NCT05508789进行中（未招募）3 期
Global Study to Investigate Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease
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
- 1,500
- 试验地点
- 231
- 主要终点
- Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)
研究概览
简要总结
The reason for this study is to assess the safety and efficacy of donanemab in participants with early Alzheimer's disease. The study duration including screening and follow-up is up to 93 weeks.
详细描述
TRAILBLAZER-ALZ 5 is a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of donanemab in participants with early symptomatic AD (prodromal AD and mild dementia due to AD) and the presence of AD pathology.
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
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gradual and progressive change in memory function reported by the participant or informant for ≥6 months.
- •A MMSE score of 20 to 28 (inclusive) at screening visit.
- •Meet amyloid scan (central read) criteria.
- •Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week), and will accompany the participant to the study or be available by telephone at designated times.
- •A second study partner may serve as backup. The study partner(s) is/are required to accompany the participant for signing consent. The study partner must be present on all days the cognitive and functional scales are administered.
- •If a participant has a second study partner, it is preferred that 1 study partner be primarily responsible for the CDR and the ADCS-ADL assessments.
- •Days requiring the following assessments and scales must have a study partner available by telephone if not accompanying participant for the following assessments
- •AEs and concomitant medications
- •Stable concomitant symptomatic AD medications and other medications that may impact cognition for at least approximately 30 days prior to randomization.
排除标准
- •Has significant neurological disease affecting the central nervous system other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures (except febrile childhood seizures).
- •Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study; or has a life expectancy of <24 months.
- •History of cancer within the last 5 years, except of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, nonprogressive prostate cancer, or other cancers with low risk of recurrence or spread.
- •Contraindication to MRI or PET scans.
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will receive placebo IV
干预措施: Placebo (Drug)
Donanemab
Experimental
Participants will receive donanemab intravenously (IV)
干预措施: Donanemab (Drug)
结局指标
主要结局
Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)
时间窗: Baseline, Week 76
Change from Baseline on the iADRS in at least one of the low-medium tau pathology population or no-very low and low-medium tau pathology population.
次要结局
- Change from Baseline on the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL) Score(Baseline, Week 76)
- Change from Baseline on the Mini Mental State Examination (MMSE) Score(Baseline, Week 76)
- Change from Baseline in Amyloid Plaque Deposition as by Amyloid Positron Emission Tomography (PET) Scan(Baseline, Week 76)
- Pharmacokinetics (PK): Trough Serum Concentration of Donanemab(Baseline to Week 76)
- Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADAs)(Week 76)
- Change from Baseline on the iADRS(Baseline, Week 76)
- Change from Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)(Baseline, Week 76)
- Change from Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score(Baseline, Week 76)
研究者
研究点 (231)
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