NCT03903211已完成2 期
Longitudinal Changes of [18F]PI-2620 Positron Emission Tomography in Subjectives With Cognitively Normal, Mild Cognitive Impairment and Alzheimer's Disease
Jae Seung Kim1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2019年4月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Cross-sectional PI-2620 uptake measured by standard uptake value ratio (SUVR)
研究概览
简要总结
The overall goal of this imaging trial is to evaluate crosssectional difference and longitudinal changes of [18F]PI-2620, a tau targeted positron emission computed tomography radioligand, in cognitively normal individuals, and subjects with mild cognitive impairment and Alzheimer's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •General Subject Inclusion Criteria
- •In order to be eligible for participation in this trial, the subject must:
- •Be ≥ 40 and < 85 years of age at the Screening Visit.
- •Be able to read at a 6th grade level or equivalent, (as determined by the investigator, and must have a history of academic achievement and/or employment sufficient to exclude mental retardation.)
- •Be able to speak, read, hear, and understand the language of the trial staff, and the informed consent form, and possess the ability to respond verbally to questions, follow instructions, and complete questionnaires and detailed neuropsychological test.
- •Have results of clinical laboratory tests/physical examination, vital signs, and ECG within normal limits (at 90 days prior to [18F]PI-2620 positron emission computed tomography) or clinically acceptable to the investigator at screening.
- •If female, not be of childbearing potential as indicated by one of the following
- •Each subject (or legal representative) must sign the informed consent form in accordance with local requirements after the scope and nature of the investigation have been explained to them, and before screening assessments.
- •Cognitively normal individuals
- •Subjects with Mild Cognitive Impairment
- •Subjects with Alzheimer Disease
排除标准
- •The subject must be excluded from participating in the trial if the subject fulfil any single criteria described below:
- •General Exclusion Criteria
- •Based on the investigators' judgement, if the patient is not capable of communicating with the site personnel, if the patient is not proficient in the language in which the psychometric tests will be completed, or if the patient is not sufficient for compliance with the study procedures.
- •The patient has an abnormal physical examination or abnormal laboratory test results at the screening that are clinically significant to affect results of the research, as judged by the investigator.
- •If the patient has or is suspicious of having a hypersensitivity or allergy to [18F] PI-2620 or its derivatives.
- •The patient is pregnant, is attempting to become pregnant, or is nursing (breast-feeding) children.
- •The patient has a history of alcoholism or drug dependency/abuse within the last 2 years before screening.
- •The patient has contraindications to undergo positron emission computed tomography or MRI, which include but are not restricted to the examples below: claustrophobia, cardiac pacemaker, metal devices around the eye or spinal cord, cochlear implant, etc.) at the screening visit.
- •The patient has been treated with any investigational medicinal product (IMP) within 1 years prior to the screening visit.
- •Cognitively normal individuals
- •Subjects with Mild Cognitive Impairment
- •Subjects with Alzheimer Disease
研究组 & 干预措施
Cognitively normal individuals
Experimental
Cognitively normal individualswill receive a single IV injection of [18F]PI-2620.
干预措施: [18F]PI-2620 (Drug)
Subjects with Mild Cognitive Impairment
Experimental
Subjects with Mild Cognitive Impairment will receive a single IV injection of [18F]PI-2620.
干预措施: [18F]PI-2620 (Drug)
Subjects with Alzheimer Disease
Experimental
Alzheimer Disease Subjects with Alzheimer Disease will receive a single IV injection of [18F]PI-2620.
干预措施: [18F]PI-2620 (Drug)
结局指标
主要结局
Cross-sectional PI-2620 uptake measured by standard uptake value ratio (SUVR)
时间窗: 60-90 minutes post injection
Cross-sectional PI-2620 uptake measured by standard uptake value ratio (SUVR) in Cognitively normal, Mild Cognitive Impairment and Alzheimer Disease.
次要结局
- Changes of PI-2620 uptake over time measured by standard uptake value ratios (SUVR)(60-90 minutes post injection)
- Correlation between standard uptake value ratio (SUVR) of [18F]PI-2620 positron emission computed tomography and indices of structural MRI(60-90 minutes post injection)
- Correlation between standard uptake value ratio (SUVR) of [18F]PI-2620 positron emission computed tomography and neuropsychiatric test scores(60-90 minutes post-injectio)
研究者
Jae Seung Kim
Principal Investigator
Asan Medical Center
研究点 (1)
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