Evaluations of chronic neuroinflammation and tau accumulations secondary to various CNS diseases; A PET and postmortem study

UMIN ID: UMIN000054601

Registered date:12/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Traumatic brain injury, CNS infectious diseases, Autoimmune encephalitis, Epilepsy, Chemical brain injury, Neurosurgery
• Date of first enrollment: 2024/06/20
• Target sample size: 190
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Neuroimaging assessment including PET scans
Neuropsychological tests

Outcome(s)

• Primary Outcome: Regional MAO-B density quantified by PET with 11C-SL25.1188 in patients and healthy volunteers
• Secondary Outcome: Regional tau accumulation quantified by PET with 18F-florzolotau in patients and healthy volunteers Quantity and distribution of tau pathology assessed by histopathology and autoradiography

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Patients group 1 Patients receiving dialysis 2 Patients who have or have had complications of serious physical diseases and are considered to be unsuitable for this study 3 Patients with severe claustrophobia 4 Pregnant, possibly pregnant, or lactating patients 5 Patients who are participating in other clinical trials, including clinical trials, research to which the Clinical Research Act applies or research to which ethical guidelines apply. 6 Patients within 3 months of blood donation 7 Allergic to local anesthetics or anticoagulants 8 Patients taking anticoagulants 9 Patients taking MAO-B inhibitors 10 Patients who regularly use health products with curcumin as an active ingredient 11 Patients who are unable to undergo MRI scanning 12 Others who are considered to be inappropriate as research subjects by the researcher Normal volunteers 1 Persons with a history of or complications from organic brain disease (disorders of consciousness, head trauma requiring hospitalizat cerebral hemorrhage, etc.) 2 Persons with substance-related disorders (drug dependence, etc.) 3 Persons undergoing dialysis 4 Persons who have or have had complications of serious physical diseases and are considered to be unsuitable for this study 5 Persons with severe claustrophobia 6 Pregnant, possibly pregnant, or lactating persons 7 Persons who are participating in other clinical trials, including clinical trials, research to which the Clinical Research Act applies, or research to which ethical guidelines apply. 8 Persons within 3 months of blood donation 9 Allergic to local anesthetics or anticoagulants 10 Persons taking anticoagulants 11 Persons taking MAO-B inhibitors 12 Persons who regularly use health products with curcumin as an active ingredient 13 Persons who are unable to undergo MRI scanning 14 Others who are considered to be inappropriate as research subjects by the researcher

Related Information

• Primary Sponsor: National Institutes for Quantum Science and Technology
• Secondary Sponsor: National Center for Neurology and Psychiatry, Brain Research Institute Niigata University, National Hospital Oganizetion Simofusa Psychiatric Center
• Source(s) of Monetary Support: National Institutes for Quantum Science and Technology