jRCT2031240382招募中不适用
A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study, to Assess Efficacy, Safety and Immunogenicity of JNJ-64042056, a Phosphorylated Tau Targeted Active Immunotherapy, in Participants with Preclinical Alzheimer's Disease (ReTain)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 498
- 主要终点
- Change From Baseline in Preclinical Alzheimer's Disease, Cognitive Composite 5 (PACC-5) Total Scores up to Week 206
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 55age old over 至 75age old under（—）
- 性别
- All
入选标准
- •Elevated brain tau pathology defined as Braak 3 region of interest standardized uptake value ratio (ROI SUVR) greater than (>) 1.1 on a screening tau PET scan, reviewed centrally by a qualified reader
- •Clinical Dementia Rating (CDR) global score of 0 at screening and baseline
- •Mini Mental State Examination (MMSE) greater than or equal to (>=) 27 (with educational adjustment)
- •Able to read and write and with a minimum 5 years of formal education as reported by participant and study partner at screening
- •A participant must be of non-childbearing potential
排除标准
- •History consistent with or known autosomal dominant AD (mutation identified in the family and/or participant)
- •Fulfills diagnostic criteria for Alzheimer's Dementia or non-Alzheimer's Dementia, including, but not limited to Frontotemporal Dementia (FTD), Diffuse Lewy Body Dementia (DLBD), Vascular Dementia (VAD), alcoholic dementia, Parkinson's dementia, Korsakov, Creutzfeldt-Jakob or other prion diseases, Posterior Cortical Atrophy
- •Diagnosis of Mild Cognitive Impairment (MCI)
- •Vitamin B12 or folate levels below the central laboratory lower limit of normal, unless in the opinion of the investigator it does not require treatment
- •History of or current neurological disease other than preclinical AD that may make interpretation of possible new neurological signs or symptoms difficult
结局指标
主要结局
Change From Baseline in Preclinical Alzheimer's Disease, Cognitive Composite 5 (PACC-5) Total Scores up to Week 206
时间窗: Baseline up to Week 206
Cognition will be measured using the PACC-5 scale, which includes 5 components: free/cued selective reminding test, delayed paragraph recall (logical memory test), digit-symbol substitution test, mini mental state examination, and the category fluency test (CFT). PACC-5 is a composite score which provides unique information about early cognitive decline not currently captured by the episodic memory, executive function, and global cognition components. The score reflects an averaged z-score, with higher scores indicating better cognitive performance.
次要结局
未报告次要终点
研究者
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