NCT07589595招募中2 期
A Phase 2 Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Donanemab in Participants With Early Cognitive Decline, at Least One Core Clinical Feature of Dementia With Lewy Bodies, and Confirmation of Alpha-Synuclein and Amyloid Co-pathology
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 90
- 主要终点
- Change from Baseline on Clinical Dementia Rating - Sum of Boxes (CDR-SB)
研究概览
简要总结
The main purpose of this study is to evaluate whether treatment with donanemab slows the progression of cognitive (how we think, learn, remember, pay attention, and make decisions) and functional (how we are able to perform daily activities) decline. For each participant, the study will last one and a half years.
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
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have gradual and progressive cognitive decline for greater than or equal to ( ≥) 6 months.
- •Have least 1 core clinical feature of dementia with Lewy bodies (DLB).
- •Have a score ≥20 on Montreal Cognitive Assessment (MoCA).
- •Meet plasma P-tau217 criteria.
- •Have a cerebrospinal fluid (CSF) result consistent with the presence of brain amyloid pathology.
- •Have a CSF result consistent with the presence of alpha-synuclein pathology.
- •Have at least 1 reliable study partner who will provide written informed consent to participate, is in frequent contact with the participant, and is familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.
排除标准
- •Have a disease or condition that could interfere with this study or is a current serious or unstable illness.
- •Have, or is suspected to have, a significant neurological disease (other than the studied condition) that affects the central nervous system and may affect the individual's cognition or ability to complete the study.
- •Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence and preventing the completion of the study.
- •Have clinically significant multiple or severe drug allergies, significant atopy, or severe posttreatment hypersensitivity reactions.
- •Have previously received amyloid-targeting therapy.
- •Active immunization against amyloid-beta.
- •Have a centrally read MRI that does not meet study entry criteria.
- •Have contraindication to MRI or PET scans.
- •Have any contraindication to lumbar puncture.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo administered IV
干预措施: Placebo (Drug)
Donanemab (LY3002813)
Experimental
Donanemab (LY3002813) administered as an intravenous (IV) infusion
干预措施: Donanemab (Drug)
结局指标
主要结局
Change from Baseline on Clinical Dementia Rating - Sum of Boxes (CDR-SB)
时间窗: Baseline through Week 52
次要结局
- Change from Baseline for Alzheimer's Disease Assessment Scale - Cognitive Subscale, 13 items (ADAS-Cog13)(Baseline through Week 52)
- Change from Baseline for Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living Inventory (ADCS-iADL)(Baseline through Week 52)
- Time to Clinical Progression of Dementia as Measured by Clinical Dementia Rating - Global Score (CDR-GS)(Baseline through Week 52)
- Change from Baseline in Brain Amyloid Plaque Levels(Baseline through Week 52)
- Trough Concentration at Steady State(Baseline through Week 52)
- Maximum Concentration at Steady State(Baseline through Week 52)
- Antidrug Antibodies (ADA) Against Donanemab(Baseline through Week 52)
- Frequency of Neutralizing Antibodies to Donanemab Treatment-Emergent ADA-Positive Participants(Baseline through Week 52)
- Change from Baseline for Integrated Alzheimer's Disease Rating Scale (iADRS)(Baseline through Week 52)
研究者
研究点 (90)
Loading locations...
相似试验
招募中
2 期
A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease2023-507303-55-00Eli Lilly & Co.224
招募中
3 期
A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer (PACIFIC 8)2023-506891-28-00Astrazeneca AB280
已完成
3 期
A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer’s Disease (TRAILBLAZER-ALZ 6)Dementia2022-502268-18-00Eli Lilly & Co.56
招募中
3 期
Donanemab (LY3002813) Trial in Chinese Participants With Cognitively Unimpaired (Preclinical) Alzheimer's DiseaseAlzheimer DiseaseNCT07571161Eli Lilly and Company140
招募中
2 期
Immunoprevention for High-risk Lung LesionsNCT07284485Robert Samstein59