Clinical trial Recruiting at 1 site Interventional Ages 60 to 80

Lifestyle for Brain Health — Time-Restricted Eating and Mindfulness

Official title: Lifestyle for the BRAin Health - Time Restricted Eating and Mindfulness

Run by St. Anne's University Hospital Brno, Czech Republic · NCT07042087 · Data updated 2026-11-12

This 9-month program tests whether combining yoga-based mindfulness with time-restricted eating improves cognition, physical fitness, metabolism, and plasma tau levels in adults 60–80 with subjective or mild cognitive impairment and positive pTau217.

More Alzheimer Disease trials

Quick facts

Study typeInterventional
Ages60 Years to 80 Years
SexAll
Enrollment48 (estimated)
SponsorSt. Anne's University Hospital Brno, Czech Republic
Academic / other
Locations1 site (Brno)
StatusRecruiting
StartedNovember 1, 2024
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedJune 27, 2025
Trial IDNCT07042087 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 60–80 with subjective cognitive impairment or mild cognitive impairment, MMSE 24–30, positive plasma pTau217, able to commit to a 9-month program and stable on any cholinesterase inhibitor therapy if applicable.

Probably not a fit

People with recent stroke or myocardial infarction, unstable or decompensated major medical conditions, active cancer within 5 years, significant neurological or sensory/motor impairments, long-term uncontrolled psychiatric illness, substance abuse, poor anticipated compliance, or unstable dementia medications are unlikely to benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized two-arm, 9-month intervention comparing mindfulness yoga plus time-restricted eating and nutritional counseling against cognitive training plus stretching in older adults at increased risk for Alzheimer disease. Primary and secondary outcomes include cognitive performance, plasma pTau217 as a marker of neurodegeneration, measures of physical fitness, and metabolic health. The protocol is harmonized with a parallel LIBRA-NET study at Slovak sites so that data from the cognitive-training/stretching arm and some clinical parameters are pooled for joint analysis. The combined approach tests whether lifestyle changes can modify both clinical and biomarker indicators of early neurodegeneration.

Why it matters

Potential benefit: If successful, this could offer a non-drug lifestyle approach to slow cognitive decline and reduce blood markers of neurodegeneration in at-risk older adults.

How similar studies have gone: Individual components—mindfulness/yoga, cognitive training, and time-restricted eating—have shown some cognitive or metabolic benefits in prior studies, but combining these interventions and measuring effects on plasma pTau217 is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Fnusa/ Icrc
    Brno, Czechia
    Recruiting

Study contacts

  • Principal investigator: Kateřina Sheardova, MD. PhD. — The International Clinical Research Center of St. Anne's University Hospital in Brno (FNUSA-ICRC)

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.