XingImaging, LLC
This is a single-center, open-label clinical study designed to evaluate alpha-synuclein (ASYN) deposition in the brain of participants with Parkinson's disease (PD), as compared with healthy elderly (HE) participants. Up to 18 participants (12 PD, 6 HE) are planned to be enrolled. Each participant will receive a single IV injection of \[¹⁸F\]MK-0947 as part of Part 1A followed by PET imaging using the Investigational United Imaging NeuroEXPLORER(NX) camera or the Siemens Biograph mCT camera. If enrolled in Part 1B a second injections and PET scan may be conducted in participants with PD and HE from Part 1A.
This is a single-center, open-label clinical study to evaluate the brain uptake and pharmacokinetics of \[¹⁸F\]MK-0947 in participants with PD, compare to HE participants, and demonstrate the utility of \[18F\]MK-0947 to quantify alpha synuclein pathology in participants with PD. Part 1A will enroll participants with PD (up to 12) and HE (up to 6) to evaluate \[¹⁸F\]MK-0947 in the brain of participants with PD using two different PET scanners: either standard resolution (\~5 mm) Siemens Biograph mCT PET scanner (Std PET), or an advanced high resolution (\~1.5 mm) Investigational United Imagin…
Inclusion Criteria: * All Participants (PD, HE) 1. Must voluntarily sign and date each informed consent, approved by the Research Ethics Committee (REC) prior to the initiation of screening or study-specific procedures. 2. For women of childbearing potential, agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs for 90 days following the last PET scan in each study period, as defined below: 3. A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal s…
Participants enrolled in the study will receive up to two single IV injections of \[¹⁸F\]MK-0947 followed by dynamic PET imaging using the United Imaging NeuroEXPLORER (NX) brain PET scanner, the Siemens Biograph mCT brain PET scanner, or both.
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