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

StatusActive, Not Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 8 months later Apr 30, 2026 → Dec 30, 2026
See other at-risk trials from HudsonAlpha Institute for Biotechnology

Record History

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  1. Notable Primary and study completion pushed from Apr 30, 2026 to Dec 30, 2026 Show 6 more changesShow less
    • Primary endpoints: details revised at 1 of 2 entries
    • Enrollment closed, study ongoing
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Site details revised
    • Publications: details revised at 9 of 9 entries
  2. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT07146412
Lead Sponsor HudsonAlpha Institute for Biotechnology
Conditions
(from sponsor)
Cognitive Impairment, Alzheimer Blood Biomarkers, Alzheimer Disease (AD), Mild Cognitive Impairment (MCI)
Related terms Alzheimer Disease, Cognitive Dysfunction
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov