18F-PM-PBB3 PET Study in Tauopathy Including Alzheimer's Disease, Other Dementias and Normal Controls
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|ClinicalTrials.gov Identifier: NCT03625128|
Recruitment Status : Completed
First Posted : August 10, 2018
Last Update Posted : October 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease Cortical Basal Syndrome Frontotemporal Dementia Progressive Supranuclear Palsy Vascular Cognitive Impairment||Drug: F-18||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 0 Evaluation of Clinical and Neuroimage (18F-PM-PBB3 PET) Study in Tauopathy Including Alzheimer's Disease, Other Dementias and Normal Controls|
|Actual Study Start Date :||January 2, 2018|
|Actual Primary Completion Date :||August 3, 2018|
|Actual Study Completion Date :||December 3, 2018|
Experimental: F-18 PMPBB3
F-18 PMPBB3 imaging
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).
Other Name: F-18 PMPBB3
- The primary outcome measures are to evaluate the dosimetry of novel radiotracer 18F-PM-PBB3 in human. [ Time Frame: YEAR ONE ]Time-integrated activity in each organ will be calculated by trapezoidal integration of the first 45 min of the organ's time-activity curve, followed by a single-exponential fit to the remaining data points (based on the 4 whole-body images) extrapolate to infinity, all base on non-decay-corrected data.Residence times will be obtained by dividing the time-integrated activity by the injected amount of activity.
- Optimal scanning time for brain imaging using 18F-PM-PBB3 . [ Time Frame: YEAR ONE ]PET data will be acquired using SIMENS PET/CT or PET/MRI scanner with an axial field of view of 15.7cm. For PET/CT protocol, a 50-min dynamic brain PET scan (6x10s, 4x60s, 5x180s, 6x300s) will be started simultaneously with the injection of 10mCi of 18F-PM-PBB3 after a low-dose CT scan for patient positioning and attenuation correction.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03625128
|Chang Gung Memorial Hospital,Linkou|
|Taoyuan City, Guishan Dist, Taiwan, 333|
|Principal Investigator:||Chin-Chang Huang||Chang Gung Memorial Hospital|