MCI, AD an CAA, CBS, PSP, iPD and DLB, ALS, NPH, and HC
Conditions
Interventions
Venipuncture and radiopharmaceutical administration in PET studies in healthy volunteers
Venipuncture and radiopharmaceutical administration in PET studies in patients volunteers
Sponsors
Niigata University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [Cognitively healthy volunteers] 1. 20 years of age or older at the time of obtaining consent. 2. Healthy adults who are determined to be eligible for the study by the investigator or sub-investigator's examination. [Patient volunteers] 1. 20 years of age or older at the time of obtaining consent. 2. The diagnostic criteria for each disease are as follows. 1) MCI: Those who meet the diagnostic criteria by Petersen 2) AD: Those who meet the 2011 NIA-AA criteria 3) CBS: Those who meet the diagnostic criteria of Mayo clinic and/or modified Cambridge diagnostic criteria 4) PSP: Those who meet the MDS PSP diagnostic criteria and/or the diagnostic criteria by Kanazawa 5) FTLD: Those who meet the diagnostic criteria by Neary and/or are diagnosed as frontotemporal dementia and parkinsonism linked to chromosome 17 (FTDP-17) with microtubule-associated protein tau (MAPT) mutation by genetic testing (including unaffected carriers) 6) PD and DLB: Those who meet the MDS diagnostic criteria or the diagnostic criteria by McKeith. However, in order to evaluate brain pathology including atypical cases, relative exclusion criteria ("red flags") should be allowed in the diagnosis of PD, and items related to relative exclusion criteria should be omitted in the diagnosis. 7) ALS: Those who meet the revised El Esocrial criteria 8) iNPH: Those who meet the diagnostic criteria of guidelines for management of idiopathic normal pressure hydrocephalus (second edition)
Exclusion criteria
Exclusion criteria: [Cognitively healthy volunteers] 1. Subjects with a history of or complications from organic brain diseases (consciousness disturbance, head trauma requiring hospitalization, obvious cerebral infarction or intracranial hemorrhage, etc.) 2. Subjects with substance-related disorders 3. Subjects with severe physical complications/disorders or a history of such conditions 4. Subjects with pacemakers or internal metal (brain clips, bolts, etc.) 5. Subjects with tattoos (including tattoos and art makeup) 6. Subjects with claustrophobia 7. Pregnant, possibly pregnant or lactating women 8. Subjects who are deemed inappropriate to participate in the study by the principal investigator or subcontractor [Patient volunteers] 1. Subjects with severe physical complications/disorders or a history of such conditions 2. Subjects with substance-related disorders 3. Subjects with claustrophobia 4. Pregnant, possibly pregnant or lactating women 5. Subjects who are deemed inappropriate to participate in the study by the principal investigator or subcontractor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brain reginal distribution volume and binding capacity of 18F-PM-PBB3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Association between neurological symptoms and neurological pathologies/damage assessed by 18F-PM-PBB3 and 18F-flutemetamol or 11C-PiB PET, MRI and fluid biomarkers | — |
Countries
Japan
Contacts
Public ContactHitoshi Shimada
Brain Research Institute, Niigata University Department of Functional Neurology & Neurosurgery, Center for Integrated Human Brain Science
Outcome results
None listed