臨床研究等提出・公開システム

Efficacy and safety of [11C]BIIB021 as a PET imaging ligand for molecular chaperone in the brain (801H)

801H research
(801H)

Kimura Yasuyuki

National Center for Geriatrics and Gerontology

7-430 Morioka-cho Obu-shi, Aichi

yazkim@ncgg.go.jp

Kimura Yasuyuki

National Center for Geriatrics and Gerontology

7-430 Morioka-cho Obu-shi, Aichi

+81-562-46-2311

yazkim@ncgg.go.jp

Recruiting

Dec. 06, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

diagnostic purpose

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.

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.

Both

synucleinopathy

Administration of [11C]BIIB021 injection, PET scan, Head MRI scan, Blood tests, Cognitive function tests (only in Step2)

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

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

+81-43-206-4706

Nov. 29, 2024

Yes

After the completion of the study, anonymized data from individual participants obtained in this research may be provided to domestic and international researchers or companies for the purpose of reanalysis or meta-analysis, or may be registered in domestic and international databases for that purpose.

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