FDDNP-PET Imaging in Persons at Risk for Chronic Traumatic Encephalopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Distribution Volume Ratio (DVR)
研究概览
简要总结
This project was designed to determine brain imaging patterns using 2-(1-{6-[(2-fluorine 18-labeled fluoroethyl)methylamino]-2-naphthyl}ethylidene)malononitrile ([F-18]FDDNP) with positron emission tomography (PET) in participants with suspected Chronic Traumatic Encephalopathy (CTE), a progressive degenerative disease of the brain found in people with a history of repetitive traumatic brain injuries (TBIs), characterized by personality, behavioral, and mood disturbances, cognitive impairment, and sometimes motor symptoms. Currently, CTE can only be definitely diagnosed from neuropathological examination of the brain after autopsy. Developing tools to assist in the detection of this condition in living individuals at risk would facilitate research focusing on discovering potential prevention and treatment strategies.
详细描述
The project involved clinical and neuropsychological evaluations of participants with histories of TBI and symptoms suggestive of CTE; performing [F-18]FDDNP-PET scans on those participants; determining if patterns of [F-18]FDDNP binding in the brain differ from those of normal controls and Alzheimer's dementia (AD) (available from other studies). Prior research has shown that [F-18]FDDNP-PET produces binding patterns in the brain that indicate high concentrations of tau neurofibrillary tangles (NFTs) and amyloid plaques (Small et al, 2006).
The investigators aimed to test the following hypothesis: [F-18]FDDNP-PET scans will demonstrate cerebral patterns of binding in participants with suspected CTE that differ from cerebral patterns observed in cognitively-intact control participants and participants with AD. The [F-18]FDDNP-PET binding patterns are expected to be consistent with known plaque and tangle deposition patterns from previous neuropathology studies.
[F-18]FDDNP is a PET molecular imaging probe with high in vitro binding affinity to amyloid plaques, NFTs and fibrillar tau deposits as shown with fluorescent microscopy with non-radioactive FDDNP.
In addition to the above hypothesis, neuropathological data from autopsy follow-up (when it becomes available) will be used to determine correlations between regional plaque and tangle deposition patterns observed in neuropathological studies with imaging results from [F-18]FDDNP scans.
Background:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Agreement to participate in study;
- •A history of TBI resulting from, but not limited to, any of the following: contact sports, accidents, violence, or military combat;
- •Age 18 or older;
- •No significant cerebrovascular disease;
- •Adequate visual and auditory acuity to allow neuropsychological testing;
- •Screening laboratory tests without significant abnormalities that might interfere with the study.
排除标准
- •Preexisting major neurological or other physical illness that could confound results (e.g., multiple sclerosis, diabetes, cancer);
- •History of myocardial infarction within the previous year or unstable cardiac disease.
- •Uncontrolled hypertension (systolic blood pressure > 170 or diastolic blood pressure > 100),
- •History of significant liver disease, clinically significant pulmonary disease, diabetes, or cancer.
- •Such current major psychiatric disorders as mania within the previous two years.
- •Participants taking drugs that are known to affect [F-18]FDDNP-PET binding (e.g., ibuprofen, naproxen) were asked to stop taking medication one week prior to PET scan or excluded from the study.
- •Use of any investigational drugs within the previous month, depending on drug half-life.
结局指标
主要结局
Distribution Volume Ratio (DVR)
时间窗: Baseline
The outcome measure is a ratio of the volume (in milliliters) of 2-(1-{6-\[(2-fluorine 18-labeled fluoroethyl)methylamino\]-2-naphthyl}ethylidene)malononitrile (\[F-18\]FDDNP) bound within the region of interest (ROI) divided by the amount of \[F-18\]FDDNP in the cerebellum (reference region). Higher ratios are indicative of higher levels of tau and amyloid proteins within the ROI. The unit of measure is called the Distribution Volume Ratio (DVR).
次要结局
未报告次要终点
研究者
Gary Small, MD
Principal Investigator
University of California, Los Angeles