NCT04002583进行中（未招募）不适用
A Prospective Study Evaluating the Use of 48-hour Ambulatory EEG Monitoring in Early Onset Alzheimer's Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Electrographic seizures: Number of subjects with electrographic seizures
研究概览
简要总结
Researchers are trying to determine the frequency of seizures and epilepsy in patients with Early-onset Alzheimer's disease (EOAD) using a 48-hour computer assisted ambulatory electroencephalogram.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for EOAD patients will be recruited from the LEADS trial with the following:
- •40 to 64 years of age
- •Meets NIA-AA criteria for mild cognitive impairment (MCI) due to AD or probable AD dementia.
- •Have a global CDR score of ≤ 1.0
- •Have capacity to provide informed consent (ICF) or has a legal authorized representative or guardian who provides IC.
- •Amyloid positive status (PET scan with evidence of elevated amyloid)
- •Must have a study partner (informant) who spends a minimum average of 10 hours per week with the participant (e.g., family member, significant other, friend, and caregiver) who is generally aware of the participants' daily activities and can provide information about the participant's cognitive and functional performance. If the participant does not have a study partner who spends 10 face-to-face hours per week, other arrangements for identifying a viable study partner will be granted on a case-by-case basis by the Site PI.
- •Not pregnant or lactating. Women must be two years post-menopausal, be surgically sterile, or have a negative pregnancy test prior to each PET scan
- •Fluent in English.
排除标准
- •Meets core clinical criteria for non-AD dementia.
- •Two or more first degree relatives with a history of EOAD suggestive of autosomal dominant transmission, unless known pathogenic mutations in APP, PSEN1, PSEN2 have been excluded.
- •Known mutation in an ADAD gene (APP, PSEN1, PSEN2) or other autosomal dominant genes associated with other neurodegenerative disorders.
- •MRI scans with evidence of infection or focal lesions, cortical strokes, multiple lacunes (single lacune is allowable unless it meets criteria for strategic lacune affecting cognition)
- •Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol (at the discretion of the Site PI)
- •Medical history of a brain disorder other than the disorder causing dementia except for headache.
- •Deemed ineligible by the Site PI for any other reason.
研究组 & 干预措施
Early-onset Alzheimer's disease (EOAD) subjects
Experimental
Subjects with mild cognitive impairment due to EOAD will undergo a 48 hour computer assisted ambulatory electroencephalogram
干预措施: Computer assisted ambulatory electroencephalogram (Diagnostic Test)
结局指标
主要结局
Electrographic seizures: Number of subjects with electrographic seizures
时间窗: 48 hours
Number of subjects with electrographic seizures in 48 hours on computer assisted ambulatory EEG
次要结局
未报告次要终点
研究者
Neill R. Graff-Radford, M.D.
Principal Investigator
Mayo Clinic
研究点 (1)
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