Amyloid tau protein and brain structure network

JRCT ID: jRCTs031210318

Registered date:16/09/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Mild cognitive impairment or Alzheime's disease
• Date of first enrollment: 16/09/2021
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Pathophysiological diagnosis using PET

Outcome(s)

Primary Outcome

1) 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 Outcome: Safety of 18F-MK6240 and 18F-NAV4694

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

1) 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 criteria

1) 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

• Primary Sponsor: Matsuda Hiroshi