NCT07752784招募中3 期
A Clinicopathological Study to Evaluate the Concordance Between [18F]-APN-1607 Injection PET Imaging and Post-mortem Brain Tau Protein Pathological Changes in Cognitively Normal (HV) Subjects and Patients With AD-derived Mild Cognitive Impairment (MCI) or Alzheimer's Disease (AD) Dementia.
JYAMS PET Research & Development Limited1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2026年8月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Evaluate the consistency between the visual interpretation results of [18F]-APN-1607 injection PET imaging and the authenticity standards.
研究概览
简要总结
- To evaluate the diagnostic performance of [18F]-APN-1607 injection PET imaging in detecting uptake patterns consistent with AD neuropathological changes as defined by the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria.
- To assess the association between [18F]-APN-1607 injection and Alzheimer's disease (AD)-related tau neurofibrillary pathology (as determined by post-mortem brain tissue histopathology), and detect the uptake pattern corresponding to neurofibrillary tangle (NFT) scores.
- To evaluate the safety of [18F]-APN-1607 injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to understand and voluntarily sign a written informed consent form (ICF).
- •Age≥50 years, male or female.
- •Charlson Comorbidity Index (CCI)≥
- •Able to tolerate imaging procedures.
- •For MCI or AD subjects: clinically diagnosed as AD-derived cognitive impairment or Alzheimer's dementia.
- •For HV subjects: no known personal or family history of AD-derived dementia.
排除标准
- •Confirmed brain structural abnormalities that may affect PET reading, e.g., large stroke (infarct area>4 cm) or intracranial space-occupying lesion.
- •Currently having clinically significant infectious diseases: HIV, hepatitis, etc.
- •Currently participating in any investigational clinical trial.
- •Previous participation in clinical studies of amyloid or tau-targeting agents.
- •Suspected hepatic encephalopathy.
- •Allergy to the investigational drug or any of its components.
- •Currently pregnant or breastfeeding.
- •Currently having a disease or condition that prolongs the QT interval.
研究组 & 干预措施
Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI)
Experimental
Alzheimer's Disease or Mild Cognitive Impairment subjects will undergo PET imaging using [18F]-APN-1607
干预措施: [18F]-APN-1607 (Drug)
Cognitively Normal (HV)
Experimental
Cognitively Normal will undergo PET imaging using [18F]-APN-1607
干预措施: [18F]-APN-1607 (Drug)
结局指标
主要结局
Evaluate the consistency between the visual interpretation results of [18F]-APN-1607 injection PET imaging and the authenticity standards.
时间窗: 8 months
Summary of visual reads by 5 blinded readers and concordance analysis between NIA-AA postmortem neuropathology and \[18F\]-APN-1607 PET visual reads.
次要结局
- Evaluation of the safety of [18F]-APN-1607 injection.(8 months)
- Correlation between the results of semi-quantitative PET imaging analysis (SUVR) and brain tissue pathological NFT scores.(8 months)
研究者
研究点 (1)
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