Lifestyle for the BRAin Health - Time Restricted Eating and Mindfulness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Composite Score of Cognitive Function
研究概览
简要总结
The study aims to evaluate the effects of a 9-month intervention combining yoga-based mindfulness techniques, cognitive training, and nutritional counseling on cognitive function, plasma markers of neurodegeneration (tau protein), physical fitness, and metabolism in older adults at increased risk of developing Alzheimer's disease.
详细描述
This randomized two-arm clinical trial aims to evaluate the effects of a 9-month intervention combining yoga-based mindfulness techniques and time-restricted eating (Arm 1) versus cognitive training and stretching (Arm 2) in older adults at increased risk of developing Alzheimer's disease. The study will assess outcomes including cognitive function, plasma biomarkers of neurodegeneration (tau protein), physical fitness, and metabolic health.
The trial is harmonized with the concurrently running LIBRA-NET study (NCT06986096) conducted at Slovak sites (Bratislava and Banská Bystrica). Data from the cognitive training arm and additional clinical parameters will be pooled across both studies for joint statistical analyses. The studies share primary and several secondary outcomes, a shared intervention timeline, assessment protocols, and the cognitive training/stretching arm. The harmonization across all four study sites aims to increase statistical power and enable more generalizable conclusions for a larger population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60-80 years
- •Diagnosis of Subjective Cognitive Impairment (SCI) or Mild Cognitive Impairment (MCI)
- •mini-mental-scale (MMSE) score between 24-30
- •Positive plasma pTau217 biomarker
- •Stable dose of iAChE therapy (if applicable)
- •Ability to participate in a 9-month intervention
排除标准
- •Stroke or myocardial infarction within the past year
- •Decompensated internal conditions (e.g., severe heart failure, kidney failure, unstable diabetes, GLP1 agonist therapy)
- •Long-term psychiatric treatment (except well-managed depression)
- •Neurological conditions affecting mobility or cognition (e.g., Parkinson's disease, severe tremor, epilepsy)
- •Severe sensory or motor impairment preventing protocol participation
- •Active cancer treated within the past 5 years
- •Poor anticipated compliance (e.g., transport issues, time constraints, non-cooperation)
- •Concurrent participation in another clinical study
- •Unstable iAChE medication regimen
- •Substance or alcohol dependence
结局指标
主要结局
Composite Score of Cognitive Function
时间窗: Baseline and 9 months
Change in composite neuropsychological score from baseline to post-intervention (9 months), including domain-specific scores for memory, executive function/attention, and psychomotor speed.
Plasma Biomarkers of Neurodegeneration
时间窗: Baseline and 9 months
Change in concentrations of plasma biomarkers: phosphorylated tau (pTau217, pTau181), GFAP, and neurofilament light chain (NfL).
次要结局
- Computerized Cognitive Test Scores - Cogstate(Baseline and 9 months)
- Geriatric depression scale(Baseline and 9 months)
- Adherence to Intervention(Throughout the 9-month intervention)
- Beck's anxiety inventory(Baseline and 9 months)
- Older People's Quality of Life Questionnaire scores(Time Frame: Baseline and 9 months)