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临床试验/NCT07569718
NCT07569718Enrolling By Invitation不适用

Effects of Adolescent Synaptic Pruning

Beatriz Luna1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
60
试验地点
1
主要终点
Non-invasive quantification of synaptic pruning

研究概览

简要总结

The study will use a PET-based measure of brain cell (neuron) connections (synapses) in young adults who have also obtained an MRI, to assess how the loss of brain cell connections (synaptic pruning) is captured by MRI-based measures. This will inform youth MRI studies to understand neurotypical brain development that can help identify abnormal trajectories as in mental illness.

详细描述

The loss of brain cell (neuron) connections (synapses) through human development, known as synaptic pruning, has been characterized in postmortem studies but how this proceeds in live humans as they age into adulthood is not well understood. This study will use the PET tracer [11C]UCB-J which provides a direct measure of synaptic density, in conjunction with previously acquired ultra-high field MRI, in a group of young adults in order to understand how standard MRI-based measures reflect changes in the density of synapses. PET [11C]UCB-J is known to measure the density of synaptic connections by measuring a protein (SV2A) present in synapses. A comparison of results from the current study with MRI-based measures of byproducts of synaptic membrane breakdown from childhood to early adulthood will allow assessment of how non-invasive MRI reflects synaptic pruning through development, facilitating studies of how the brain changes through adolescence and into adulthood, which is needed to identify patterns of development associated with the emergence of mental illness.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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

入选标准

  • Males or females between 18-26 years of age, AND currently enrolled in the Parent Project (R01MH067924)

排除标准

  • (these exclusion criteria are outlined in the Parent Project)
  • Head injury with loss of consciousness over an hour.
  • A vision problem or eye movement problem (such as lazy eye, double vision, blurred vision, or color blindness).
  • A learning disability and/or ever had an Individualized Education Plan (IEP) in school.
  • Significant neurological or metabolic illness: Epilepsy, Meningitis, Encephalitis, Diabetes, Huntington's disease.
  • Diagnosed with a psychiatric disorder.
  • Participants with, or with a first degree relative, having a DSM IV Axis l psychiatricdisorder.
  • Metal implants or ferromagnetic objects contained within the body which may interfere with the MRI scan (but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant.) Dental fillings do not present a risk for MRI. If there is a possibility of metal being present in the participant's body, the participant will be excluded from the study.
  • Weight more than 250 pounds.
  • Claustrophobia or uncomfortable in small spaces.
  • <70% on the Achenbach scale (either from Youth Self Report (YSR) or Adult Self Report (ASR)).
  • IQ < 80 or IQ >
  • Pregnancy or lactation, lack of effective birth control during 15 days before the scans.
  • Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year such that the total cumulative annual radiation dose (i.e., from participation in the previous radioactive drug study [studies] and this study) would exceed the radiation dose limits specified in the FDA regulations (i.e., 21 CFR 361.1) that govern the research use of [C-11]UCB-J
  • History of drug or alcohol abuse (from parent study eligibility).

研究组 & 干预措施

PET Imaging Supplemental Component

Experimental

Adult participants enrolled in the parent study, will be given the option to be a part of the PET imaging supplemental project. Maximum enrollment is 60 adult participants. Interested participants will be consented into the PET portion, and will have a single PET scan (as outlined in the Study Description section).

干预措施: PET Imaging Scan using [11C]UCB-J (Radiation)

结局指标

主要结局

Non-invasive quantification of synaptic pruning

时间窗: The PET-CT scan will be within approximately 30 days of the parent study MRI.

1\. Age-related changes in synaptic density through young adulthood o Cross-sectional age-related (18-26 years of age) changes in synaptic density via SUVR quantified within the dorsolateral prefrontal cortex.

次要结局

未报告次要终点

研究者

发起方
Beatriz Luna
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Beatriz Luna

Professor

University of Pittsburgh

研究点 (1)

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