About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Sequential
Treatments tested in this trial
Multimodal Lifestyle Intervention
BehavioralThe intervention supports adoption and maintenance of healthy behaviors including healthy nutrition The Mediterranean-DASH (Dietary Approaches to Stop Hypertension) Intervention for Neurodegenerative Delay, or MIND Diet), physical activity (150 min/week of moderate activity), stress management, weight management, and adherence to doctor-prescribed medical regimens. In addition, participants will be encouraged to participate regularly in social and learning activities, and to engage in cognitive training via Posit's BrainHQ web-based training tools (brainhq.com). Participants will be supported by telephone-based health coaching. Coaches will be currently licensed allied health providers such as Registered Dietitians. Using the combination of an individual's biological data (including genomics, blood, stool, saliva, etc.), activity data, behavioral data, and other incoming streams of health information, the coach will tailor the lifestyle intervention for each participant.
Treatment groups
Trial outcomes
Primary outcomes
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.
All participants will be offered a survey about perception of and attitudes toward dementia risk using the scaling strategy described by Kasparian and colleagues and dementia questions from Kim and colleagues (see references).
REVEAL Impact of Genetics Testing in Alzheimer's Disease Distress Subscale
Participants identified as high risk (multimodal lifestyle intervention arm) will be asked to complete the REVEAL (Risk Evaluation and Education for Alzheimer's Disease) Impact of Genetics Testing in Alzheimer's Disease (IGT-AD) Distress Subscale. The scale is 12 items on a Likert scale, with higher scores indicating more distress.
Secondary outcomes
pTau217 level
Level of pTau217 (picograms/milliliter, pg/mL). Limit of quantification 0.06 pg/mL, assay detection limit 0.03 pg/mL, threshold \>0.18 pg/mL indicated as a surrogate marker for beta amyloid pathology, no upper bound specified by testing lab (labcorp). Higher scores indicate a worse outcome.
MoCA score
Montreal Cognitive Assessment. Range 0-30. Lower scores correlate with more cognitive impairment. Study threshold for possible mild cognitive impairment (MCI) set at \<25, but in this secondary outcome measure MoCA score will be evaluated as a continuous value. Lower scores indicate a worse outcome.
Sponsors and contacts
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