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

JRCT ID: jRCTs031230306

Registered date:24/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Long COVID
• Date of first enrollment: 02/11/2023
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Administration unapproved drug

Outcome(s)

• Primary Outcome: AMPA receptor density per voxel in the brain measured from [11C]K-2 PET

Secondary Outcome

(21 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 60age old
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Eiro Tsuyoshi
• Secondary Sponsor: Takuya Takahashi
• Source(s) of Monetary Support: Takeda Science Foundation,Crowdfunding (READYFOR)