JPRN-jRCTs031230306招募中Unknown
An exploratory study to obtain PET images with the unapproved radiation probe [11C]K-2 from patients with persistent cognitive sequelae after COVID-19 and to compare AMPA receptor expression density in the brain with that of age-control healthy subjects from a previous study (jRCTs031200083)
Eiro Tsuyoshi0 个研究点目标入组 30 人开始时间: 2023年8月24日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 60age old（—）
- 性别
- All
入选标准
- •We will target cases that meet all the following conditions.
- •1. Men and women between 20 and 60 years of age at the time of consent
- •2. Patients of whose clinical findings such as fever and upper respiratory tract symptoms confirm the diagnosis of SARS-CoV-2 infection by a physician, or those who were confirmed positive by a PCR test or antigen test at a medical institution at the time of SARS-CoV-2 infection
- •3. Patients of whose cognitive sequelae have persisted for more than 2 months after infection and whose symptoms are still persistent at the time of consent, and who have difficulty in working, attending school, or living.
- •4. Patients with an age-adjusted score (mean 100, standard deviation 15) of 85 or less on the RBANS neuropsychological test or an index score (sub-item) of -1 SD or less on the RBANS neuropsychological test
- •5. Patients who have been assessed as competent to give consent by the MacArthur Competence Assessment Tool (MacCAT), and who have given written consent to participate in this study, or who can obtain written consent from a surrogate.
排除标准
- •It will be excluded if any of the following conditions apply.
- •1. Whose history of SARS-CoV-2 infection cannot be confirmed by PCR test results or antigen test results
- •2. Pregnant, lactating or intending to become pregnant during the period of participation in the study
- •3. Whose blood hCG level was measured and confirmed to be 6 mIU/ml or higher
- •4. Who are hypersensitive to alcohol
- •5. Whose blood test results for AST, ALT, or ALP are 2.5 times or more than the institutional upper limit or whose serum Cr is 2.0 mg/dl or more
- •6. Those diagnosed with epilepsy at any time before or after SARS-CoV-2 infection
- •7. Those diagnosed with psychiatric disorders at any time before or after SARS-CoV-2 infection
- •8. Those diagnosed with neurological diseases at any time before and after SARS-CoV-2 infection
- •9. Those diagnosed with substance-related disorders (excluding nicotine and caffeine-induced disorders) at all times before and after SARS-CoV-2 infection
- •10. Who have a urine screening test positive for a substance of dependence (excluding drugs taken for treatment)
- •11. Who is required to continue taking perampanel or topiramate
- •12. Who are not suitable for 3 Tesla MRI imaging (have metal implants in the body that are not compatible with 3 Tesla MRI, tattoos (including art makeup) larger than one point, severe claustrophobia, or body shape that is not compatible with the MRI scanner)
- •13. Who may receive unapproved treatments or tests in other clinical trials or clinical studies during the period of participation in this study
- •14. Any other person who is deemed inappropriate as a research subject by the principal investigator or a research assistant investigator
研究者
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