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Investigation for efficacy and safety of tau PET ligand [18F]PM-PBB3

Investigation for efficacy and safety of tau PET ligand [18F]PM-PBB3 - Investigation for efficacy and safety of tau PET ligand [18F]PM-PBB3

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000026490
Enrollment
20
Registered
2017-03-13
Start date
2017-03-20
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

Alzheimer&#39

Interventions

1) PET ligand: [18F]PM-PBB3 administration dose: 5mCi number of dose: single dose 2) PET ligand: [11C]PBB3 administration dose: (body weight(kg)/5)mCi number of dose: single dose 3)

Sponsors

National Institute of Radiological Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (efficacy assessment) Healthy subjects: 1. Healthy subjects who have the ability to consent to participate in this study 2. 20 years of age or older at the time of obtaining consent Dementia subjects: 1. 20 years of age or older at the time of obtaining consent. 2. Subjects who can be accompanied by a legal guardian on the day of study participation at the NIRS. 3. AD, MCI: Subjects meeting the inclusion criteria in the J-ADNI core study except for age. However, the range of CDR (Clinical dementia rating) in patients with AD will be 0.5-2, and the range of MMSE (Mini Mental State Examination) will be 26 points or less PSP:Subjects meeting the criteria of NINDS-SPSP CBS: Subjects meeting the criteria of Mayo clinic and/or Cambridge (exposure dose assessment) 1. Healthy subjects who have the ability to consent to participate in this study 2. 50 years of age or older at the time of obtaining consent

Exclusion criteria

Exclusion criteria: 1. Subjects who show obviously abnormal blood data at 1st day of the study 2. Subjects with organic brain complications/disorders (including a history of traumatic brain injury with loss of consciousness and/or hospital treatment, symptomatic cerebral infarction or hemorrhage) 3. Patients with substance-related disorders (including drug abuse) 4. Subjects with severe physical complications/disorders or a history of such conditions and who are considered to be inappropriate for participation by the aforementioned doctors with responsibilities in this study 5. Subjects with a pacemaker or other metallic medical device in the body (brain clip, bolts, etc.) 6. Subjects with tattoos 7. Subjects with claustrophobia 8. Pregnant, possibly pregnant or lactating women 9. From the standpoint of radiation exposure from a nuclear medicine scan, subjects who have participated in other nuclear medicine scans as healthy volunteers in the 12 months prior to the start of this study 10. Subjects who are considered to be inappropriate for participation by doctors with responsibilities in this study

Design outcomes

Primary

MeasureTime frame
Pharmacokinetic and quantitative analysis of [18F]PM-PBB3 Effective dose of [18F]PM-PBB3

Countries

Japan

Contacts

Public ContactKazuko Suzuki

National Institute of Radiological Sciences Clinical Research Support Section

suzuki.kazuko@qst.go.jp81432063025

Outcome results

None listed

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