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

Обзор

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.

Вмешательства

• Поведенческое Multimodal Lifestyle Intervention
  The 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

Первичные конечные точки

• 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. [Срок оценки: 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 [Срок оценки: Week 1 and Week 26 (1 week after return of results visit, and also at final site visit).]

Вторичные конечные точки (2)

• pTau217 level [Срок оценки: Measured at screening (week -26 to -4), and, for high risk participants, at enrollment for intervention (week 0) as well as at 26 weeks into completing a multimodal lifestyle intervention.]
• MoCA score [Срок оценки: Measured at screening (week -26 to -4), and, for high risk participants, at enrollment for intervention (week 0) as well as at 26 weeks into completing a multimodal lifestyle intervention.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Smith Family Clinic for Genomic Medicine — Huntsville

Публикации

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Идентификаторы

NCT: NCT07146412 · 0124

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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