Multimodal Imaging in Alzheimer's Disease and Other Neurodegenerative Diseases
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Spatial disorientation
研究概览
简要总结
The purpose of this study is to investigate whether markers of brain structure and function from MRI are associated with different levels of spatial orientation and gait parameters in people with mild cognitive impairment or dementia due to Alzheimer's disease when walking through a real world environment.
详细描述
This is an experimental cross-sectional study which primarily aims at identifying characteristic features of spatial disorientation among people with mild cognitive impairment and dementia. The features of interest are motion and physiological related changes that occur during instances of spatial disorientation, which will be derived from wearable sensors.
Additionally, brain structure and functional connectivity changes associated with different levels of spatial orientation and gait parameters will also be investigated through resting-state functional imaging.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •50 years and above
- •Mini mental state examination (MMSE) ≥ 12 < 28 points for experimental group
- •Mini mental state examination (MMSE) ≥ 28 points for control group
- •Sufficient knowledge of German to understand participant information, declaration of consent and questionnaires
- •Dated and signed declaration of consent
- •Sufficient mobility and motivation to participate in the study
排除标准
- •Less than 50 years
- •Significantly impaired vision or hearing
- •Severely reduced mobility: cannot move around independently (even with aids)
结局指标
主要结局
Spatial disorientation
时间窗: Up to 3 years from start of the study
Incidences of disorientation will be annotated in real-time using a customized annotation scheme in the pocket observer software
次要结局
- Heart rate variability(Up to 3 years from start of the study)
- Skin conductance(Up to 3 years from start of the study)
- Accelerometry(Up to 3 years from start of the study)
- Grey matter volume(Up to 3 years from start of the study)
- White matter integrity(Up to 3 years from start of the study)
- Resting-state functional connectivity(Up to 3 years from start of the study)
- Interview responses(Up to 3 years from start of the study)
研究者
Stefan Teipel
Prof. Dr. med
University Medical Center Rostock