Lifestyle for the BRAin Health - Nutrition and Exercise Training Intervention, LIBRA-NET
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Impact on Cognitive Functions
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
ID codes will be provided for the outcomes assessor, without group-specific characterization
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Impact on Cognitive Functions
时间窗: 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
时间窗: Measurements at the baseline and after 9-month intervention
Concentration of plasma neurodegeneration marker pTau 217 (in a subpopulation of patients).
次要结局
- Computerized Cognitive Tests(Measurements at the baseline and after 9-month intervention.)
- Well-being(Measurements at the baseline and after 9-month intervention.)
- Glucose metabolism(Measurements at the baseline and after 9-month intervention.)
- MRI of the Brain(Measurements at the baseline and after 9-month intervention.)
- Adherence(Adherence will be recorded during the 9-month intervention period.)
- Olfactory Function(Measurements at baseline and after 9-month intervention.)
- Microbiome Composition(Measurements at baseline and after 9-month intervention.)
研究者
Barbara Ukropcová, MD, PhD
Professor
Slovak Academy of Sciences