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| ID | Type | Description | Link |
|---|---|---|---|
| 101087124 | Other Grant/Funding Number | Horizon EU |
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| Name | Class |
|---|---|
| Slovak Academy of Sciences | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Yoga and Time-Restricted Eating Intervention | Experimental | Participants 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. |
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| Cognitive Training and Stretching Intervention | Active Comparator | Participants 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Yoga | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 9 months |
| Plasma Biomarkers of Neurodegeneration | Change in concentrations of plasma biomarkers: phosphorylated tau (pTau217, pTau181), GFAP, and neurofilament light chain (NfL). | Baseline and 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Computerized Cognitive Test Scores - Cogstate | Change in individual and composite scores on computerized cognitive tests (e.g., Cogstate), including measures of spatial orientation. | Baseline and 9 months |
| Geriatric depression scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kateřina Sheardova, MD. PhD. | The International Clinical Research Center of St. Anne's University Hospital in Brno (FNUSA-ICRC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fnusa/ Icrc | Recruiting | Brno | 64400 | Czechia |
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| Time-Restricted Eating with nutritional counseling promoting a flexitarian dietary pattern | Behavioral | 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. |
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| Cognitive Training | Behavioral | 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. |
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| Stretching | Behavioral | 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. |
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Changes in depression, using the GDS scale
| Baseline and 9 months |
| Adherence to Intervention | Attendance rate and adherence to prescribed intervention protocol (minimum attendance threshold and dietary compliance). | Throughout the 9-month intervention |
| Beck's anxiety inventory | Anxiety levels measured by the BAI | Baseline and 9 months |
| Older People's Quality of Life Questionnaire scores | Quality of life measured by OPQOL-35 | Time Frame: Baseline and 9 months |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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