A clinical trial to examine the distribution of [11C]K-2 in patients with autism spectrum disorder.

JRCT ID: jRCTs031190149

Registered date:02/12/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Autism spectrum disorder
• Date of first enrollment: 18/02/2020
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Administration unapproved drug

Outcome(s)

• Primary Outcome: Correlation between AMPA receptor density and ADOS-2 score in right middle frontal gyrus and left upper frontal gyrus obtained by PET examination with [11C] K-2 in patients with autism spectrum disorder patients.

Secondary Outcome

1) Correlation between AMPA receptor density in brain and disease state image evaluated other than ADOS-2
2) Adverse events up to 7 days after [11C] K-2 administration.

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. Those who meets the criteria for Autism Spectrum Disorder (ASD) in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM5).
2. Men and women between 20 and 60 years old at the time of registration.
3. Patients who have given written consent to participate in this study.
4. Those who are judged to have sufficient consent judgment ability of the person in the evaluation by MacCAT.

Exclude criteria

It will be excluded if any of the following conditions apply.
1 During pregnancy, nursing or wishing to be pregnant(For premenopausal women,blood hCG is measured by blood sampling and confirmed to be less than 6 mIU/ml)
2 Sensitive to alcohol
3 Combination of serious neurologic diseases (neurodegenerative diseases, cases of cerebral hemorrhage and cerebral infarction which are not slight in the image before this study participation)
4 History of epilepsy
5 Take Perranpanel, Topiramate within 4 weeks before registration
6 Substance-related disorders within 6 months (except for nicotine and caffeine)
7 Dependent substances positive by urine screening (except those who are positive for the medicine being taken for treatment)
8 Implantation of metal substances and pacemakers
9 head, neck and body size not suitable for MRI scanner
10 A tattoo larger than one point (including tattoo and art makeup)
11 Advanced claustrophobic
12 A remarkable variant of brain structure (including congenital and traumatic)
13 At the time of registration, any of the following laboratory test value abnormalities
Serum creatinine 1.5 mg / dl or more
AST 150 IU / L or more
ALT 150 IU / L or more
14 Participating in unapproved nuclear medicine clinical trials and clinical trials within 6 months prior to enrollment
15 Participating in other trials or clinical trials within 12 weeks prior to enrollment (limited to those with invasiveness / intervention)
16 Patients judged as inappropriate for study by the research investigator
17 Patients under IQ70 in WAIS-3 or WAIS-4

Related Information

• Primary Sponsor: Miyazaki Tomoyuki
• Secondary Sponsor: Takahashi Takuya
• Source(s) of Monetary Support: Strategic Research Program for Brain Science,Takeda Science Foundation,Support by promoting advanced medical care at Yokohama City University Hospital