ISRCTN78730935进行中（未招募）2 期
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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 498
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. 55 to 75 years of age, inclusive, at randomisation visit.
- •2. Elevated brain tau pathology defined as Braak 3 ROI SUVR > 1.1 on a screening tau PET scan, reviewed centrally by a qualified reader.
- •3. CDR global score of 0 at screening and baseline.
- •4. MMSE =27 (with educational adjustment).
- •5. Able to read and write and with a minimum 5 years of formal education as reported by participant and study partner at screening.
排除标准
- •1. MRI evidence of any brain disease or intracranial pathology other than potential very early signs of AD or typical age-related changes, which in the opinion of the investigator or the central imaging reader and/or the sponsor, may affect cognition.
- •2. History consistent with or known autosomal dominant AD.
- •3. 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.
- •4. Diagnosis ofMild Cognitive Impairment (MCI)
- •5. Presence of any neurological, psychiatric, or medical conditions associated with a longterm risk of significant cognitive impairment or dementia
研究者
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