A Study of Remternetug Versus Placebo in Early Alzheimer's Disease Participants at Risk for Cognitive and Functional Decline
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,400
- 试验地点
- 259
- 主要终点
- Time to Clinically Meaningful Progression as Measured by Clinical Dementia Rate Scale (CDR)
研究概览
简要总结
The purpose of this study is to measure the difference in time to developing or worsening memory, thinking, or functional problems due to Alzheimer's disease occurring in participants receiving study drug compared to placebo.
Participation could last up to 255 weeks including screening, a double-blind treatment period, and a double-blind observation period. In addition, eligible participants who receive placebo during the double-blind treatment period may choose to extend their study participation to receive open-label remternetug in an 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)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a phosphorylated tau (P-tau) result consistent with the presence of amyloid pathology.
- •Have a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.
- •Have adequate literacy, vision, and hearing for neuropsychological testing at screening.
- •Have a Mini Mental Status Exam (MMSE) score consistent with no to minimal cognitive impairment.
- •Have a Functional Activities Questionnaire (FAQ) score consistent with no to minimal functional impairment.
- •If currently receiving medications as symptomatic treatment for AD, dose has been stable for at least 30 days before screening.
排除标准
- •Have dementia or significant other neurological disease that can affect cognition.
- •Have current serious or unstable illnesses that in the investigator's opinion, could interfere with the analyses of the study.
- •Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence.
- •Have a history of clinically significant multiple or severe drug allergies, or hypersensitivity reactions.
- •Have a clinically important laboratory test result or other abnormality as determined by investigator, prior to randomization, that could be detrimental to the participant or could compromise the study.
- •Have any contraindications for magnetic resonance imaging (MRI).
- •Have a centrally read MRI that does not meets study entry criteria.
- •Prior or Current Therapies
- •Have ever had prior treatment with a passive anti-amyloid immunotherapy.
- •Have received active immunization against Aβ in any other study.
研究组 & 干预措施
Remternetug
Remternetug administered subcutaneously (SC).
干预措施: Remternetug (Drug)
Placebo
Placebo administered SC.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Clinically Meaningful Progression as Measured by Clinical Dementia Rate Scale (CDR)
时间窗: Baseline to Time to Event up to Week 255
Time to clinically meaningful progression as measured by CDR. CDR is a clinician-rated scale that provides an overall assessment of the participant's stage and degree of impairment across the continuum of early Alzheimer's Disease (AD).
次要结局
- Change from Baseline in Clinical Dementia Rate Box Score (SB)(Baseline, Week 255)
- Change from Baseline in Montreal Cognitive Assessment (MoCA)(Baseline, Week 255)
- Change from Baseline in the Category Fluency - Language, Executive Function, Semantic Memory(Baseline, Week 255)
- Change from Baseline in the Continuous Paired Associate Learning (CPAL)(Baseline, Week 255)
- Change from Baseline in International Shopping List Test (ISLT) - Verbal Episodic Mem(Baseline, Week 255)
- Change from Baseline in International Daily Symbol Substitution Test-Medicines (iDSSTm) - Complex Attention Memory(Baseline, Week 255)
- Change from Baseline in Cognitive Function Index (CFI)(Baseline, Week 255)
- Change from Baseline in Mild Behavioral Impairment Checklist (MBI-C)(Baseline, Week 255)
- Change from Baseline in Alzheimer's Disease Cooperative Study (ADCS) Activities of Daily Living - Prevention Instrument (ADCS-ADL-PI)(Baseline, Week 255)
- Pharmacokinetics: Serum Concentrations of Remternetug(Baseline through Week 255)
- Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADAs)(Baseline through Week 255)