Alzheimer's Plasma Extension
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 3,000
- 试验地点
- 110
- 主要终点
- Rate of change from Baseline to Month 48 on plasma phosphorylated tau (ptau) 217
研究概览
简要总结
The goal of this observational study is to learn how Alzheimer's disease-related blood biomarkers, brain amyloid, and memory and thinking abilities change over time. The study will include up to 3,000 people who previously did not qualify for an anti-amyloid Alzheimer's disease prevention trial based on their amyloid eligibility. Participants may have previously screened for the AHEAD 3-45 Study, A4 Study, or another anti-amyloid Alzheimer's disease prevention trial.
The main questions this study aims to answer are:
- Can Alzheimer's disease-related blood tests help predict future buildup of amyloid in the brain?
- How are changes in Alzheimer's disease-related blood biomarkers related to changes in brain amyloid, memory, thinking, and self-reported cognitive function?
- Do these changes differ based on factors such as sex, APOE genetic status, race, ethnicity, socioeconomic status, or social factors?
Participants will be followed for about 6 years. They will complete memory and thinking assessments and questionnaires and provide blood samples. Some participants may also be asked to take part in optional activities, including brain imaging with positron emission tomography (PET) or magnetic resonance imaging (MRI), digital cognitive assessments, and questionnaires about habits and social factors.
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
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Documentation of the participant's informed consent to study procedures and for the use of protected health information (HIPAA Authorization, or local, regional or country-specific equivalent). Informed consent processes and documentation must adhere to state laws/local requirements, including consent provided by the participant's legally authorized representative (LAR), responsible next of kin, surrogate consent with assent, etc.
- •Previously consented to participate in an anti-amyloid preclinical AD study (e.g., AHEAD 3-45, A4 or other anti-amyloid preclinical AD study).
- •Has screening results that did not meet amyloid eligibility criteria for an anti-amyloid preclinical AD trial (e.g., AHEAD 3-45, A4, or other anti-amyloid preclinical AD study).
- •As assessed by the site PI, participant is likely to be able to comply with the protocol, including completion of all required procedures for the duration of the study, and has adequate vision, hearing (hearing aid permitted), and literacy in English or Spanish sufficient for compliance with required testing procedures.
- •For participants who screen failed from the AHEAD 3-45 Study:
- •Has AHEAD 3-45 screening plasma biomarker results required for determining eligibility to participate in the AHEAD 3-45 Study.
排除标准
- •Current treatment with an FDA approved medication for Alzheimer's disease, including prior or current treatment with a prohibited medication.
- •Enrollment in another investigational study, or intake of investigational drug, within 30 days prior to screening, or five half-lives of the investigational drug, whichever is longer, unless it can be documented that the participant was in the placebo treatment arm.
- •Screen failed from an anti-amyloid preclinical AD trial (e.g. AHEAD 3-45, A4 or other anti-amyloid preclinical AD trial) due to not meeting basic inclusion criteria (i.e., age requirement; current diagnosis of AD dementia).
- •For participants participating in the optional amyloid PET imaging sub-study:
- •Is pregnant or breastfeeding.
结局指标
主要结局
Rate of change from Baseline to Month 48 on plasma phosphorylated tau (ptau) 217
时间窗: Baseline, Month 12, Month 24, Month 36 and Month 48
Assess longitudinal changes from initial visit in plasma phosphorylated tau (ptau) 217 ratio using a proteomics assay
Rate of change from Baseline to Month 48 on plasma beta-amyloid (Aβ) 40 or 42 ratio
时间窗: Baseline, Month 12, Month 24, Month 36 and Month 48
Rate of change from Baseline through Month 72 in plasma beta-amyloid (Aβ) 40 or 42 ratio
时间窗: Baseline, Month 12, Month 24, Month 36, Month 48, Month 60, and Month 72
Change in plasma Aβ42/Aβ40 ratio over the longitudinal follow-up period will be assessed using repeated blood-based biomarker measurements.
Rate of change from Baseline through Month 72 in plasma phosphorylated tau (ptau) 217
时间窗: Baseline, Month 12, Month 24, Month 36, Month 48, Month 60, and Month 72
Assess longitudinal changes from initial visit in plasma phosphorylated tau (ptau) 217 ratio using a proteomics assay
次要结局
- Rate of Change from Baseline to Month 48 as measured Cognitive Function Index (CFI)(Baseline, Month 12, Month 24, Month 36 and Month 48)
- Rate of Change from Baseline to Month 48 as measured by the Preclinical Alzheimer Cognitive Composite 5(PACC5)(Baseline, Month 12, Month 24, Month 36 and Month 48)
- Rate of Change from Baseline through Month 72 as measured by the Preclinical Alzheimer Cognitive Composite 5 (PACC5)(Baseline, Month 12, Month 24, Month 36, Month 48, Month 60, and Month 72)
- Rate of Change from Baseline through Month 72 as measured Cognitive Function Index (CFI)(Baseline, Month 12, Month 24, Month 36, Month 48, Month 60, and Month 72)
研究者
Paul S. Aisen
Professor
University of Southern California