NCT07838155尚未招募4 期
A Phase 4, Multicenter, Open-Label, Single-Arm Study to Evaluate the Safety and Tolerability of Donanemab in Indian Participants With Early Symptomatic Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 9
- 主要终点
- Number of Participants with Any Occurrence of Amyloid-Related Imaging Abnormalities (ARIA)
研究概览
简要总结
The main purpose of this study is to assess how well Donanemab is tolerated and what side effects may occur in Indian participants with early symptoms of Alzheimer's Disease (AD). For each participant, the study will last up to approximately 84 weeks and will include visits every 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 greater than or equal to (≥) 6 months.
- •Clinical diagnosis of mild cognitive impairment due to Alzheimer's Disease (AD) or mild Alzheimer's dementia.
- •Evidence of amyloid pathology confirmed by plasma phosphorylated tau217 (P-tau217) levels.
- •A Mini Mental State Examination (MMSE) score of 20 to 28 (inclusive).
- •Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant, and will accompany the participant to study visits or be available by telephone at designated times.
排除标准
- •Have significant neurological disease affecting the central nervous system other than AD.
- •Have a condition that in the investigator's opinion could interfere with the analyses of this study.
- •Have a life expectancy of less than 24 months.
- •Have a presence or history of malignant neoplasms within the past 5 years.
- •Are actively suicidal.
- •Have a diagnosis of alcohol or drug use disorder, except tobacco use disorder.
- •Have a history of clinically significant multiple or severe drug allergies, significant atopy, or severe posttreatment hypersensitivity.
- •Have previously received or are currently receiving treatment with a passive antiamyloid immunotherapy.
- •Have received active immunization against amyloid-beta (Aβ) in any other study.
- •Have known allergies to donanemab, related compounds, or any components of the formulation.
- •Have any clinically important abnormality at screening.
- •Screening magnetic resonance imaging (MRI) that 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 an MRI demonstrating presence of amyloid-related imaging abnormalities that show cerebral edema (ARIA-E), greater than (>) 4 cerebral microhemorrhages, more than 1 area of cortical superficial siderosis, any macrohemorrhage, or severe white matter disease.
- •Have any contraindications for MRI, including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants or a cardiac pacemaker.
- •Poor venous access.
- •Alanine aminotransferase (ALT) ≥2.5× upper limit of normal (ULN) of the performing laboratory, aspartate aminotransferase (AST) ≥2.5× ULN, total bilirubin (TBL) ≥1.5× ULN, or alkaline phosphatase (ALP) ≥2× ULN at screening.
研究组 & 干预措施
Donanemab
Experimental
Donanemab administered intravenously (IV)
干预措施: Donanemab (Drug)
结局指标
主要结局
Number of Participants with Any Occurrence of Amyloid-Related Imaging Abnormalities (ARIA)
时间窗: Baseline Up to Week 24, 52
Frequency and Severity of Infusion-Related Reactions
时间窗: Through Week 52
次要结局
- Change from Baseline in Mini Mental State Examination (MMSE) Score(Baseline through Week 76)
- Change from Baseline in Plasma Phosphorylated Tau217 (P-tau217)(Baseline through Week 76)
研究者
研究点 (9)
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