Neurodegeneration and Neuronal Fluctuations in Lewy Body Disease and Alzheimer Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Electroencephalography (EEG)
研究概览
简要总结
The purpose of this research study is to investigate how the brain, memory, thinking, and motor behavior change both in individuals with movement and/or cognitive disorders, as well as healthy individuals. Researchers will look at measurements of memory, thinking, brain wave and muscle activity, daily functioning, and brain scans to learn more about brain disorders such as Alzheimer disease and Lewy body disease.
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
- 50 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Use English as their primary language.
- •Be willing to undergo health and cognitive assessments, as well as brain MRI and EEG study.
- •Will be encouraged to have an available study partner (also called a "co-participant") who is familiar with the participant's daily functioning.
- •This study will be limited to healthy individuals, and patients who have a clinical diagnosis made by a board-certified neurologist of Lewy body disease or Alzheimer disease.
- •All individuals must be capable of providing informed consent and complying with the trial procedures. Realizing the challenge of obtaining informed consent from cognitively impaired individuals, time is specifically scheduled to foster an informative, supportive interview with the participant and caregiver/legal guardian (typically a spouse or child according to Arizona law and IRB guidelines).
- •Ongoing participation will be maintained by strict adherence to inclusion/
排除标准
- •, clinical appropriateness (as determined by participant's physician and proxy/family), as well as by expressed wishes of family members/caregivers/proxy discussed at each study visit (as appropriate).
- •All participants will receive copies of the signed ICFs (including signatures of those obtaining consent).
- •All participants have the right to withdraw from the study at any time.
- •Exclusion Criteria:
- •Individuals will be excluded if they have significant sensory (visual and hearing) deficits or major medical or psychiatric illnesses which would limit participation.
- •Participants will also be excluded if they have history of other major neurologic disorders including stroke, epilepsy, meningitis/encephalitis, metabolic or toxic encephalopathy, penetrating or severe closed head injury, brain tumor/other structural lesion, other primary movement disorders (such as essential tremor, dystonia, chorea, multiple system atrophy, progressive supranuclear palsy, corticobasal syndrome).
- •In addition, as necessitated by the risks of Magnetic Resonance Imaging (MRI), patients who have any type of implanted electrical device (such as a cardiac pacemaker or a neurostimulator including deep brain stimulation), or a certain type of metallic clip in their body (i.e., an aneurysm clip in the brain), are not eligible for participation in the MRI portion of the study. Individuals who experience claustrophobic anxiety will also be excluded from participation.
- •Women who are or might be pregnant and nursing mothers are not eligible.
- •If the subject is a woman of childbearing potential, due to unknown risks to the fetus, they must have a pregnancy test. Individuals who have a history metalworking involving cutting processes such as grinding, filing, shaving, and threading, or history of eye injury involving metal, will also be excluded unless they have had prior documented radiological clearance for MRI.
研究组 & 干预措施
Alzheimer Disease Group
Subjects identified by their physician with a diagnosis of Alzheimer will have a physical and neurological exam, MRI of brain, electroencephalography (EEG), and electromyography (EMG).
干预措施: Electroencephalography (Diagnostic Test)
Lewy Body Disease Group
Subjects identified by their physician with a diagnosis of Lewy body disease will have a physical and neurological exam, MRI of brain, electroencephalography (EEG), and electromyography (EMG).
干预措施: Magnetic Resonance Imaging (Diagnostic Test)
Lewy Body Disease Group
Subjects identified by their physician with a diagnosis of Lewy body disease will have a physical and neurological exam, MRI of brain, electroencephalography (EEG), and electromyography (EMG).
干预措施: Electroencephalography (Diagnostic Test)
Lewy Body Disease Group
Subjects identified by their physician with a diagnosis of Lewy body disease will have a physical and neurological exam, MRI of brain, electroencephalography (EEG), and electromyography (EMG).
干预措施: Electromyography (Diagnostic Test)
Alzheimer Disease Group
Subjects identified by their physician with a diagnosis of Alzheimer will have a physical and neurological exam, MRI of brain, electroencephalography (EEG), and electromyography (EMG).
干预措施: Magnetic Resonance Imaging (Diagnostic Test)
Alzheimer Disease Group
Subjects identified by their physician with a diagnosis of Alzheimer will have a physical and neurological exam, MRI of brain, electroencephalography (EEG), and electromyography (EMG).
干预措施: Electromyography (Diagnostic Test)
Healthy Control Group
Subjects identified as a health individual will have a physical and neurological exam, MRI of brain, electroencephalography (EEG), and electromyography (EMG).
干预措施: Magnetic Resonance Imaging (Diagnostic Test)
Healthy Control Group
Subjects identified as a health individual will have a physical and neurological exam, MRI of brain, electroencephalography (EEG), and electromyography (EMG).
干预措施: Electroencephalography (Diagnostic Test)
Healthy Control Group
Subjects identified as a health individual will have a physical and neurological exam, MRI of brain, electroencephalography (EEG), and electromyography (EMG).
干预措施: Electromyography (Diagnostic Test)
结局指标
主要结局
Electroencephalography (EEG)
时间窗: Baseline
Measures brain-wave activity
Diffusion-weighted MRI (dMRI)
时间窗: Baseline
Measures diffusion of water molecules and cellular-level constraints
次要结局
未报告次要终点
研究者
Shannon Y. Chiu
Principal Investigator
Mayo Clinic