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Establishment of a (18)F-florbetaben PET normative database of Japanese nondemented subjects and its application to detection of early cortical amyloid deposition

Establishment of a (18)F-florbetaben PET normative database of Japanese nondemented subjects and its application to detection of early cortical amyloid deposition - Establishment of a (18)F-FBB PET normative database of Japanese nondemented subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000025420
Enrollment
120
Registered
2016-12-27
Start date
2017-01-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropsychiatric disorders with cortical amyloid deposition such as Alzheimer&#39

Interventions

Medical inquiry, physical examination, neuropsychological tests and brain MRI are performed before the inclusion of volunteers into this study. The detailed inclusion criteria are as follows: (1) Medi

Sponsors

Keio University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Aged 20 to 89 at the time of obtaining informed consent (2) Those who can accomplish all the medical and imaging procedures (3) MMSE score greater than or equal to 27 (4) Brain MRI results within normal limits for the subject's age (5) Those who can give written informed consent before participating in this study

Exclusion criteria

Exclusion criteria: (1) Women who are or may be pregnant, or breast-feeding women (2) History of alcohol abuse (3) History of receiving epileptic treatment (4) Education period less than or equal to 6 years (5) The subject is taking antidepressants or psychotropic drugs or receiving the long-time administration of sedative agents. (6) History of neuropsychiatric disorders that are known to cause cognition (7) The subject is critically ill and/or medically unstable (e.g. volunteers with advanced hepatic or renal dysfunction, or with severe endocrine metabolic disease) (8) The subject whose MRI shows that ischemic white matter disease and/or lacunar infarctions are beyond normal range according to the guideline from the Japan Brain Dock Society (9) The subject whose MRI shows space-occupying lesions, unexpected cerebrovascular disease, neurodegenerative disease or congenital abnormality in the brain (10) History of high amount of radiation exposure

Design outcomes

Primary

MeasureTime frame
Establishment of a (18)F-FBB PET normative database of Japanese nondemented subjects including young adults

Secondary

MeasureTime frame
Safety assessment on (18)F-FBB PET and age-related PET positivity in Japanese normal volunteers

Countries

Japan

Contacts

Public ContactTadaki Nakahara

Keio University School of Medicine Department of Diagnostic Radiology

nakahara@rad.med.keio.ac.jp03-5363-3837

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026