Aging, Alzheimer Disease, Cognitive Impairment, Diet Modification, Lifestyle Factors, Time Restricted Eating, Yoga
Conditions
Keywords
Alzheimer's Disease Prevention, Mindfulness-Based Intervention, Cognitive Training, Time-Restricted Eating, Dietary consultation
Brief 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 Alzheimer's disease.
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.
Interventions
BEHAVIORALMindfulness Yoga
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.
BEHAVIORALTime-Restricted Eating with nutritional counseling promoting a flexitarian dietary pattern
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.
BEHAVIORALCognitive Training
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.
BEHAVIORALStretching
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.
Sponsors
Slovak Academy of Sciences
St. Anne's University Hospital Brno, Czech Republic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Score of Cognitive Function | 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 | Baseline and 9 months | Change in concentrations of plasma biomarkers: phosphorylated tau (pTau217, pTau181), GFAP, and neurofilament light chain (NfL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Intervention | Throughout the 9-month intervention | Attendance rate and adherence to prescribed intervention protocol (minimum attendance threshold and dietary compliance). |
| Computerized Cognitive Test Scores - Cogstate | Baseline and 9 months | Change in individual and composite scores on computerized cognitive tests (e.g., Cogstate), including measures of spatial orientation. |
| Older People's Quality of Life Questionnaire scores | Time Frame: Baseline and 9 months | Quality of life measured by OPQOL-35 |
| Beck's anxiety inventory | Baseline and 9 months | Anxiety levels measured by the BAI |
| Geriatric depression scale | Baseline and 9 months | Changes in depression, using the GDS scale |
Countries
Czechia
Outcome results
None listed