About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Mindfulness Yoga
BehavioralA 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 pattern
BehavioralParticipants 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 Training
BehavioralA 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.
Stretching
BehavioralA 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Plasma Biomarkers of Neurodegeneration
Change in concentrations of plasma biomarkers: phosphorylated tau (pTau217, pTau181), GFAP, and neurofilament light chain (NfL).
Secondary outcomes
Computerized Cognitive Test Scores - Cogstate
Change in individual and composite scores on computerized cognitive tests (e.g., Cogstate), including measures of spatial orientation.
Geriatric depression scale
Changes in depression, using the GDS scale
Adherence to Intervention
Attendance rate and adherence to prescribed intervention protocol (minimum attendance threshold and dietary compliance).
Beck's anxiety inventory
Anxiety levels measured by the BAI
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
St. Anne's University Hospital Brno, Czech Republic
Lead sponsor
Slovak Academy of Sciences
Collaborator