Assessment of Safety, Tolerability, and Efficacy Measured by Amyloid Reduction of LY3372993 in Early Symptomatic Alzheimer's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,667
- 试验地点
- 150
- 主要终点
- Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo
研究概览
简要总结
The reason for this study is to collect safety and efficacy information regarding the study drug remternetug in participants with early symptomatic Alzheimer's disease (AD).
详细描述
TRAILRUNNER-ALZ 1 is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of remternetug in participants with early symptomatic AD. Initially, 600 participants will enroll in the double-blind treatment period. Participants in the double-blind treatment period will receive remternetug or placebo administered via subcutaneous injection or intravenous infusion.
Following the 52-week main study period, participants will continue participation for up to an additional 76 weeks in an extension period. Participants who previously received remternetug will receive placebo and participants who previously received placebo will receive remternetug. Thus, all participants will receive remternetug if they complete the study.
An additional 974 participants with early Alzheimer's disease will be enrolled to an addendum safety cohort. The participants will be administered open label remternetug via subcutaneous injection or intravenous infusion. Participants enrolled into the addendum safety cohort are not eligible for the extension period.
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)
盲法说明
The main treatment period is double-blinded and the addendum is open-label.
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 cognitive function ≥6 months prior to screening.
- •A Mini-Mental (MMSE) score of 20 to 30 (inclusive) at screening.
- •Has an amyloid PET scan result consistent with the eligibility criteria.
- •Have a reliable study partner who will provide written informed consent to participate and is in frequent contact with the participant.
- •Have adequate literacy, vision, and hearing for the neuropsychological testing in the opinion of the investigator at the time of screening.
- •Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
- •Males and females will be eligible for this study.
- •Women not of childbearing potential (WNOCBP) may participate in this trial.
排除标准
- •Current serious or unstable illnesses 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 with high risk of recurrence and preventing completion of the trial.
- •Participants with any current primary psychiatric diagnosis other than AD that in the investigator's opinion, is likely to confound interpretation of the drug effect, affect cognitive assessment, or affect the participant's ability to complete the study.
- •History of clinically significant multiple or severe drug allergies.
- •Have any clinically important abnormality at screening, as determined by investigator that could be detrimental to the participant, could compromise the study, or show evidence of other etiologies for dementia.
- •Screening magnetic resonance imaging (MRI) which shows evidence of significant abnormality that would suggest another potential etiology for progressive dementia or a clinically significant finding that may impact the participant's ability to safely participate in the study.
- •Have any contraindications for MRI or positron emission tomography (PET).
- •Have had prior treatment with a passive anti-amyloid immunotherapy.
- •Have received active immunization against Aβ in any other study.
- •Have known allergies to remternetug related compounds, or any components of the formulation.
研究组 & 干预措施
Remternetug (IV)
Participants will receive remternetug intravenously (IV)
Participants will receive remternetug IV during the treatment period, then switch to placebo IV in the extension period.
干预措施: Remternetug (IV) (Drug)
Remternetug (SC)
Participants will receive one of two dosing regimens of remternetug subcutaneously (SC)
Participants will receive remternetug SC during the treatment period, then switch to placebo SC in the extension period.
干预措施: Remternetug (SC) (Drug)
Placebo
Participants will receive placebo matching remternetug IV or SC.
Participants will receive placebo IV during the treatment period, then switch to remternetug IV in the extension period.
Participants will receive placebo SC during the treatment period, then switch to LY3372993 SC in the extension period.
干预措施: Placebo (Drug)
Open-Label Addenda Remternetug (IV)
Participants will receive one of six dosing regimens of remternetug IV during the open-label addenda.
干预措施: Remternetug (IV) (Drug)
Open-Label Addenda Remternetug (SC)
Participants will receive one of nine dosing regimens of remternetug SC during the open-label addenda.
干预措施: Remternetug (SC) (Drug)
结局指标
主要结局
Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo
时间窗: Week 52
次要结局
- Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo(Week 24)
- Mean Absolute Change from Baseline in Brain Amyloid Plaque on Amyloid PET Scan for Remternetug versus Placebo(Baseline, Week 24)
- Pharmacokinetics (PK) Observed Trough Serum Concentration (Cmin) of Remternetug(Baseline to Week 52)
- Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADAs)(Baseline to Week 52)
- Time to Reach Complete Amyloid Plaque Clearance on Remternetug versus Placebo(Up to Week 52)