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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000029084
Enrollment
20
Registered
2017-09-12
Start date
2015-12-17
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

Sponsors

National Institute of Radiological Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Healthy controls: 1. Subjects who are considered to be appropriate for participation by doctors with responsibilities in this study. 2. 20 years of age or older at the time of obtaining consent. Patients: 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. Subjects meeting the inclusion criteria in the J-ADNI core study except for age, and noticed the disease for clinical treatment. 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

Exclusion criteria

Exclusion criteria: 1. Subjects who show obviously abnormal blood data at the 1st day of the study. 2. Subjects with organic brain complications/disorders (including traumatic brain injury, a history of symptomatic cerebral infarction, Parkinson's disease and similar conditions). 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
Kinetic and quantitative analysis of [18F]AM-PBB3, and effective dose after injection.

Secondary

MeasureTime frame
Examination association with extent and distribution of [18F]AM-PBB3, [11C]PBB and [11C]PiB between dementia and healthy controls.

Countries

Japan

Contacts

Public ContactKazuko Suzuki

National Institute of Radiological Sciences Molecular Imaging Center

khsuzuki@nirs.go.jp043-206-3251

Outcome results

None listed

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