Molecular and Structural Imaging in Alzheimer's Disease: A Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Amount of Tau protein in the brain of patients with Logopenic Aphasia (LPA) or Posterior Cortical Atrophy (PCA).
研究概览
简要总结
This is a neuroimaging study designed to learn more about amyloid and tau burden in the brain of patients with typical and atypical Alzheimer's Disease and how burden may change over a one year period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over the age of 21
- •Must have an informant who will be able to provide independent evaluation of functioning
- •English is primary language
- •All subjects must have insidious onset, report progression of their symptoms, and meet current clinical diagnostic criteria for typical amnestic AD or an atypical AD syndrome such as Logopenic Aphasia (LPA) or Posterior Cortical Atrophy (PCA).
- •All subjects with Logopenic Aphasia (LPA) must present with early and dominant impairments in language
- •All subjects with typical amnestic AD must have relative preservation of episodic memory compared to impairment in the non-episodic memory domain
排除标准
- •If you have had a stroke or tumor that could explain your symptoms
- •Subjects that present with early episodic memory impairment or meet clinical criteria for mild cognitive impairment will not be recruited into the study
- •Subjects that meet specific criteria for another neurodegenerative disorder, including behavioral variant frontotemporal dementia, semantic dementia, primary progressive apraxia of speech, probable corticobasal syndrome, or progressive supranuclear palsy, will be excluded
- •Subjects will be excluded if they have poor vision (20/400)
- •Women that are pregnant or post-partum and breast-feeding will be excluded
- •Subjects will be excluded from the study if they are unable to undergo the tau-PET scan due to a prolonged QT interval on ECG, or if they have any of the following genetic conditions which can increase the chance of cancer: Cowden disease, Lynch syndrome, hypogammaglobulinemia, Wiskott-Aldrich syndrome, and Down's syndrome
- •Subjects will also be excluded if MRI is contraindicated (metal in head, cardiac pace maker, e.t.c.), if there is severe claustrophobia, if there are conditions that may confound brain imaging studies (e.g. structural abnormalities, including subdural hematoma or intracranial neoplasm), or if they are medically unstable or are on medications that might affect brain structure or metabolism,(e.g. chemotherapy)
研究组 & 干预措施
Tau PET Scan, F-18 AV 1451
All subjects will receive two Tau PET scans during this study.
干预措施: C-11 PiB (Drug)
PiB PET Scan, C-11 PiB
All subjects will receive two PiB PET scans during this study.
干预措施: C-11 PiB (Drug)
Tau PET Scan, F-18 AV 1451
All subjects will receive two Tau PET scans during this study.
干预措施: F-18 AV 1451 (Drug)
PiB PET Scan, C-11 PiB
All subjects will receive two PiB PET scans during this study.
干预措施: F-18 AV 1451 (Drug)
结局指标
主要结局
Amount of Tau protein in the brain of patients with Logopenic Aphasia (LPA) or Posterior Cortical Atrophy (PCA).
时间窗: 5 years
Amount of Amyloid protein in the brain of patients with Logopenic Aphasia (LPA) or Posterior Cortical Atrophy (PCA).
时间窗: 5 years
次要结局
- Rates of change in amyloid-PET burden over time.(baseline, 1 year)
- Rates of change in tau-PET burden over time.(baseline, 1 year)
研究者
Jennifer Whitwell
Associate Professor of Radiology
Mayo Clinic