CLearing Alzheimer's Disease Molecular Pathology Without Medications
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- Changes in amyloid load
研究概览
简要总结
According to the most popular pathophysiological models of Alzheimer's disease, the amyloid hypothesis, amyloid deposition is the causative event triggering a chain of other downstream events which finally lead to Alzheimer's disease and dementia. In mouse models of Alzheimer's disease, 40 Hz multi-sensory (auditory and visual) stimulation was able to reduce the number and size of amyloid plaques throughout cortex and improve cognitive performance.
The primary objective of this study is to assess whether an intervention consisting of 40 Hz multi-sensory (auditory and visual) stimulation is able to reduce the amyloid load in non-demented amyloid-positive individuals.
As secondary objectives, the investigators will assess whether such intervention is able to:
- improve the brain electrical activity,
- improve or slow down the worsening of Alzheimer's blood-based biomarkers,
- improve or slow down the worsening of cognition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed Consent as documented by signature (Appendix Informed Consent Form),
- •age 40-80,
- •≥5 years of education,
- •previous evidence of brain amyloidosis (assessed by PET, CSF, or blood-based biomarkers).
排除标准
- •history of epilepsy;
- •clinically relevant visual or auditory diseases/deficits;
- •clinical diagnosis of dementia;
- •contraindication to amyloid-PET;
- •inability to undergo the procedures of the study, e.g. severe behavioral disturbances;
- •severe diseases:
- •Malignant neoplasm within 5 years,
- •Life threatening diseases,
- •Severe systemic diseases (e.g. kidney insufficiency, cardiac insufficiency, decompensated diabetes, decompensated metabolic diseases, decompensated hypothyroidism, uncontrolled autoimmune diseases);
- •the participation to a clinical trial involving potential Alzheimer's disease modifying therapies;
- •documented pregnancy or intention to become pregnant during the course of the study or breast feeding.
结局指标
主要结局
Changes in amyloid load
时间窗: 8 weeks
Changes in amyloid load assessed by longitudinal amyloid-PET
次要结局
- Changes in brain electrical activity(8 weeks)
- Changes in Alzheimer's blood-based biomarkers(8 weeks)
- Changes in cognition(8 weeks)
研究者
Daniele Altomare
Principal Investigator
University Hospital, Geneva