A clinical trial to examine age-and-sex-related changes of AMPA receptor density in healthy volunteers.

A transversal PET study using [11C]K-2 to investigate age-and-sex-related changes AMPA receptor density in healthy volunteers.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031200083

Enrollment

100

Registered

2020-08-12

Start date

2020-08-12

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

Healthy volunteers

Interventions

Administration of unapproved drug

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: We will target healthy volunteers who meet all the following conditions. 1.Males and females between 20 and 70 years old at the time of obtaining informed consent. 2.No history of mental or neurological disease. 3.Sufficient consent judgment ability of the person in the evaluation by MacCAT. 4.No current mental disorders without meeting any criteria in SCID-I /DSM-IV,DSM-5, ICD-10.

Exclusion criteria

Exclusion criteria: 1. Person with psychotropic drugs, antidepressant, hypnotic, anxiolytic, antipsychotic. 2. Pregnant, lactating female. 3. Hypersensitive to ethanol. 4. neurolog ical disease (neurodegenerative disease, minor cerebral hemorrhage or cerebral infarction) 5. History of malignant brain tumor 6. History of epilepsy 7. Under medical treatment for other diseases 8. Substance-related disorders within 6 months except for nicotine and caffeine 9. Positive urine recreational drug screening (excluding person who takes the drugs for medication purposes) 10. Pacemaker or any metal devices in the body 11. Head, neck and body size are not suitable for MRI scanner 12. Big tattoo and art makeup on their skin 13. Severe claustrophobia 14. Congenital or traumatic brain abnormalities 15.Any of the following abnormal laboratory test values Serum creatinine 1.5mg / dl or more AST 150IU/L or more ALT 150IU/L or more 16. Person who have taken [11C] K-2 PET in other clinical trials. 17. Participants with unapproved nuclear medicine tests or clinical trials within 6 months before registration 18. Participants of other clinical trials or clinical trials within 12 weeks prior to enrollment (limited to those with invasion/intervention) 19. other reasons by the investigator

Design outcomes

Primary

Measure	Time frame
Age-and-sex-related density changes of AMPA receptor in healthy volunteers	—

Secondary

Measure	Time frame
Correlation between SUVR and LGA-BPND in each age group Correlation between SUVR and LGA-BPND difference by sex Correlation between age, SUVR, and LGA-BPND Correlation between sex, SUVR, and LGA-BPND Correlation between SUVR, LGA-BPND with partial volume effect correction and SUVR, LGA-BPND without partial volume effect correction Correlation between measurement value obtained from MRI examination, SUVR and LGA-BPND Adverse events until 7 days after [11C] K-2 administration Correlation between Mental symptom evaluation item scores and SUVR	—

Measure

Time frame

Correlation between SUVR and LGA-BPND in each age group Correlation between SUVR and LGA-BPND difference by sex Correlation between age, SUVR, and LGA-BPND Correlation between sex, SUVR, and LGA-BPND Correlation between SUVR, LGA-BPND with partial volume effect correction and SUVR, LGA-BPND without partial volume effect correction Correlation between measurement value obtained from MRI examination, SUVR and LGA-BPND Adverse events until 7 days after [11C] K-2 administration Correlation between Mental symptom evaluation item scores and SUVR

—

Contacts

Public ContactTsuyoshi Eiro

Yokohama City University, School of Medicine

eirotuyosi@gmail.com+81-45-787-2579

Outcome results

None listed

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