Longitudinal Multicenter Head-to-Head Harmonization of Tau PET Tracers
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 822
- 试验地点
- 18
- 主要终点
- Cross-sectional tau PET uptake values
研究概览
简要总结
The purpose of this study is to compare/harmonize cross-sectional and longitudinal tau tangle measurements obtained with the tau PET radiopharmaceuticals Flortaucipir and MK-6240 to elucidate the advantages and caveats of their use in clinical trials/practice and provide parameters to integrate their estimates.
详细描述
This is a longitudinal, multi-site, non-randomized study in which the participants will undergo Flortaucipir and MK-6240 PET scans at baseline and approximately at 18-month follow-up. At each time point, participants will also have an amyloid-β PET scan, magnetic resonance imaging, detailed cognitive tests, and a blood draw for biomarker quantification. The main objectives of this study are standardizing tau PET tracers' outcomes and comparing their performance.
To accomplish our objectives, the investigators propose the following specific aims:
In Aim 1, investigators will standardize tau PET processing methods, convert the tracers to a common scale, compare associations with amyloid-β, atrophy, and cognition, and compare/harmonize Braak staging assessments between tau tracers using cross-sectional data.
In Aim 2, investigators will ascertain the optimal processing method for longitudinal analysis and compare longitudinal changes in tau accumulation obtained with the tau PET radiopharmaceuticals and their associations with changes in amyloid-β, atrophy, and cognition.
In Exploratory Aim 3, investigators will compare cross-sectional and longitudinal Flortaucipir and MK-6240 estimates with plasma phosphorylated tau concentrations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a study partner who will be able to provide an independent evaluation of functioning.
- •Willing and capable of undergoing repeated MR/PET imaging.
- •Fluent in a language approved by the coordinating center.
- •At screening, must have no cognitive impairment, or meet criteria for single- or multiple-domain amnestic mild cognitive impairment or Alzheimer's disease dementia.
排除标准
- •Inability to provide informed consent by self or by proxy.
- •Pregnant or breastfeeding women.
- •Have any condition or are taking any medication that could increase the risk to the participant, limit the ability to tolerate or interfere with the results of the tests and procedures (in the opinion of the investigator).
研究组 & 干预措施
Individuals across the aging and Alzheimer's disease (AD) spectrum
All individuals enrolled into the HEAD study will undergo tau PET, amyloid-β PET, magnetic resonance imaging (MRI), detailed clinical and cognitive assessment, and a blood draw.
干预措施: 18F-MK-6240 radiopharmaceutical (Drug)
Individuals across the aging and Alzheimer's disease (AD) spectrum
All individuals enrolled into the HEAD study will undergo tau PET, amyloid-β PET, magnetic resonance imaging (MRI), detailed clinical and cognitive assessment, and a blood draw.
干预措施: 18F-Flortaucipir radiopharmaceutical (Drug)
Individuals across the aging and Alzheimer's disease (AD) spectrum
All individuals enrolled into the HEAD study will undergo tau PET, amyloid-β PET, magnetic resonance imaging (MRI), detailed clinical and cognitive assessment, and a blood draw.
干预措施: Amyloid-β radiopharmaceutical (11C-PiB or 18F-Florbetaben or 18F-NAV-4694 or 18F-Flutemetamol) (Drug)
结局指标
主要结局
Cross-sectional tau PET uptake values
时间窗: 2 years from enrollment
Compare/harmonize cross-sectional tau deposition measurements (standardized uptake value ratio (SUVR)) obtained with Flortaupicir and MK-6240.
Longitudinal change in tau PET uptake values over 18 months
时间窗: 5 years from enrollment
Compare/harmonize change in tau deposition measurements (standardized uptake value ratio (SUVR)) obtained with Flortaupicir and MK-6240 between baseline and 18-month follow-up assessments.
次要结局
- Associations of tau PET uptake values with amyloid-β PET uptake values(5 years from enrollment)
- Associations of tau PET uptake values with measures of cognition(5 years from enrollment)
- Associations of tau PET uptake values blood biomarkers(5 years from enrollment)
研究者
Tharick Pascoal
Associate Professor
University of Pittsburgh