Lifestyle for the BRAin Health - Time Restricted Eating and Mindfulness

Lifestyle for the BRAin Health - Time Restricted Eating and Mindfulness

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.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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