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

JRCT ID: jRCTs031200083

Registered date:12/08/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Healthy volunteers
• Date of first enrollment: 05/10/2020
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Administration of unapproved drug

Outcome(s)

• Primary Outcome: Age-and-sex-related density changes of AMPA receptor in healthy volunteers

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 70age old
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Abe Hiroki
• Secondary Sponsor: Takahashi Takuya
• Source(s) of Monetary Support: Strategic Research Program for Brain Science,Takeda Science Foundation,Japan Society for the Promotion of Science