Translational Neuroscience CAG for Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Understand which individual differences are observed among patients with Alzheimer's disease (AD).
研究概览
简要总结
Semantic AD
研究设计
- 研究类型
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 前瞻性
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- Confirmed diagnosis based on current ICD criteria for AD or MCI .
- >55years.
- Norwegian native speaker
- Lives at home and not in a health institution
排除标准
- Patients with severe cognitive impairment that prevents assessment with the selected modalities (planned cut-off: CDR > 2).
- Presence of brain tumors.
- History of traumatic brain injury.
- History of cranial surgery.
- Contraindications to the selected imaging modalities (e.g., 7T MRI or EEG).
- Diagnosis of other neurodegenerative diseases such as Parkinson's disease or ALS. 7T MRI contraindications:
- Large tattoos close to the head region, permanent makeup or unremoveable piercings
- Certain models of pacemakers (if pacemaker implantet, MRI physicist at 7T-lab will be conferred)
- Implantet metal in body (clips, stents, prothesis, skrews, plates, teeth etc.)
研究组 & 干预措施
Mild Alzheimer
Patients above 65 diagnosed with Alzheimer's Disease according to appropriate ICD-criterias.
干预措施: 7T MRI (Device)
Mild Alzheimer
Patients above 65 diagnosed with Alzheimer's Disease according to appropriate ICD-criterias.
干预措施: Blood samples (Biological)
Mild Alzheimer
Patients above 65 diagnosed with Alzheimer's Disease according to appropriate ICD-criterias.
干预措施: Stool samples (Biological)
Controls
Age- and gender-matched control group.
干预措施: Neuropsychologic test (MoCA) (Diagnostic Test)
Controls
Age- and gender-matched control group.
干预措施: 7T MRI (Device)
Controls
Age- and gender-matched control group.
干预措施: Blood samples (Biological)
Controls
Age- and gender-matched control group.
干预措施: EEG (Device)
Mild Alzheimer
Patients above 65 diagnosed with Alzheimer's Disease according to appropriate ICD-criterias.
干预措施: EEG (Device)
Mild Alzheimer
Patients above 65 diagnosed with Alzheimer's Disease according to appropriate ICD-criterias.
干预措施: Neuropsychologic test (MoCA) (Diagnostic Test)
Controls
Age- and gender-matched control group.
干预措施: Stool samples (Biological)
结局指标
主要结局
Understand which individual differences are observed among patients with Alzheimer's disease (AD).
时间窗: From enrollment to end of follow-up at 1 year.
This outcome will characterize individual variability among patients diagnosed with Alzheimer's disease based on clinical symptoms, cognitive assessments, neuroimaging findings (7T MRI), electrophysiological data (EEG), and biological samples (blood and stool). The goal is to identify patterns or subtypes that may reflect distinct disease mechanisms or progression profiles.
Compare changes in the brain, blood, and stool samples between dementia patients and healthy controls.
时间窗: From project enrollment to end of follow-up at 1 year.
Assess differences between dementia patients and cognitively healthy controls using multimodal data, including 7T MRI for brain structure, EEG, blood biomarkers, and gut microbiome profiles from stool samples. The aim is to identify biological and neurological markers associated with dementia-related changes.
次要结局
- Understand which individuals with mild cognitive impairment (MCI) go on to develop Alzheimer's disease (AD).(From enrollment to the end of follow-up time at 1 year.)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07118137
- 其他研究编号
- 490656
日期
- 首次提交
- (去年)
- 首次发布
- (去年)
- 主要完成日期
- (明年)
- 研究完成日期
- (明年)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
All data will be anonymized.