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Alzheimer DiseaseLIBRA REMINDNCT07042087

Lifestyle for the BRAin Health - Time Restricted Eating and Mindfulness

A study testing Mindfulness Yoga, Time-Restricted Eating with nutritional counseling promoting a flexitarian dietary pattern and Cognitive Training in people with Alzheimer Disease and Aging, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 60 to 80 years
Conditions the study is for
Alzheimer Disease, Aging, Lifestyle Factors
What is being tested?
Mindfulness Yoga, Time-Restricted Eating with nutritional counseling promoting a flexitarian dietary pattern and Cognitive Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteCzechia
Study dates
1 Nov 2024to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Czechia1 site, 1 recruiting

  • Fnusa/ Icrc

    Brno, 64400

    Kurečková Kurečková, Ing., +420 54 318 4086, monika.kureckova@fnusa.cz

    Kateřina Sheardova, MD. PhD.

    Recruiting

Other trials in Czechia

About this study

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.

Read the detailed description

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.

Being tested
Mindfulness Yoga, Time-Restricted Eating with nutritional counseling promoting a flexitarian dietary pattern, Cognitive Training, Stretching
Keywords
Alzheimer's Disease Prevention, Mindfulness-Based Intervention, Cognitive Training, Time-Restricted Eating, Dietary consultation
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction, Intermittent Fasting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness YogaBehavioural

    A structured 9-month program integrating physical yoga postures (asanas), breathing techniques, sound, and meditation. Sessions are conducted twice weekly (90 minutes each) and focus on enhancing physical health, stress regulation, and cognitive performance. Delivered by certified instructors.

  • Time-Restricted Eating with nutritional counseling promoting a flexitarian dietary patternBehavioural

    Participants follow a 16:8 time-restricted eating schedule (16 hours fasting / 8 hours eating window) for 9 months, with nutritional counseling promoting a flexitarian dietary pattern. The intervention is designed to support metabolic health and reduce risk factors for neurodegeneration.

  • Cognitive TrainingBehavioural

    A 9-month structured program of twice-weekly cognitive training sessions (90 minutes each), targeting memory, attention, executive function, and social cognition using both paper-based and computer-based tasks. Supervised by trained therapists.

  • StretchingBehavioural

    A twice-weekly stretching routine performed over 9 months (90-minute sessions), led by physiotherapists. This intervention provides low-intensity physical activity to control for physical engagement across study arms.

Study groups in NCT07042087
Study groupRoleWhat they receive
Mindfulness Yoga and Time-Restricted Eating InterventionExperimentalParticipants in this arm will take part in a 9-month intervention consisting of yoga-based mindfulness sessions combined with time-restricted eating (16:8 protocol). The yoga program includes physical postures (asanas), breathing techniques, and meditation, aimed at improving physical fitness, stress regulation, and cognitive function. The dietary component promotes a flexitarian diet within an 8-hour daily eating window. Sessions are conducted twice weekly for 90 minutes under certified instructors.
Receives: Behavioral: Mindfulness Yoga; Behavioral: Time-Restricted Eating with nutritional counseling promoting a flexitarian dietary pattern
Cognitive Training and Stretching InterventionActive comparatorParticipants in this arm will engage in a 9-month intervention including cognitive training exercises and guided stretching. The cognitive program targets multiple domains: verbal and non-verbal memory, executive functions, attention, language, and social cognition. Sessions are delivered twice weekly for 90 minutes by trained therapists. This intervention serves as an active comparator for assessing the effects of yoga and dietary modification on cognitive and biological outcomes.
Receives: Behavioral: Cognitive Training; Behavioral: Stretching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite Score of Cognitive Function

    Change in composite neuropsychological score from baseline to post-intervention (9 months), including domain-specific scores for memory, executive function/attention, and psychomotor speed.

    Measured: Baseline and 9 months

  2. Plasma Biomarkers of Neurodegeneration

    Change in concentrations of plasma biomarkers: phosphorylated tau (pTau217, pTau181), GFAP, and neurofilament light chain (NfL).

    Measured: Baseline and 9 months

Secondary outcomes (5)

  1. Computerized Cognitive Test Scores - Cogstate

    Change in individual and composite scores on computerized cognitive tests (e.g., Cogstate), including measures of spatial orientation.

    Measured: Baseline and 9 months

  2. Geriatric depression scale

    Changes in depression, using the GDS scale

    Measured: Baseline and 9 months

  3. Adherence to Intervention

    Attendance rate and adherence to prescribed intervention protocol (minimum attendance threshold and dietary compliance).

    Measured: Throughout the 9-month intervention

  4. Beck's anxiety inventory

    Anxiety levels measured by the BAI

    Measured: Baseline and 9 months

  5. Older People's Quality of Life Questionnaire scores

    Quality of life measured by OPQOL-35

    Measured: Time Frame: Baseline and 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2025
  2. Study start1 Nov 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07042087
Sponsor's protocol ID
16V/2024
Other IDs
101087124
Acronym
LIBRA REMIND
Status last verified
May 2025
First submitted
11 Jun 2025
Last updated
27 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness Yoga, Time-Restricted Eating with nutritional counseling promoting a flexitarian dietary pattern and Cognitive Training in people with Alzheimer Disease and Aging, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Score of Cognitive Function (time frame: Baseline and 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07042087.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.

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