NCT07228078招募中2 期
An Open-Label Extension (OLE) Study to Evaluate the Long-Term Safety, Tolerability and Exploratory Efficacy of SNK01 in Participants With Alzheimer's Disease (Study SNK01-AD02)
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
研究概览
简要总结
Open-Label Extension Protocol to SNK01-AD01 Study
详细描述
Open-label extension study to assess long-term safety and tolerability of SNK01 administered as an intravenous (IV) infusion every 3 weeks in participants with Alzheimer's Disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be considered eligible for participation in the study if all the following criteria are satisfied:
- •The participant or their legally authorized representative must be willing and able to give their informed consent in writing and comply with the requirements of this study protocol. Informed consent for participants or their legally authorized representative and caregivers will be obtained before any trial-related activity. (Trial-related activities are any procedure that would not be performed during normal treatment of the subject).
- •Participants must have a reliable study partner/caregiver (per investigator judgement for instance a family member, partner etc., guardian (must be always the same person)) who is in close contact with the patient, available on call and who is able to contribute to the assessment of the ratings of the functional endpoints at specific study visits. This person will be able to communicate in the language in which the participant is being assessed and should also serve as a backup contact for the study site.
- •Participants previously completed participation in study SNK01-AD01.
排除标准
- •Participants who fulfill any of the following criteria will not be recruited into the study:
- •Any participant whose safety the investigator considers to be at risk from this trial's intervention.
研究组 & 干预措施
Open-Label
Experimental
SNK01
干预措施: SNK01 (Biological)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
时间窗: 1 Year
Evaluate the safety and tolerability of SNK01 assessed by labs, PE and AEs
次要结局
- Preliminary efficacy in cognitive assessment scores of CDR-SB(1 Year)
- Preliminary efficacy in cognitive assessment scores of MMSE(1 Year)
- Preliminary efficacy in cognitive assessment scores of NPI(1 Year)
- Preliminary efficacy in cognitive assessment scores of ADCS-ADL-Severe(1 Year)
- Preliminary efficacy in cognitive assessment scores of ADAS-Cog(1 Year)
研究者
研究点 (1)
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