Alzheimer's Tau Platform (ATP): Regimen Specific Appendix for AADvac1
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 450
- 试验地点
- 3
- 主要终点
- Reduction of brain tau deposition as measured by tau positron emission tomography (PET)
研究概览
简要总结
The Alzheimer's Tau Platform (ATP) is a multi-center platform trial to evaluate the safety and effectiveness of tau-directed therapies, alone or in combination with donanemab, in adults aged 50-80 with late preclinical or early prodromal Alzheimer's disease.
Regimen A will evaluate the safety and efficacy of AADvac1, alone or in combination with donanemab.
详细描述
The Alzheimer's Tau Platform (ATP) is a multi-center platform trial to evaluate the safety and effectiveness of tau-directed therapies, alone or in combination with donanemab, in adults aged 50-80 with late preclinical or early prodromal Alzheimer's disease. This platform trial allows for the simultaneous testing of multiple tau therapies under a shared master protocol. This means that multiple investigational products will be tested simultaneously or sequentially. Each investigational product will be tested in a regimen. The ATP Master Protocol is registered as NCT06957418.
Once a participant enrolls into the Master Protocol and meets all eligibility criteria, the participant will be eligible to be randomized into a currently enrolling regimen. All participants will have an equal chance of being randomized to any currently enrolling regimen.
Participants randomized to Regimen A - AADvac1 will be randomized in a 1:1:1 ratio to either AADvac1 alone, combination AADvac1 therapy with donanemab, or donanemab alone (active control). The allocation ratio may be change based on the number of concurrent active regimens to ensure appropriate number of individuals randomized to the control arm across all active regimes.
Regimen A will enroll by invitation, as participants may not choose to enroll in a given regimen. Participants must first enroll into the Master Protocol and be eligible to participate in the Master Protocol before being able to be randomly assigned to Regimen A.
For a list of enrolling sites, please see the ATP Master Protocol under NCT06957418.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT06957418).
排除标准
- •No additional exclusion criteria beyond the exclusion criteria specified in the Master Protocol (NCT06957418).
研究组 & 干预措施
Combination AADvac1 therapy with donanemab
Intravenous infusions of donanemab for 6 months, combination donanemab and subcutaneous injections of AADvac1 for 6 months, followed by 18 months of AADvac1 injections alone (n = 150)
干预措施: AADvac1 (Drug)
AADvac1 monotherapy
Intravenous infusions of donanemab for 6 months, followed by subcutaneous injections of AADvac1 over 24 months (n = 150)
干预措施: AADvac1 (Drug)
Combination AADvac1 therapy with donanemab
Intravenous infusions of donanemab for 6 months, combination donanemab and subcutaneous injections of AADvac1 for 6 months, followed by 18 months of AADvac1 injections alone (n = 150)
干预措施: Donanemab (Drug)
Donanemab active control
Intravenous infusions of donanemab for 6 months, combination donanemab and AADvac1-matched placebo subcutaneous injections for 6 months, followed by 18 months of AADvac1-matched placebo injections alone (n = 150).
干预措施: Donanemab (Drug)
结局指标
主要结局
Reduction of brain tau deposition as measured by tau positron emission tomography (PET)
时间窗: 0, 6, 18 and 30 months
To determine whether at least one tau therapy, either alone or in combination with donanemab, will produce a greater reduction in brain tau deposition as measured by 18F-MK-6240 PET compared to donanemab alone.
Reduction of brain tau deposition as measured by tau positron emission tomography (PET)
时间窗: 0, 6, 18 and 30 months
To determine whether at least one tau therapy, either alone or in combination with an anti-amyloid mAb, will produce a greater reduction in brain tau deposition as measured by 18F-MK-6240 PET compared to anti-amyloid mAb alone.
次要结局
- Disease progression as measured by plasma biomarkers(30 months)
- Disease progression as measured by plasma biomarkers(30 months)
研究者
Paul S. Aisen
Director, ATRI
University of Southern California