A Phase 2, Open Label, Study of AMDX-2011P as a Retinal Tracer in Participants With Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Amydis Inc.
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- AMDX-2011P Adverse Events Profile
研究概览
简要总结
The purpose of this study is to assess safety, tolerability, plasma pharmacokinetics and biologic activity of a single intravenous dose of AMDX-2011P in participants with Alzheimer's Disease (AD).
详细描述
This open-label, masked endpoint assessment study will evaluate the safety, tolerability, plasma pharmacokinetics (PK) and biological activity of an intravenous (IV) dose of AMDX-2011P in participants with AD. Assessments of retinal images will be conducted by central masked assessors.
Participants will be admitted to the study site where eye examination and retinal imaging will be conducted before administration of the study drug. AMDX-2011P will be administered through a single IV bolus injection followed by safety assessments, retinal imaging and PK blood collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of Alzheimer's Disease (AD) with documented positive amyloid beta signal via positron emission tomography (PET) brain scan
- •Must be willing to consent to genotyping for apolipoprotein E (APOE)
- •Ability to fixate and undergo retinal imaging of both eyes
排除标准
- •Presence of any underlying physical or psychological medical condition that, in the opinion of the investigator, would make it unlikely that the participant will complete the study per protocol
- •Diagnosis of glaucoma, or suspect of having glaucoma in either eye as determined by an ophthalmologist as a clinical investigator, based on results from the eye examination, visual field, and/or optical coherence tomography (OCT) results
- •Diagnosis of intermediate dry, wet/neovascular, or geographic atrophy forms of age-related macular degeneration (AMD) in either eye, OR as determined by an ophthalmologist as a clinical investigator, based on results from the eye examination and/or optical coherence tomography (OCT) results
- •Clinically significant laboratory abnormalities as assessed by the investigator
- •Prolonged QTcF (corrected QT interval by Fridericia method) (>450 ms for males and >470 ms for females), cardiac arrhythmia, or any clinically significant abnormality in the resting electrocardiogram (ECG), as judged by the investigator.
研究组 & 干预措施
AMDX-2011P 100 milligram
AMDX2011P 100 milligram (4 milliliter) single bolus injection intravenous for diagnostic review
干预措施: AMDX-2011P (Drug)
结局指标
主要结局
AMDX-2011P Adverse Events Profile
时间窗: 8 days
Incidence, nature and severity of adverse events/serious adverse events (AEs/SAEs)
次要结局
- Pharmacokinetic Analysis of AMDX-2011P(2 hours)
- Concentration of AMDX-2011P(2 hours)
- Biological Activity(8 days)