A Double-blind, Randomized, Parallel-group Multiple Dose Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Alzinova AB
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Number of participants with clinically significant cognitive or functional worsening of Alzheimer's Disease(AD) according to Alzheimer's DiseaseCooperative Study -Clinician's Global Impression of Change (ADCS-CGIC)scores of 6 and 7
研究概览
简要总结
The main purpose of this study is to evaluate safety, tolerability and immunogenicity of the vaccine ALZ-101 against Alzheimer's Disease. Patients diagnosed with early Alzheimer's will be included. The study have two parts. The Part A (including A1 and A2), includes four doses of ALZ-101 or corresponding placebo given over 16 weeks. Participant will be followed up to Week 30 in Part A1 and either continue in the extension part of the study, Part B, or complete Part A1. Participant not eligible to Part B will be followed up until Week 68 with no further dosing. Participant eligible for Part B will be treated with 2 doses of open-label ALZ-101, over 16 weeks and followed up during in total 68 weeks (Part A1 and B). Part A2 participants will be followed over 20 weeks.
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)
盲法说明
The arm with ALZ-101 400 μg will be open-labelled treatment
入排标准
- 年龄范围
- 50 Years 至 83 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ALZ-101 125 μg
Intramuscular injection of 125 μg of ALZ-101 adjuvanted vaccine dosed once a month at four doses
干预措施: ALZ-101 (Biological)
ALZ-101 250 μg
Intramuscular injection of 250 μg of ALZ-101 adjuvanted vaccine dosed once a month at four doses
干预措施: ALZ-101 (Biological)
Placebo
Intamuscular Saline solution mixed adjuvant and dosed once a month at four doses
干预措施: Placebo (Other)
ALZ-101 400 μg
Intramuscular injection of 400 μg of ALZ-101 adjuvanted vaccine dosed once a month at four doses
干预措施: ALZ-101 (Biological)
结局指标
主要结局
Number of participants with clinically significant cognitive or functional worsening of Alzheimer's Disease(AD) according to Alzheimer's DiseaseCooperative Study -Clinician's Global Impression of Change (ADCS-CGIC)scores of 6 and 7
时间窗: From first dose to study completion, an average 1 year
Any clinically significant worsening of cognitive functions as assessed by Alzheimer's DiseaseCooperative Study -Clinician's Global Impression of Change \[ADCS-CGIC\]scores. Scores are graded from 1 to 7, where 1 means very much improved cognitive function and 7 very much worsening cognitive function.
Number of AEs of special interest (AESIs), including injection-related events (IREs)and amyloid-related imaging abnormalities (ARIAs)
时间窗: From enrolment through study completion, an average 1 year
Any adverse or adverse events of special interest that could be associated with the treatment.
Number of adverse events (AEs) and serious AEs (SAEs)
时间窗: From enrolment through study completion, an average 1 year
Any adverse or serious adverse events that could be associated with the study procedure.
Number of participants with treatment-emergent AEs and SAEs
时间窗: From enrolment through study completion, an average 1 year
Any adverse or serious adverse events that could be associated with the treatment.
次要结局
- Number of titre-based responders(From first dose to study completion, an average 1 year)
- Aβ-specific antibody titre(From first dose to study completion, an average 1 year)
- Area under serum Aβ-specific antibody titre curve (AUC)(From first dose to week 20)