NCT03510572已完成早期 1 期
Clinical Evaluation of [18F]PI-2620 Positron Emission Computed Tomography for Imaging Tau Protein in Patients With Tauopathies and Healthy Volunteers: Phase 0 Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cross-sectional [18F]PI-2620 Imaging Results
研究概览
简要总结
The overall goal of this imaging trial is to evaluate [18F]PI-2620, a tau targeted positron emission computed tomography radioligand, in individuals with tauopathies and healthy volunteers (HV).
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 80 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 < 80 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 Healthy Subjects
- •Subjects with Alzheimer's disease
- •Subjects with frontotemporal dementia
- •Subjects with Parkinson's 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 30 days prior to the screening visit.
- •Cognitively Healthy Subjects
- •Subjects with Alzheimer's disease
- •Subjects with frontotemporal dementia
- •Subjects with Parkinson's disease
研究组 & 干预措施
Healthy volunteer
Experimental
Cognitively healthy subjects will receive a single IV injection of [18F]PI-2620.
干预措施: [18F]PI-2620 (Drug)
Alzheimer's Disease
Experimental
Alzheimer's Disease Subjects will receive a single IV injection of [18F]PI-2620.
干预措施: [18F]PI-2620 (Drug)
Frontotemporal dementia
Experimental
frontotemporal dementia Subjects will receive a single IV injection of [18F]PI-2620.
干预措施: [18F]PI-2620 (Drug)
Parkinson's disease
Experimental
Parkinson's disease Subjects 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 [18F]PI-2620 Imaging Results
时间窗: 60-90 minutes post injection
Compare Standard uptake value ratio (SUVR) and distribution of \[18F\]PI-2620 in subjects with tauopathies and cognitively healthy individuals.
.Assess the rate of change of tau deposition as measured by [18F]PI-2620 uptake (SUVR) over time
时间窗: 60-90 minutes post injection
Compare Standard uptake value ratio (SUVR) and distribution of \[18F\]PI-2620 in subjects with tauopathies and cognitively healthy individuals.
次要结局
- Correlation between standard uptake value ratio (SUVR) of [18F]PI-2620 positron emission computed tomography and neuropsychiatric test scores(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)
研究者
Jae Seung Kim
Professor
Asan Medical Center
研究点 (1)
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