NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031210318

Registered date:16/09/2021

Amyloid tau protein and brain structure network

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedMild cognitive impairment or Alzheime's disease
Date of first enrollment16/09/2021
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Pathophysiological diagnosis using PET

Outcome(s)

Primary Outcome1) Quantitative evaluation of amyloid beta protein with 18F-NAV4694 PET 2)Quantitative evaluation of tau protein with 18F-MK6240 PET 3)Structural network analysis and production of each parametric image from 3D T1WI brain MRI 4)Correlation analysis of each structural network parametric image with accumulation of Abeta and tau protein
Secondary OutcomeSafety of 18F-MK6240 and 18F-NAV4694

Key inclusion & exclusion criteria

Age minimum>= 40age old
Age maximum< 90age old
GenderBoth
Include criteria1) Those who have cognitive impairment suspected of having MCI and early AD based on the diagnostic criteria of NIA-AA or DSM-5 2) 40 to 90 years old, regardless of gender 3) A person who can obtain written consent from the person or his / her substitute. 4) MRI imaging including 3DT1 weighted image has already been performed within 90 days at the time of obtaining consent.
Exclude criteria1) Those who have gross lesions (brain tumor, cerebral vascular malformation, cortical infarction, etc.) on brain MRI. 2) Those who have serious complications, or those who have a history of these and are judged by the investigator and the investigator to be ineligible for this study. 3) In addition, those who are judged by the principal investigator and the investigator to be ineligible for this study.

Related Information

Contact

Public contact
Name Hiroshi Matsuda
Address 7-61-2 Yatsuyamada Koriyama-shi Fukushima, Japan Hukushima Japan 963-8052
Telephone +81-24-934-5610
E-mail hiroshi.matsuda@mt.strins.or.jp
Affiliation The Research Institute for Neuroscience Southern Tohoku Drug Discovery and Cyclotron Research Center
Scientific contact
Name Hiroshi Matsuda
Address 7-61-2 Yatsuyamada Koriyama-shi Fukushima, Japan Hukushima Japan 963-8052
Telephone +81-24-934-5610
E-mail hiroshi.matsuda@mt.strins.or.jp
Affiliation The Research Institute for Neuroscience Southern Tohoku Drug Discovery and Cyclotron Research Center