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Phase 1 and Phase 2 Clinical Trials for the Evaluation of Pharmacokinetics, Safety, and Efficacy of SNUBH-NM-333(18F) in Alzheimer's Disease Patients and Healthy Volunteers.
To evaluate pharmacokinetics, safety and efficacy of SNUBH-NM-333(18F), a new diagnostic radiopharmaceutical for PET imaging of amyloid plaques, in Alzheimer's disease patients and healthy volunteers.
The investigators will perform whole-body and brain kinetic modeling of SNUBH-NM-333(18F) and optimize the image acquisition procedure. Five young healthy subjects will be participated in Whole-body positron emission tomography /computed tomographic (PET/CT) scans from the midfemoral position to the head after approximately 5-10 mCi of SNUBH-NM-333(18F) injection. For brain PET/CT amyloid imaging, another five young healthy subjects will be scanned dynamically during windows of 0-180 min after injection of SNUBH-NM-333(18F), with arterial sampling. The investigators will compare different analysis methods of compartmental modeling and standardized uptake value ratios and determine the optimal acquisition window. And then 10 AD patients and 10 elderly healthy controls will also be participated in brain amyloid imaging to compare SNUBH-NM-333(18F) brain retention in AD patients versus healthy elderly.
Age
20 - 80 years
Sex
ALL
Healthy Volunteers
Yes
Seoul National University Hospital
Seoul, South Korea
Start Date
December 1, 2010
Primary Completion Date
May 1, 2011
Completion Date
December 1, 2012
Last Updated
May 29, 2014
30
ACTUAL participants
SNUBH-NM-333(18F)
RADIATION
Lead Sponsor
Seoul National University Hospital
NCT04123314
NCT07178210
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