Interventional, Open-label, Multiple-immunisation Study of the Immunogenicity, Pharmacodynamics and Safety of Lu AF20513 in Patients With Mild Alzheimer's Disease or Mild Cognitive Impairment Due to Alzheimer's Disease
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 3
- 主要终点
- AUC
研究概览
简要总结
The purpose of this study is to study the effect of monthly dosing with a single dose of Lu AF20513, with and without booster vaccine, on antibody response.
详细描述
Cohort 1 encompasses 8 patients enrolled prior to the Protocol Amendment (PA) 1, dose regimen 1.
Cohort 2 includes patients enrolled under the PA and will consist of 20 patients, randomly assigned to two arms:
- dose regimen 2: 10 patients who will receive one administration of booster vaccine 4 weeks prior to the first IMP administration
- dose regimen 3: 10 patients who will not receive a booster vaccine
After the PA1, the study consists of the following periods:
- Screening Period - up to 12 weeks
- Priming period: 28 weeks, monthly dosing with Lu AF20513
- Maintenance Period - 56 weeks, quarterly dosing with Lu AF20513
- Follow-up Period - 4 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has a diagnosis of AD or Mild Cognitive Impairment (MCI) due to AD.
- •The patient has evidence of an abnormal amyloid and tau status, consistent with AD, by means of a positive CSF test at screening
- •The patient is aged ≥50 and ≤85 years. If a woman, the patient must be post-menopausal.
排除标准
- •The patient has participated in a clinical study where he/she has received passive or active anti-Aβ immunotherapy or other active immunisation for the treatment of AD.
- •The patient has, in the investigator's opinion, evidence and/or history (clinically or on MRI) of any clinically significant neurodegenerative disease, serious neurological disorder, other intracranial or systemic diseases or conditions resulting in a definite or probable diagnosis of Major or Mild Neuro-Cognitive disorder other than AD, per DSM-5® criteria.
- •Other in- and exclusion criteria may apply
研究组 & 干预措施
Cohort 1 - dose regimen 1
Cohort 1: encompasses patients enrolled prior to the PA1
干预措施: Lu AF20513 (Drug)
Cohort 2 - dose regimen 2
Cohort 2: 10 patients who will receive one administration of booster vaccine prior to the first IMP administration
干预措施: Lu AF20513 (Drug)
Cohort 2 - dose regimen 2
Cohort 2: 10 patients who will receive one administration of booster vaccine prior to the first IMP administration
干预措施: booster vaccine (Biological)
Cohort 2 - dose regimen 3
Cohort 2: 10 patients who will not receive a booster vaccine
干预措施: Lu AF20513 (Drug)
结局指标
主要结局
AUC
时间窗: From Week 0 to Week 28
Area under antibody titre curve (AUC) induced upon treatment with Lu AF20513
Cmax
时间窗: From Week 0 to Week 28
maximum antibody titre (Cmax) induced upon treatment with Lu AF20513
Titre response
时间窗: From Week 0 to Week 28
Any patients with antibody titre above the patient's baseline titre in either of the applied assays for antibody assessment
次要结局
- Amyloid load(From baseline to week 84)