NEURACEQ

14.1 Evaluation of AD and Other Causes of Cognitive Decline The effectiveness of NEURACEQ was evaluated in two single-arm clinical studies (i.e., Studies 1 and 2) in subjects with a range of cognitive function, including some end-of-life subjects who had agreed to participate in a postmortem brain donation program as well as healthy subjects. Subjects underwent a NEURACEQ injection and scan. Images were interpreted using a clinically applicable binary image interpretation method (negative or positive) by independent readers blinded to all clinical information [see Dosage and Administration ( 2...

Most common adverse reactions (incidence ≥ 1%) were injection site pain, injection site erythema, and injection site irritation (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Lantheus Biosciences Ltd. at 1‑833-491-2524 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical tria...

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Risk of Image Misinterpretation and Other Errors: Image interpretation errors have been observed. (5.1) Radiation Risk: NEURACEQ contributes to a patient’s long-term cumulative radiation exposure. Ensure safe drug handling to protect patients and health care providers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration. (2.1, 2.2, 5.2) 5.1 Risk of Image Misinterpretation and Other Errors Errors may occur in...