Fortifying Healthy Behaviors, Optimizing Medical Therapies and Enhancing Cognitive Function in Older Adults-pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Number of participants who completed the outcome measure assessments and intervention
研究概览
简要总结
The purpose of this research study is to explore ways to improve motor, cognitive and immune functions for aging adults using multiple techniques like lifestyle changes and risk factor management, as well as medications and supplements believed to have a positive effect on health.
详细描述
The goal in this pilot open-label study is to conduct a feasibility test of a multi-component, personalized intervention designed to improve the aging human healthspan. The trial will recruit at least 20 adults aged 50-70, both male and female. The total time of study participation is up to 5 months.
The intervention will last for approximately 3 months, with testing of motor, cognitive, and immune outcomes before and after the intervention.
The intervention consist of three components:
- Fortify Healthy Behaviors: behavioral lifestyle management that combines an exercise program, healthy eating behaviors and optimizing sleep quality;
- Optimize Medical Therapies: reviewing the participants cardiovascular risk factors, smoking cessation when indicated, treatment with the senolytic medication dasatinib combined with the antioxidant quercetin , and dietary supplements relevant for brain, bone and immune system functioning; and
- Enhance Cognitive Function: vortioxetine (an antidepressant shown to have pro-cognitive properties), in combination with digital cognitive training to improve fluid cognition and memory, and deprescribing of drugs with CNS toxicity (i.e. those that cause cognitive difficulties).
The outcome assessments will be measured both pre- and post-intervention and up to three times at each time point. These assessments will look at biomarkers related to aging. Assessments will include strength and endurance tests, validated neuropsychological tests, and a blood drawn to look at immune function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be residents of Illinois or Missouri and able to come to St. Louis offices in person.
- •Inclusion Criteria:
- •Ages 50-70
- •Able to come to the research center for testing and intervention visits.
- •Sedentary (no moderate exercise and no more than 15-minutes per day of light exercise (confirmed via interview with participants)).
- •BMI≥27 or Body Roundness index ≥6
- •Able to provide informed consent.
排除标准
- •Dementia or other clinical neurodegenerative illness (e.g., Parkinson's disease, cerebrovascular disease unless minor eg one lacunar infarct with minimal/no impairment) per self-report or medical records.
- •Medical conditions that suggest shortened lifespan (such as metastatic cancer), severe/uncontrolled psychiatric disorders or conditions that would prohibit safe participation.
- •Unable to perform study assessments.
- •Alcohol or substance abuse within 6 months per self-report or medical records.
- •Concurrent cognitive training, such as brain-training software, or other interventions expected to affect neuroplasticity.
- •Any drug that interacts pharmacokinetically, or is contraindicated with study interventions (examples would include high-dose SSRI that should not be combined with vortioxetine)
- •PI has discretion to exclude potential participants eg if their health status appears either too good or too poor to be amenable to intervention
研究组 & 干预措施
Behavioral lifestyle management plus dasatinib, quercetin and vortioxetine
Open label multicomponent, personalized intervention incorporating behavioral and medicinal therapies
干预措施: Dasatinib (Drug)
Behavioral lifestyle management plus dasatinib, quercetin and vortioxetine
Open label multicomponent, personalized intervention incorporating behavioral and medicinal therapies
干预措施: Quercetin (dietary supplement) (Dietary Supplement)
Behavioral lifestyle management plus dasatinib, quercetin and vortioxetine
Open label multicomponent, personalized intervention incorporating behavioral and medicinal therapies
干预措施: Vortioxetine (Drug)
Behavioral lifestyle management plus dasatinib, quercetin and vortioxetine
Open label multicomponent, personalized intervention incorporating behavioral and medicinal therapies
干预措施: Risk managment (Behavioral)
结局指标
主要结局
Number of participants who completed the outcome measure assessments and intervention
时间窗: 5 months
Reviewing feasibility outcomes including recruitment, retention, participant adherence, interventionist fidelity to behavioral treament protocols and collection of outcome measures.
次要结局
未报告次要终点