Investigating the Potential of Novel Dementia Biomarkers - an MRI, fNIRS and EEG Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- Performance on verbal fluency test
研究概览
简要总结
The study will investigate structural and functional characteristics of the brain of dementia patients compared to healthy controls in order to get a better insight into importance of early biomarkers for the diagnosis of Alzheimer's dementia. The methods for obtaining biomarkers incude magnetic resonance imaging (MRI), near-infrared spectroscopy (fNIRS) and electroencephalography (EEG), electrocardiography (ECG) and neurophyshological assessments. Special parameters are being studied that have already been shown to detect changes in the early stages of Alzheimer's dementia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinically diagnosed MCI patients and matched healthy controls
排除标准
- •Metal in body and tatoos;
- •Other chronic systemic neurological, cardiologic, metabolic or musculo-skeletal diseases which have been proven to influence the outcome variables
- •Alcohol abuse
- •Colour blindness
- •Pregnancy
- •Surgery in the last 6 months
- •Uncorrected vision
结局指标
主要结局
Performance on verbal fluency test
时间窗: 10 minutes
Test of verbal fluency, more words spoken means a better score
Heart Rate Variability (HRV)
时间窗: 1 hour
ECG-based variability measures in R-R intervals, both in rest abd during tasks
Locus Coeruleus (LC) Intensity
时间窗: 15 minutes
LC-intensity can be assesed with specific MRI sequences (TSE MRI-Sequence (see Dordevic et al, 2017))
Error-rate on Stroop-test
时间窗: 10 minutes
Test of executive functions, higher error-rate means worse performance
Event-related-potential (ERP) waveforms: negative deflections (N100, N300) and positive deflections (P100, P300)
时间窗: 1 hour
Voltages generated in the brain structures in response to specific events (Event-related potentials (ERPs))
Volume of brain regions
时间窗: 30 minutes
VBM (voxel-based morphometry)
fNIRS-based change in oxyhemoglobin and deoxyhemoglobin
时间窗: 1 hour
In response to each task there is a hemodynamic response, which can be measured by fNIRS. In particular, fNIRS measures changes in blood oxy- and deoxy-hemoglobin.
Score on CERAD-Plus
时间窗: 30 minutes
Cognitive performance measure in points, with a higher score meaning better performance
Error-rate on N-Back-test
时间窗: 10 minutes
Working memory test, higher error-rate means worse performance
次要结局
未报告次要终点
研究者
Notger Müller
Professor Dr. Notger Müller
German Center for Neurodegenerative Diseases (DZNE)