jRCT2031220635进行中（未招募）不适用
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of BIIB080 in Subjects with Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease Dementia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 735
- 主要终点
- -
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
- 50age old over 至 80age old under（—）
- 性别
- All
入选标准
- •Must meet all the clinical staging criteria for MCI due to AD (Stage 3) or mild AD dementia (Stage 4) according to the NIA-AA and must have the following at Screening Visit 1:
- •RBANS Delayed Memory Index score of <= 85, indicative of objective evidence of memory impairment.
- •CDR global score of 0.5 for MCI due to AD or 0.5 or 1 for mild AD dementia.
- •MMSE score of 22 to 30 (inclusive).
- •CDR Memory Box score of >= 0.
- •Evidence of amyloid pathology as measured by PET or CSF sampling.
排除标准
- •Known allergy to BIIB080 or a history of hypersensitivity to any of the inactive ingredients in the drug product .
- •Previous participation in this study or previous studies with BIIB
- •Use of non-disease-modifying AD medications (including but not limited to donepezil, rivastigmine, galantamine, and memantine) at doses that have not been stable for at least 8 weeks prior to Screening Visit 1 and during the screening period up to Study Day
- •Prior participation in any active or passive immunotherapy study targeting amyloid beta, unless documentation of receipt of placebo is available.
- •Prior participation in any passive immunotherapy study targeting tau, unless the last administration occurred 6 months or 5 half-lives, whichever is sooner, prior to Screening or documentation of receipt of placebo is available.
- •Participation in any study involving an investigational treatment targeting tau that is not an immunotherapy, unless documentation of receipt of placebo is available.
- •Participation in a study of any other agent(s) [including gene therapy] not included in exclusion criteria 4, 5, and 6 with a purported disease-modifying effect in AD, unless documentation of receipt of placebo is available.
- •Current use or previous use of medications with a purported disease-modifying effect in AD, outside of investigational studies.
- •Any vaccination given within 10 days prior to Day -
- •COVID-19 vaccinations using RNA or DNA technology are allowed during the study, as well as other types of immunization/vaccination/booster, except during the 10 days before and after clinic visits.
- •Contraindications to having a brain MRI (e.g., MRI-incompatible pacemaker; MRI incompatible aneurysm clips, artificial heart valves, or other metal foreign body; claustrophobia that cannot be medically managed). If the MRI compatibility of implanted devices is unknown, the participant must be excluded from the study.
- •Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 52 weeks prior to the Baseline Visit.
结局指标
主要结局
-
Dose-response in change from Baseline to Week 76 on the CDR-SB
次要结局
- ADCOMS(Week 76)
- CDR-SB(Week 76)
- ADCS-ADL-MCI(Week 76)
- ADAS-Cog 13(Week 76)
- MMSE(Week 76)
- Modified iADRS(Week 76)
研究者
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