NCT06986096 · RECRUITING
Lifestyle for the BRAin Health - Nutrition and Exercise Training Intervention
This trial compares two nine-month supervised programs in older adults at higher risk for Alzheimer's. One combines aerobic and strength training with nutrition counseling. The other combines cognitive training with stretching. Researchers will measure brain scans, thinking, movement, metabolism, fitness and blood markers. It is a behavioral study with no drug and no phase, so it tests effects, not a proven approach.
You may qualify if
- Non-smokers
- Signed informed consent
- Presence of subjective or mild cognitive impairment (SCI/aMCI)
- Elevated levels of selected biomarkers confirming the presence of a pathological process characteristic of Alzheimer's disease
- Absence of any psychological, sociological, or geographical factors that could jeopardize participation in the project.
You're excluded if
- Presence of severe cardiovascular, liver, or kidney diseases; advanced or poorly controlled diabetes mellitus (HbA1c >7%), treated with insulin or incretin analogs; cancer or any other severe disease as assessed by the responsible physician. A history of cancer treated with chemotherapy or radiotherapy if within less than 5 years post-treatment.
- Lack of cooperation, inflexible schedule, or problematic transportation.
- Insufficient functional capacity or presence of comorbidities that prevent participation in the training program (assessment by an internist, cardiologist, neurologist, orthopedic specialist, or other relevant specialists).
- Presence of a pacemaker or any metal implants (contraindication for MRI examination), or allergy to local anesthetics (contraindication for muscle biopsy).
- Smoking, alcohol dependence, or addiction to other narcotic substances.
- Stroke or myocardial infarction within the last year.
- Long-term treatment for psychiatric disorders - a depressive syndrome is not an exclusion criterion if it is compensated by therapy.
- Other diseases of the musculoskeletal or nervous system that potentially interfere with the ability to exercise or cognition - such as severe arthritis, Parkinson's disease, significant essential tremor, epilepsy, etc.
- Concurrent participation in another clinical study.
- Therapy with cholinesterase inhibitors unless the patient is on a stable dose.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-05-29