Lifestyle for the BRAin Health - Nutrition and Exercise Training Intervention

Not Applicable

Recruiting

• Conditions: Aging; Alzheimer Disease; Life Style, Healthy; Exercise; Cognitive Impairment

• Registration Number: NCT06986096
• Lead Sponsor: Slovak Academy of Sciences

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, such as Alzheimer's disease.

The aim of the study is to assess the impact of a supervised 9-month intervention with aerobic-strength training and nutritional counseling compared to cognitive training and stretching on the brain, cognitive and motor functions, metabolism, physical fitnes and plasma markers of neurodegenertion in older adults at increased risk of developing Alzheimer's disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-15
• Study Start: 2024-09-01
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-15
• Study First Posted: 2025-05-22
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-29
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Impact on Cognitive Functions	Measurements at the baseline and after 9-month intervention.	Overall composite score of neuropsychological testing batery (higher score better outcome)
Effect of Interventions on Neurodegeneration Markers	Measurements at the baseline and after 9-month intervention	Concentration of plasma neurodegeneration marker pTau 217 (in a subpopulation of patients).

Secondary Outcome Measures

Name	Time	Method
Computerized Cognitive Tests	Measurements at the baseline and after 9-month intervention.	Computerised cognitive testing CogState (learning/working memory score, higher score - better outcome)
Well-being	Measurements at the baseline and after 9-month intervention.	The World Health Organization Quality of Life questionaire (WHOQOL-BREF), 31 items, highre score better QoL.
Glucose metabolism	Measurements at the baseline and after 9-month intervention.	oral glucose tolerance test will be perfromed to detect level of glucose intolerance (impaired glucose tolerance)
MRI of the Brain	Measurements at the baseline and after 9-month intervention.	Imaging studies to assess structural adaptation of the brain (hippocampal volume).
Adherence	Adherence will be recorded during the 9-month intervention period.	Evaluation of participant adherence to the intervention protocol.
Microbiome Composition	Measurements at baseline and after 9-month intervention.	Determination of feacal microbiome composition (16S sequencing).
Olfactory Function	Measurements at baseline and after 9-month intervention.	Olfactory function screening test (The Sniffin' Sticks test kit).

Trial Locations

Locations (1)

Biomedical Research Center Slovak Academy of Sciences; 🇸🇰 Bratislava, Slovakia