NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031210249

Registered date:18/08/2021

Efficacy and safety of [11C]NCGG401

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedAlzheimer's disease
Date of first enrollment18/08/2021
Target sample size9
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Injection of [11C]NCGG401 and PET scans

Outcome(s)

Primary OutcomeClinical Safety of [11C]NCGG401 Injection Systemic kinetics of [11C]NCGG401 Accuracy of Measurement of Volume of Distribution of [11C]NCGG401
Secondary OutcomeEffective 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
GenderMale
Include criteria1) 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 criteria1) Patients with obvious abnormality in the clinical examination conducted after obtaining consent. 2) Patients with suspected abnormalities (e.g., history of cerebral infarction, cerebral hemorrhage, etc.) found in a head MRI scan. 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

Contact

Public contact
Name Yasuyuki Kimura
Address 7-430 Morioka-cho, Obu City, Aichi Prefecture, Japan Aichi Japan 474-8511
Telephone +81-562-46-2311
E-mail yazkim@ncgg.go.jp
Affiliation National Center for Geriatrics and Gerontology
Scientific contact
Name Yasuyuki Kimura
Address 7-430 Morioka-cho, Obu City, Aichi Prefecture, Japan Aichi Japan 474-8511
Telephone +81-562-46-2311
E-mail yazkim@ncgg.go.jp
Affiliation National Center for Geriatrics and Gerontology