NCT05542953已完成3 期
A Phase 3, Multicenter Study of [18F]APN-1607 Positron Emission Tomography in Subjects With Alzheimer's Disease Compared to Healthy Subjects
APRINOIA Therapeutics1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2022年1月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Assessment of [18F]APN-1607 Uptake Patterns by Regional SUVR Values
研究概览
简要总结
The overall objective of this study is to compare the overall pattern of [18F]APN-1607 uptake in subjects with MCI, subjects with AD dementia, and healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •Inclusion Criteria for All Subjects:
- •Written informed consent must be obtained before any assessment is performed.
- •Female subjects must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal ligation) or post-menopausal for at least 1 year (ie, 12 consecutive months with no menses without an alternative medical cause) or, if they are of childbearing potential, must commit to use a barrier contraception method or to abstinence for the duration of the study and must have negative serum and urine pregnancy tests.
- •Male subjects and their partners of childbearing potential must commit to the use of two methods of contraception, one of which is a barrier method (ie, condom), or to abstinence for the study duration.
- •Male subjects must not donate sperm for the study duration.
- •Willing and able to participate in all study procedures.
- •Inclusion Criteria for Healthy Subjects:
- •Medically healthy with no clinically relevant finding on physical examination, laboratory profiles, VS, or ECG at screening and upon reporting for the [18F]APN-1607 Imaging Visit.
- •No cognitive impairment based on neuropsychological battery and as judged by the Investigator.
- •No first-degree family history of early-onset AD or other neurological disease associated with dementia (prior to age 65).
- •Inclusion Criteria for Subjects with MCI:
- •Written informed consent must be obtained before any assessment is performed.
- •Must meet all of the clinical criteria for MCI according to NIA-AA criteria, including lack of functional impairment sufficient to warrant a diagnosis of dementia.
- •Inclusion Criteria for Subjects with AD:
- •Has a diagnosis of AD dementia according to NIA-AA criteria, including significant impairment of activities of daily living.
- •Medications taken for symptomatic treatment of AD must have been stable for 30 days prior to screening and through completion of the neuropsychological battery.
排除标准
- •Exclusion Criteria for All Subjects:
- •Current or prior history (within the last 10 years) of alcohol or drug abuse.
- •Known hypersensitivity to [18F]APN-1607 or its excipients.
- •Clinically significant active or unstable medical illness or planned surgical procedures during the study period. History of cancer (other than nonmelanoma skin cancers or stable, local prostate cancer), unless without evidence of active disease within the last 3 years and without ongoing medical or surgical therapy.
- •Laboratory tests with clinically significant abnormalities or a history or evidence of clinically significant unstable medical illness.
- •Prior participation in other research protocols or clinical care in the last year in addition to the radiation exposure expected from participation in this clinical study, such that radiation exposure exceeds local guidelines.
- •Pregnant, lactating or breastfeeding.
- •Unsuitable veins for repeated venipuncture.
- •Implants, or history of claustrophobia in MRI.
研究组 & 干预措施
Alzheimer's Disease
Experimental
AD subjects will undergo PET imaging using [18F]APN-1607.
干预措施: [18F]APN-1607 (Drug)
Mild Cognitive Impairment Due to Alzheimer's Disease
Experimental
MCI subjects will undergo PET imaging using [18F]APN-1607.
干预措施: [18F]APN-1607 (Drug)
Healthy Volunteers
Experimental
Healthy control subjects will undergo PET imaging using [18F]APN-1607.
干预措施: [18F]APN-1607 (Drug)
结局指标
主要结局
Assessment of [18F]APN-1607 Uptake Patterns by Regional SUVR Values
时间窗: 15 months
Regional \[18F\]APN-1607 uptake patterns will be assessed in regions of interest (ROIs) and an iROI that are relevant to AD pathology. \[18F\]APN-1607 uptake patterns identified by regional analysis will be compared among healthy subjects, subjects with MDAD, and subjects with AD dementia. Standard uptake value (SUV) will be calculated for each ROI, and SUVRs will be calculated by normalizing SUV of ROIs to the SUV of relevant reference region.
次要结局
- Safety and Tolerability Profile Measured by Adverse Events (AEs)(15 months)
研究者
研究点 (1)
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