Impact of a Multimodal Lifestyle Intervention on Dementia Risk Factors and Attitude Related to Dementia Risk: A Logistical Pilot Study
Recruiting · NCT07146412 · Interventional (participants receive a specific treatment) · Lead sponsor: HudsonAlpha Institute for Biotechnology
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is 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.
Who can take part
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
Where it is running
1 location listed across 1 US state.
- Smith Family Clinic for Genomic Medicine - Huntsville, Alabama, United States