NCT07169578进行中（未招募）3 期
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease (MCI to Mild Dementia Due to AD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,101
- 试验地点
- 321
- 主要终点
- Change From Baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of trontinemab in participants with early symptomatic Alzheimer's disease (AD) (mild cognitive impairment [MCI] to mild dementia due to AD).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness and ability to complete all aspects of the study (including MRI, clinical genotyping, and PET imaging or CSF as applicable) for the duration of the study. The participant should be capable of completing assessments either alone or with the help of the study partner
- •Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted)
- •Evidence of AD pathological process, as confirmed on amyloid PET scan. A CSF tau181/Aβ42 ratio may be used as an alternative option if amyloid PET is not available
- •Probable AD dementia or MCI due to AD, also known as an Alzheimer's clinical syndrome clinical Stage 3 or Stage 4
- •Screening MMSE score ≥ 22 and CDR-GS of 0.5 or 1.0
- •Participant- and/or Informant-reported history of cognitive decline with gradual onset and progression over the last 1 year before screening
- •A Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index (RBANS DMI) score of 85 or order
- •Availability of a "study partner" as defined by the protocol
排除标准
- •Any evidence of a condition other than AD that may affect cognition
- •History or presence of clinically significant cerebrovascular disease
- •History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system (CNS) trauma
- •History or presence of clinically significant intracranial mass
- •MRI evidence of significant cerebral abnormalities or inability to tolerate MRI procedures or contraindication to MRI
- •Any other medical conditions (e.g., cardiovascular, hepatic, renal disease) which are not stable and adequately controlled or which in the opinion of the investigator could affect the participant's safety in the study or interfere with the study assessments
- •History of malignancy with the following exceptions: if considered to be cured; malignancies with a negligible risk of metastasis or death
研究组 & 干预措施
Trontinemab
Experimental
Participants will receive intravenous (IV) trontinemab.
干预措施: Trontinemab (Drug)
Placebo
Placebo Comparator
Participants will receive IV placebo.
干预措施: Placebo (Other)
结局指标
主要结局
Change From Baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)
时间窗: Baseline - Week 72
Change from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)
时间窗: Baseline - Week 72
Change from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)
时间窗: Baseline - Week 72
次要结局
- Change From Baseline Through Week 72 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13)(Baseline - Week 72)
- Change From Baseline Through Week 72 in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) Total Score and Instrumental Score(Baseline - Week 72)
- Change From Baseline Through Week 72 in Integrated Alzheimer's Disease Rating Scale (iADRS)(Baseline - Week 72)
- Change From Baseline Through Week 72 in Mini-Mental State Examination (MMSE)(Baseline - Week 72)
- Change From Baseline in CDR-SB(Baseline up to but excluding Week 72)
- Time to Increase in Clinical Dementia Rating, Global Score (CDR-GS)(Baseline - Week 72)
- Percentage of Participants With Adverse Events (AEs)(Baseline - Week 72)
- Change from Baseline in C-SSRS (Columbia-Suicide Severity Rating Scale)(Baseline - Week 72)
- Percentage of Participants With Amyloid-related Imaging Abnormalities (ARIA) Magnetic Resonance Imaging (MRI) Findings(Baseline - Week 72)
- Percentage of Participants With Infusion-related Reactions (IRR)(Baseline - Week 72)
- Percentage of Participants With Anti-drug Antibodies (ADAs) to Trontinemab(Baseline - Week 72)
- Change From Baseline Through Week 72 in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan(Baseline - Week 72)
- Change From Baseline to Week 72 in Brain tau Load as Measured by tau PET Scan in a Subset of Participants(Baseline - Week 72)
- Change From Baseline Through Week 72 in Cerebrospinal Fluid (CSF) Biomarkers of Disease p-tau181, Neurogranin, Amyloid Beta(Aβ)42, Aβ42/40 in a Subset of Participants(Baseline - Week 72)
- Change From Baseline Through Week 72 in Blood Biomarkers p-tau217, Glial Fibrillar Acidic Protein (GFAP), Aβ42, Aβ42/40(Baseline - Week 72)
- Change from baseline through Week 72 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13)(Baseline - Week 72)
- Change from baseline through Week 72 in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) total score and instrumental score(Baseline - Week 72)
- Change from baseline through Week 72 in Integrated Alzheimer's Disease Rating Scale (iADRS)(Baseline - Week 72)
- Change from baseline through Week 72 in Mini-Mental State Examination (MMSE)(Baseline - Week 72)
- Change from baseline in CDR-SB(Baseline up to but excluding Week 72)
- Time to increase in Clinical Dementia Rating, Global Score (CDR-GS)(Baseline - Week 72)
- Percentage of participants with adverse events (AEs)(Baseline - Week 72)
- Percentage of participants with amyloid-related imaging abnormalities (ARIA) magnetic resonance imaging (MRI) findings(Baseline - Week 72)
- Percentage of participants with infusion-related reactions (IRR)(Baseline - Week 72)
- Percentage of participants with anti-drug antibodies (ADAs) to trontinemab(Baseline - Week 72)
- Change from baseline through Week 72 in brain amyloid load as measured by amyloid positron emission tomography (PET) scan(Baseline - Week 72)
- Change from baseline to Week 72 in brain tau load as measured by tau PET scan in a subset of participants(Baseline - Week 72)
- Change from baseline through Week 72 in cerebrospinal fluid (CSF) biomarkers of disease p-tau181, neurogranin, Aβ42 in a subset of participants(Baseline - Week 72)
- Change from baseline through Week 72 in blood biomarkers p-tau217, glial fibrillar acidic protein (GFAP)(Baseline - Week 72)
- Change from baseline through Week 72 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13)(Baseline - Week 72)
- Change from baseline through Week 72 in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) total score and instrumental score(Baseline - Week 72)
- Change from baseline through Week 72 in Integrated Alzheimer's Disease Rating Scale (iADRS)(Baseline - Week 72)
- Change from baseline through Week 72 in Mini-Mental State Examination (MMSE)(Baseline - Week 72)
- Change from baseline in CDR-SB(Baseline up to but excluding Week 72)
- Time to increase in Clinical Dementia Rating, Global Score (CDR-GS)(Baseline - Week 72)
- Percentage of participants with adverse events (AEs)(Baseline - Week 72)
- Percentage of participants with amyloid-related imaging abnormalities (ARIA) magnetic resonance imaging (MRI) findings(Baseline - Week 72)
- Percentage of participants with infusion-related reactions (IRR)(Baseline - Week 72)
- Percentage of participants with anti-drug antibodies (ADAs) to trontinemab(Baseline - Week 72)
- Change from baseline through Week 72 in brain amyloid load as measured by amyloid positron emission tomography (PET) scan(Baseline - Week 72)
- Change from baseline to Week 72 in brain tau load as measured by tau PET scan in a subset of participants(Baseline - Week 72)
- Change from baseline through Week 72 in cerebrospinal fluid (CSF) biomarkers of disease p-tau181, neurogranin, Aβ42 in a subset of participants(Baseline - Week 72)
- Change from baseline through Week 72 in blood biomarkers p-tau217, glial fibrillar acidic protein (GFAP)(Baseline - Week 72)
研究者
研究点 (321)
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