Efficacy and safety of [11C]NCGG401

JRCT ID: jRCTs031210249

Registered date:18/08/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Alzheimer's disease
• Date of first enrollment: 18/08/2021
• Target sample size: 9
• Study type: Interventional
• Intervention(s): Injection of [11C]NCGG401 and PET scans

Outcome(s)

Primary Outcome

Clinical Safety of [11C]NCGG401 Injection
Systemic kinetics of [11C]NCGG401
Accuracy of Measurement of Volume of Distribution of [11C]NCGG401

Secondary Outcome

Effective dose per unit dose of radiation for [11C]NCGG401 injection solution
Correlation between volume of distribution of [11C]NCGG401 and volume of distribution of [11C]DPA-713
Correlation between volume of distribution of [11C]NCGG401 and blood markers.
Effect of single nucleotide polymorphism of CSF1R on the volume of distribution of [11C]NCGG401

Key inclusion & exclusion criteria

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

Include criteria

1) Males who are between 20 and 40 years old at the time of consent.
2) A person who voluntarily applies for the study and is judged by the principal investigator or sub-investigator to be able to understand the contents of the explanatory document.

Exclude criteria

1) Patients with obvious abnormality in the clinical examination conducted after obtaining consent.
2) Patients whose head MRI scan revealed findings that are suspected to affect the PET scan (such as a clear history of cerebral infarction or cerebral hemorrhage).
3)Those whose cognitive or intellectual functioning is below the normal range on psychological testing, and those whose developmental or mental status is considered to interfere with testing (Step 2 only).
4) Those who have magnetic metals in their body (tattoos, tattoos including art makeup, pacemakers, etc.).
5) Those who are highly claustrophobic.
6) Those who have a history of drug allergy.
7) Those who have serious complications or those who have a history of such complications and are judged by the principal investigator or sub-investigator to be ineligible for this study.
8) Subjects who are regularly taking steroidal or non-steroidal anti-inflammatory drugs.
9) Those who have participated in other clinical research involving intervention for less than one year from the time of obtaining consent.
10) Those who have participated in nuclear medicine examinations of other healthy volunteers for less than 6 months from the time of obtaining consent, in view of radiation exposure in nuclear medicine examinations.
11) Those who have not consented to the storage of specimens in our biobank.
12) Any other person who is judged by the principal investigator or sub-investigator to be ineligible as a subject of this study.

Related Information

• Primary Sponsor: Kimura Yasuyuki