2022-501188-42-00招募中2 期
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study with a Long-Term Extension Treatment Period to Assess the Efficacy and Safety of JNJ-63733657, an Anti-tau Monoclonal Antibody, in Participants with Early Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 195
- 试验地点
- 30
- 主要终点
- Change from baseline on the iADRS total score at week 104
研究概览
简要总结
The primary objective is to evaluate the effect of JNJ-63733657 versus placebo on clinical decline as measured by the iADRS, a composite of cognition and function
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •55 to 80 years of age, inclusive, at the time of initial consent.
- •Early AD: Gradual and progressive subjective decline in the participant's cognition over at least the past 6 months, as reported by the participant and informant (study partner) and CDR-GS of 0.5 and memory box score ≥0.5 at screening.
- •Evidence of pathologic tau on a screening tau PET scan reviewed centrally by a qualified reader, as prespecified in a separate Imaging Charter.
- •Have a designated study partner who has adequate literacy to participate and be judged to have high likelihood of completing the study with the participant
- •For other inclusion criteria, please refer to the protocol
排除标准
- •Participants with CDR-GS ≥2 at predose baseline CDR administration.
- •Participants who fulfill diagnostic criteria for MCI or dementia/mild or major neurocognitive disorder suspected to be due to any etiology other than AD (eg, MCI/dementia due to frontotemporal lobar degeneration, diffuse Lewy body disease, Parkinson's disease, cerebrovascular disease, normal pressure hydrocephalus, head injury, drug or alcohol abuse/dependence, anoxic brain injury, etc).
- •GDS-30 score >
- •Known carriers of a Presenilin 1 (PSEN1), PSEN2, or Amyloid Precursor Protein mutation associated with Autosomal Dominant AD or any other neurodegenerative disease.
- •For other exclusion criteria, please refer to the protocol
结局指标
主要结局
Change from baseline on the iADRS total score at week 104
Change from baseline on the iADRS total score at week 104
次要结局
未报告次要终点
研究者
CTIS Point of Contact
Scientific
Janssen - Cilag International
研究点 (30)
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