NCT05310071终止3 期
A Phase 3b/4 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Verify the Clinical Benefit of Aducanumab (BIIB037) in Participants With Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Biogen
- 入组人数
- 1,512
- 试验地点
- 262
- 主要终点
- Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score at Week 78
研究概览
简要总结
The primary objective of this study is to verify the clinical benefit of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score as compared with placebo in participants with early Alzheimer's disease.
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
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant must have confirmed amyloid beta pathology by cerebrospinal fluid (CSF) or amyloid PET
- •Must have a history of subjective memory decline with gradual onset and slow progression over the 6 months before Screening, confirmed by study partner
- •The participant must have 1 informant/care partner who, in the Investigator's opinion, has frequent and sufficient contact with the participant (at least 10 hours/week in person or by phone) as to be able to provide accurate information about the participant's cognitive and functional abilities over time
- •Must meet all of the following clinical criteria for MCI due to Alzheimer's disease or mild Alzheimer's disease according to National Institute on Aging and Alzheimer's Association (NIA-AA) criteria
- •Have an MMSE score between 22 and 30 inclusive
- •Have a CDR memory score >0.5
- •Have a Clinical Dementia Rating Scale Global Score (CDR-GS) of 0.5 or 1.0
- •Have a Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score of 85 or lower indicative of objective cognitive impairment
- •Apart from a clinical diagnosis of early Alzheimer's disease, the participant must be in good health as determined by the Investigator based on medical history and screening assessments
- •Must consent to apolipoprotein E (ApoE) genotyping. (Note: Participants are not required to be ApoE ε4 carriers)
排除标准
- •Any uncontrolled medical or neurological/neurodegenerative condition (other than Alzheimer's disease) that, in the opinion of the Investigator, might be a contributing cause of the participant's cognitive impairment
- •Clinically significant and/or unstable psychiatric illness within 6 months prior to Screening
- •Transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year prior to Screening
- •History of severe allergic or anaphylactic reactions or of hypersensitivity to any of the inactive ingredients in the drug product
- •Participation in any study with purported disease-modifying effect in Alzheimer's disease within 12 months prior to Screening unless documentation of receipt of placebo is available
- •Current use or previous use of medications with a purported disease-modifying effect in Alzheimer's disease, outside of investigational studies
- •Use of any medications that, in the opinion of the Investigator, may contribute to cognitive impairment, put the participant at higher risk for AEs, or impair the participant's ability to perform cognitive testing or complete study procedures
- •Use of any investigational drug
- •Prior exposure to aducanumab either commercially or by participation in a previous study with aducanumab. (Participants are eligible if they did not receive active aducanumab.)
- •A negative PET scan result with any amyloid-targeting ligand within 12 months prior to Screening
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Aducanumab
Experimental
Participants will receive aducanumab, up to 10 milligrams per kilogram (mg/kg), monthly (once every four weeks), administered as intravenous (IV) infusion.
干预措施: Aducanumab (Drug)
Placebo
Placebo Comparator
Participants will receive placebo, monthly (once every four weeks), administered as IV infusion.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score at Week 78
时间窗: Baseline, Week 78
The Clinical Dementia Rate Scale integrates assessments from 3 domains of cognition (memory, orientation, judgment/problem-solving) and 3 domains of function (community affairs, home/hobbies, personal care). Following the caregiver interview and systematic participant examination, the rater assigns a score describing the participant's current performance level in each of these domains of life functioning. The "Sum of boxes" scoring methodology sums the score for each of the 6 domains and provides a value ranging from 0 to 18. Higher scores indicate greater impairment. A positive change from baseline indicates greater impairment.
次要结局
- Change From Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Score at Weeks 78 and 106(Baseline, Weeks 78 and 106)
- Change From Baseline in Alzheimer's Disease Cooperative Study for Activities of Daily Living in Mild Cognitive Impairment (ADCS-ADL-MCI) Scale Score at Weeks 78 and 106(Baseline, Weeks 78 and 106)
- Change From Baseline in Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog13) at Weeks 78 and 106(Baseline, Weeks 78 and 106)
- Change From Baseline in Mini-Mental State Examination (MMSE) Scale Score at Weeks 78 and 106(Baseline, Weeks 78 and 106)
- Change From Baseline in Neuropsychiatric Inventory-10 (NPI-10) Score at Weeks 78 and 106(Baseline, Weeks 78 and 106)
- Change From Baseline in Amyloid Positron Emission Tomography (PET) Signal at Weeks 78 and 104(Baseline, Weeks 78 and 104)
- Change From Baseline in Tau PET Signal at Weeks 78 and 104(Baseline, Weeks 78 and 104)
- Change From Baseline in CDR-SB Score at Week 106(Baseline, Week 106)
- Change From Baseline in Global Statistical Test (GST) Composite Z-Score at Weeks 78 and 106(Baseline, Weeks 78 and 106)
研究者
研究点 (262)
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