NCT07598370招募中1 期
A Phase 1, Open Label, Multiple-Dose Study to Assess the Changes in Cerebrospinal Fluid Biomarkers for Alzheimer's Disease Following Treatment With LY3439539 in Participants With Symptomatic Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 13
- 主要终点
- Change from Baseline in Cerebrospinal Fluid (CSF) Neurofilament Light Chain (NfL)
研究概览
简要总结
The purpose of this study is to see how LY3439539 affects certain proteins found in the spinal fluid of participants with Alzheimer's disease.
Participation in the study will last approximately 9 months with visits about once a month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 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 change in memory function reported by the participant or informant for 6 months or longer consistent with a diagnosis of dementia due to Alzheimer's disease
- •Have a Mini Mental Score Examination score of 16 to 24, inclusive
- •Meet plasma pTau criteria, as defined by the sponsor
- •Have body mass index within the range of 17 and 32 kilograms per square meter (kg/m²) (inclusive) at screening
- •Are women not of childbearing potential and men willing to practice effective contraception throughout the study.
- •Have adequate premorbid literacy, vision, and hearing throughout the study duration and able to complete study procedures.
- •Have at least 1, and up to 2, study partners who are in frequent contact with the participant (defined as at least 10 hours per week).
排除标准
- •Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.
- •Have a screening MRI that shows evidence of significant abnormality.
- •Have history of suicidal behavior, or a lifetime history of suicide attempt or acute suicidality.
- •Have a history of
- •Severe or ongoing allergy or hypersensitivity reactions
- •Hypersensitivity to immunizations or immunoglobulins
- •Two or more clinically significant or severe drug allergies,
- •Intolerance to topical corticosteroids or severe posttreatment hypersensitivity reactions
- •Have current serious or unstable illnesses, including hepatic, renal, gastroenterological, respiratory, cardiovascular, neurologic (other than AD), psychiatric, endocrinologic, immunologic, hematologic disease, or other conditions
- •Require treatment with another monoclonal antibody or have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.
- •Have criteria that would preclude a lumbar puncture (LP).
- •Are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study.
- •Have a current exposure to amyloid-targeting therapies (ATTs). Prior exposure to ATTs greater than 1 year from the last dose may be permitted at the discretion of the investigator and in consultation with the sponsor.
研究组 & 干预措施
LY3439539
Experimental
LY3439539 administered intravenously (IV)
干预措施: LY3439539 (Drug)
结局指标
主要结局
Change from Baseline in Cerebrospinal Fluid (CSF) Neurofilament Light Chain (NfL)
时间窗: Baseline through end of the Follow-up Period (Week 24)
次要结局
- Change from Baseline in Phospho-Tau (pTau)(Baseline through end of the Follow-up Period (Week 24))
- Change from Baseline in Plasma NfL(Baseline through end of the Follow-up Period (Week 24))
- Pharmacokinetics (PK) Maximum LY3439539 Serum Concentration (Cmax)(Baseline through end of the Follow-up Period (Week 24))
- PK: Minimum LY3439539 Serum Concentration (Cmin)(Time Frame: Baseline through end of Follow up Period (Week 24))
研究者
研究点 (13)
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