NCT06544616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
Janssen Pharmaceutica N.V., Belgium91 个研究点 分布在 6 个国家目标入组 55 人开始时间: 2024年7月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 55
- 试验地点
- 91
- 主要终点
- Change From Baseline in Brain Tau Burden as Measured by Tau PET in Specified Regions of Interest (ROI)
研究概览
简要总结
The purpose of this study is to assess whether JNJ-64042056 affects the spread and build up of tau (a protein in brain) when compared with placebo, using brain scan (tau PET) to determine results from specific areas of the brain.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 (or equivalent based on emerging data) on a screening tau PET scan, reviewed centrally by a qualified reader to enrich for probability of disease progression during the study
- •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) at screening
- •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 the investigator determines that supplementation is not required after randomization
- •History of or current neurological disease other than preclinical AD that may make interpretation of possible new neurological signs or symptoms difficult
研究组 & 干预措施
Arm B: Placebo
Placebo Comparator
Participants will receive IM injection of placebo from Week 0 up to a maximum of Week 76.
干预措施: Placebo (Drug)
Arm A: JNJ-64042056
Experimental
Participants will receive intramuscular (IM) injection of JNJ-64042056 from Week 0 up to a maximum of Week 76.
干预措施: JNJ-64042056 (Drug)
结局指标
主要结局
Change From Baseline in Brain Tau Burden as Measured by Tau PET in Specified Regions of Interest (ROI)
时间窗: Baseline up to Week 102
Change from baseline in brain tau burden, as measured by tau PET (including but not limited to Braak I-VI ROIs, tau naive composite ROI, Connection Rank ROI, and New Tau Composite ROI Volume) will be reported.
次要结局
- Number of Participants with Clinical Laboratory Abnormalities(Up to Week 102)
- Levels of IgG Titers Against Enriched Paired Helical Filaments (ePHF), p-tau and tau in Serum(Up to Week 102)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(Up to Week 104)
- Number of Participants With Reactogenicity(Up to Week 78)
- Number of Participants with Vital Signs Abnormalities(Up to Week 102)
- Change from Baseline in Electrocardiogram (ECG) Values(Baseline up to Week 102)
- Change From Baseline in Columbia-Suicidality Severity Rating Scale (C-SSRS)(Baseline up to Week 102)
- Change From Baseline in Magnetic Resonance Imaging (MRI) Findings(Baseline up to Week 102)
- Change From Baseline in Columbia-Suicidality Severity Rating Scale (C-SSRS)(Baseline up to Week 206)
- Change From Baseline in Magnetic Resonance Imaging (MRI) Findings(Baseline up to Week 206)
- Change From Baseline in Brain tau Burden as Measured by tau PET(Baseline and Weeks 102, 154 and 206)
- Change From Baseline in PACC-5 Individual Domain Scores(Baseline up to Week 206)
- Time to Event of Clinical Progression as Measured by Clinical Dementia Rating-Global Score (CDR-GS)(Baseline up to Week 206)
- Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Scores(Baseline up to Week 206)
- Change from Baseline in Tau PET Standardized Uptake Value Ratio (SUVR) Biomarkers(Baseline up to Week 206)
- Change From Baseline in p217+tau(Baseline up to Week 206)
- Change From Baseline in PACC-5 Total Score(Baseline up to Week 180)
- Change From Baseline in Brain Tau Burden as Measured by Tau PET in Other ROI(Baseline up to Week 206)
- Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living -Prevention Instrument (ADCS-ADL-PI)(Baseline up to Week 206)
- Change From Baseline in Mild Behavioral Impairment Checklist (MBI-C) Score(Baseline up to Week 206)
- Change From Baseline in European Quality of Life-5 Dimensions 5-Levels (EQ-5D-5L) Score(Baseline up to Week 206)
- Levels of IgG Titers Against Enriched Paired Helical Filaments (ePHF), p-tau and tau in Serum(Up to Week 206)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(Up to Week 208)
- Number of Participants With Reactogenicity(Up to Week 182)
- Change from Baseline in Vital Signs(Baseline up to Week 180)
- Change From Baseline in Clinical Laboratory Values(Baseline up to Week 206)
研究者
研究点 (91)
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相关资讯
AC Immune's Tau-Targeting Immunotherapy Achieves 94-100% Response Rate in Alzheimer's Phase 1b/2a Trial- AC Immune's ACI-35.030 demonstrated exceptional immunogenicity with 94-100% response rates in high-dose cohorts through week 74 in early Alzheimer's disease patients.
- The SupraAntigen®-based therapy required only one injection to induce anti-pTau antibody responses in all participants, showing superior performance over the comparator JACI-35.054.
- ACI-35.030 specifically targeted pathological tau species while sparing normal tau, with significant plasma biomarker changes (p<0.05) compared to placebo.
- Based on these results, ACI-35.030 has advanced to a potentially registration-enabling Phase 2b trial in 500 preclinical Alzheimer's disease participants.last yearJ&J's Alzheimer's Therapies, Posdinemab and JNJ-2056, Receive FDA Fast Track Designation- Johnson & Johnson's posdinemab, a monoclonal antibody targeting phosphorylated tau, has received FDA Fast Track designation for early Alzheimer's treatment.
- JNJ-2056, an anti-tau active immunotherapy, also received Fast Track status, marking the second such designation for J&J's Alzheimer's portfolio in 2024.
- Both therapies are currently in Phase 2b trials, with posdinemab in the "AuTonomy" study and JNJ-2056 in the "ReTain" trial, aimed at slowing disease progression.
- The FDA's Fast Track designation is designed to expedite the review of drugs addressing serious conditions with unmet medical needs, potentially accelerating patient access.last year