Multimodal Assessment of Cognitive Impairment in Alzheimer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- AD-subclassification
研究概览
简要总结
The goal of this study is to learn more about the changes in the brains of patients with cognitive impairment (MCI) and Alzheimer's Disease (AD).
The main questions the study aims to answer are:
- What findings can be used to earlier detect patients that will develop Alzheimers?
- Which differences are seen between healthy and cognitively impaired patients?
- Which differences are seen between patients with Alzheimers disease?
Participants will undergo:
- Cognitive tests
- Magnetic resonance imaging (MRI)
- Electroencephalography (EEG)
- Blood sample collection
- Fecal sample collection
- A randomized group will undergo polysomnography analysis.
详细描述
The projects aims to map brain changes in patients with mild cognitive impairment (MCI) and Alzheimer's Disease (AD) by combining different assesment modalities.
In the MRI, researchers will get the opportunity to analyse both structural and functional brain changes. In the EEG, changes in elctrical activites will be measured. The blood samples allow researchers to analyse specific dementia and inflammation proteins, while fecal speciments can be used to assess bacterial composition. Additionally, the cognitive testing allow to assess the specific part of cognitive function which is affected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •MCI and AD according to relevant ICD-criterias.
- •Control cohort is age and gender matched with other cohorts.
排除标准
- •Uneligibility for any of the planned neuroimagery devices (MRI, EEG)
- •AD diagnosis before the age of 65 (Early-onset AD).
- •Brain tumor
- •Traumtic head injury
- •Earlier neurosurgery
- •Other neyrodegenerative diseases (i.e Parkinson and ALS)
- •Diseases related to inflammation and auto-immunity (i.e MS)
研究组 & 干预措施
MCI
Recruitment according to relevant clinical assessment and ICD-criterias.
干预措施: MRI Scanning (Device)
MCI
Recruitment according to relevant clinical assessment and ICD-criterias.
干预措施: Polysomnography (Device)
MCI
Recruitment according to relevant clinical assessment and ICD-criterias.
干预措施: Fecal samples (Biological)
Mild AD
Recruitment according to relevant clinical assessment and ICD-criterias.
干预措施: Blood samples (Biological)
Mild AD
Recruitment according to relevant clinical assessment and ICD-criterias.
干预措施: Cognitive tests (Behavioral)
Control
Equivalent number of research participants as in the MCI and mild AD group.
干预措施: Fecal samples (Biological)
Control
Equivalent number of research participants as in the MCI and mild AD group.
干预措施: Cognitive tests (Behavioral)
MCI
Recruitment according to relevant clinical assessment and ICD-criterias.
干预措施: 64-channel EEG (Device)
MCI
Recruitment according to relevant clinical assessment and ICD-criterias.
干预措施: Cognitive tests (Behavioral)
Mild AD
Recruitment according to relevant clinical assessment and ICD-criterias.
干预措施: MRI Scanning (Device)
Mild AD
Recruitment according to relevant clinical assessment and ICD-criterias.
干预措施: Polysomnography (Device)
Mild AD
Recruitment according to relevant clinical assessment and ICD-criterias.
干预措施: Fecal samples (Biological)
MCI
Recruitment according to relevant clinical assessment and ICD-criterias.
干预措施: Blood samples (Biological)
Control
Equivalent number of research participants as in the MCI and mild AD group.
干预措施: 64-channel EEG (Device)
Control
Equivalent number of research participants as in the MCI and mild AD group.
干预措施: Polysomnography (Device)
Control
Equivalent number of research participants as in the MCI and mild AD group.
干预措施: Blood samples (Biological)
Mild AD
Recruitment according to relevant clinical assessment and ICD-criterias.
干预措施: 64-channel EEG (Device)
Control
Equivalent number of research participants as in the MCI and mild AD group.
干预措施: MRI Scanning (Device)
结局指标
主要结局
AD-subclassification
时间窗: 5 years
Identify biomarker profiles that can assist in a more thorough AD-classification
MCI-AD converters
时间窗: 5 years
Identify biomarker profiles unique for patients with MCI that develop AD for earlier prediction.
次要结局
未报告次要终点