventions: BEHAVIORAL: Multimodal Lifestyle Intervention. Primary outcome measures: 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.; REVEAL Impact of Genetics Testing in Alzheimer's Disease Distress Subscale , Week 1 and Week 26 (1 week after return of results visit, and also at final site visit).. Brief 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.