801H research

JRCT ID: jRCTs031240528

Registered date:06/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: synucleinopathy
• Date of first enrollment: 06/12/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Administration of [11C]BIIB021 injection, PET scan, Head MRI scan, Blood tests, Cognitive function tests (only in Step2)

Outcome(s)

Primary Outcome

1. Clinical safety of the [11C]BIIB021 injection
2. Systemic kinetics of [11C]BIIB021
3. Accuracy of measuring the distribution volume of [11C]BIIB021

Secondary Outcome

1. Effective dose per unit of radioactivity administered for [11C]BIIB021 injection
2. Gender differences in the distribution volume of [11C]BIIB021
3. Relationship between the distribution volume of [11C]BIIB021 and psychological measures

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 40age old
• Gender: Both

Include criteria

1. A person whose age is 20 years or older but under 40 at the time of obtaining consent. Gender does not matter.
2. A person who applies voluntarily and is judged by the principal investigator or co-investigator to be capable of understanding the content of the explanatory document.

Exclude criteria

1. A person who has a disease or medical history that is judged by the investigators to affect the PET scan.
2. A person who, during a head MRI scan, is found to have findings suspected of affecting the PET scan (such as a history of clear cerebral infarction or cerebral hemorrhage).
3. A person who exhibits obvious abnormalities in the physical examination, blood/urine tests, or cognitive function tests (only for step 2) during eligibility evaluation, and is judged by the investigator(s) to either affect the PET scan or be at a higher-than-usual risk of health harm from undergoing the PET scan.
4. A person who is judged to be unable to remain still during the examination.
5. A person with internal magnetic metal (including tattoos, cosmetic tattoos, pacemakers, etc.).
6. A person with severe claustrophobia.
7. A person with a history of drug allergies.
8. A person who is pregnant, may be pregnant, or is currently breastfeeding.
9. A person who participated in another interventional clinical study and received the intervention within one year prior to the time of obtaining consent.
10. Any other person judged by the investigators to be unsuitable as a subject for this study.

Related Information

• Primary Sponsor: Kimura Yasuyuki
• Source(s) of Monetary Support: National Center for Geriatrics and Gerontology