18F-PM-PBB3 PET Study in Tauopathy Including Alzheimer's Disease, Other Dementias and Normal Controls
Status:
Completed
Trial end date:
2018-12-03
Target enrollment:
Participant gender:
Summary
This is an open-label study to evaluate the performance of a novel tau imaging ligand in up
to 36 subjects (12 AD, 3 FTD, 3 PSP, 3 CBS, 3 VCI and 12 HV). Subjects will be recruited from
the patient population and healthy volunteers of Taiwan residents. This study protocol
requires each subject to complete the following components: screening evaluation, brain MRI
and 18F-PM-PBB3 PET imaging up to two sessions. The screening procedures will include
neuropsychological assessments, vital signs, ECG, physical examinations and laboratory tests.
In addition, 18F-AV-45 PET imaging result will be as a part of inclusion criteria to confirm
presence of amyloid deposition in patients with clinically diagnosed probable AD or absence
of amyloid deposition in FTD, VCI and HV subjects. Furthermore, 18F-AV-133 PET imaging data
will also be as a part of inclusion criteria to confirm the diagnosis of PSP and CBS. All
subjects will complete clinical assessments and clinical safety tests to ensure the subject
is medically stable to complete the study protocol. The screening procedures will occur
within 30 days prior to 18F-PMPBB3 PET imaging.