Status:
RECRUITING
Lifestyle for the BRAin Health - Nutrition and Exercise Training Intervention
Lead Sponsor:
Slovak Academy of Sciences
Conditions:
Aging
Alzheimer Disease
Eligibility:
All Genders
60-80 years
Phase:
NA
Brief Summary
Due to the increasing incidence of dementia and the lack of causal treatment, non-pharmacological interventions represent an attractive and effective therapeutic strategy of neurodegenerative diseases...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06986096
Start Date
September 1 2024
End Date
December 1 2026
Last Update
May 29 2025
Active Locations (1)
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1
Biomedical Research Center Slovak Academy of Sciences
Bratislava, Bratislava Region, Slovakia, 84505