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A clinical trial to determine the distribution of AMPA receptor density in patients with persistent cognitive sequelae after COVID-19 disease.

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)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031230306
Enrollment
30
Registered
2023-08-24
Start date
2023-08-24
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long COVID

Interventions

Sponsors

Eiro Tsuyoshi
Lead Sponsor
Takuya Takahashi
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
AMPA receptor density per voxel in the brain measured from [11C]K-2 PET

Secondary

MeasureTime frame
(1) AMPA receptor density per brain voxel measured from [11C]K-2 PET (white matter corrected) (2) AMPA receptor density per brain voxel (white matter corrected) and RBANS score measured from [11C]K-2PET (3) Blood fluid factor and AMPA receptor density per brain voxel (white matter corrected) measured from [11C]K-2 PET in Long-COVID patients (4) AMPA receptor density per brain voxel measured from blood fluid factor and [11C]K-2 PET in Long-COVID patients (5) AMPA receptor density per brain voxel measured from [11C]K-2 PET in Long-COVID patients with severe and mild cognitive sequelae (6) AMPA receptor density per brain voxel measured from [11C]K-2 PET in Long-COVID patients with severe and mild cognitive sequelae (white matter corrected) (7) Protein levels quantified by PEA method in Long-COVID patients with severe and mild cognitive sequelae (8) Correlation between SUVRWM and BPnd in Long-COVID patients (9) Correlation between SUVRWB and BPnd in Long-COVID patients

Contacts

Public ContactTsuyoshi Eiro

Yokohama City University Hospital

t196014a@yokohama-cu.ac.jp+81-45-787-2579

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026