This study is designed to obtain basic information on three PET imaging tracers developed to detect tau pathology in the brain. In this study, healthy control participants and participants with AD will be studied. Information collected will include brain and plasma kinetics, tissue distribution (in the brain), radiation dosimetry, and test-retest variability of the signal in the brain. The study will consist of Part 1, Part 2A, and Part 2B. During Part 1, imaging data will be assessed on an ongoing basis and based on data, one tracer will be prioritized over the other two tracers. The tracer selected will be further investigated in Part 2A and Part 2B.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
52
Radiolabeled low molecular weight compound, administered as single intravenous injection. The mass dose of \[11C\]RO6924963 injected will be \</=10 micrograms (mcg), injection volume \</=20 milliliters (mL). Target injected activity for \[11C\]RO6924963 will be 370-740 megabecquerel (MBq) \[10-20 millicurie (mCi)\].
Radiolabeled low molecular weight compound, administered as single intravenous injection. The mass dose of \[11C\]RO6931643 injected will be \</=10 mcg, injection volume \</=20 mL. Target injected activity for \[11C\]RO6931643 will be 370-740 MBq (10-20 mCi).
Radiolabeled low molecular weight compound, administered as single intravenous injection. The mass dose of \[18F\]RO6958948 injected will be \</=10 mcg, injection volume \</=20 mL. Target injected activity for \[18F\]RO6958948 will be 185-370 MBq (5-10 mCi). The final activity of \[18F\] RO6958948 will be adjusted up to 10 mCi per scan to allow sufficient counts by end of 200 minutes post radiotracer injection.
Parexel International; Harbor Hospital Center
Baltimore, Maryland, United States
Johns Hopkins Universtiy; Radiology Dept
Baltimore, Maryland, United States
Part 1: Standard Uptake Value (SUV), as Assessed by Tau PET Brain Scan
Time frame: Day 1 up to Day 14
Part 1: Standard Uptake Value Ratio (SUVR), as Assessed by Tau PET Brain Scan
Time frame: Day 1 up to Day 14
Part 1: SUV, as Assessed by Tau PET Scan of Whole Body
Time frame: Day 1 up to Day 14
Part 1: SUVR, as Assessed by Tau PET Scan of Whole Body
Time frame: Day 1 up to Day 14
Mean Residence Times for Each Organ, as Assessed by Tau PET Scan of Whole Body
Time frame: Day 1 up to Day 14
Part 1: Distribution Volume (VT), as Assessed by Tau PET Brain Scan
Time frame: Day 1 up to Day 14
Part 2A: Absolute Percentage Difference Between Test and Retest of SUVR
Time frame: Days 1, 28
Part 2A: Absolute Percentage Difference Between Test and Retest of VT
Time frame: Days 1, 28
Part 2B: Effective dose (ED), as Assessed by Whole Body PET Scan
Time frame: From the time of tracer injection on Day 1 up to 120 minutes post injection
Part 2A: Absolute Percentage Difference Between Test and Retest of SUV
Time frame: Days 1, 28
Percentage of Participants With Adverse Events (AEs)
Time frame: Part 1: Day 1 up to Day 28, Part 2a: Day 1 up to Day 42, Part 2b: Day 1 up to Day 15
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