New PET Imaging Agent Has Potential for Diagnosing Alzheimer’s

Navidea Biopharmaceuticals, Inc. (Dublin, OH, USA), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, reported that enrollment has commenced at two sites participating in its phase 2, open-label, safety and efficacy PET imaging study of [18F]NAV4694 for detection of cerebral ß-amyloid plaque in subjects diagnosed with probable AD. The study is designed to compare images from study participants with probable AD with similarly aged and young healthy volunteers (HV). Two trial sites are currently enrolling subjects: Molecular NeuroImaging, LLC (New Haven, CT, USA), which dosed the first patient in the study; and the Alzheimer’s Disease Center at Quincy Medical Center (Quincy, MA, USA).

“We are pleased to participate in this clinical study of NAV4694, which has the potential to help advance diagnostic accuracy in people with Alzheimer’s disease,” said Danna Jennings, MD, clinical research director, Molecular NeuroImaging, LLC. “NAV4694 appears to exhibit the strengths of 11C PIB [11C-labeled Pittsburgh compound-B] but given that the ligand is labeled with 18 F it offers flexibility and is more practical to use. The data at this point in the development suggest that NAV4694 shows favorable sensitivity, specificity, and decreased white-matter uptake that may enable earlier Alzheimer’s disease identification, better monitoring of disease progression, and easier scan interpretation.”

“In addition to safety and efficacy endpoints, this clinical trial will allow us to evaluate NAV4694 to determine the correlation of the clinical diagnosis with the ß-amyloid plaque uptake in PET images of subjects diagnosed with probable AD,” commented Frederick Cope, PhD, FACN, CNS, Navidea’s senior vice president, pharmaceutical research and clinical development. “Our ultimate goal is to provide an improved diagnostic tool with outstanding performance characteristics for physicians to aid in the diagnosis of AD, a disease expected to impact as many as 16 million Americans by 2050.”

This is a phase 2, open-label, multiple center, nonrandomized single dose, PET imaging study to assess the safety and efficacy of [18F]NAV4694 in detecting ß-amyloid plaque in the brain in subjects with probable Alzheimer’s disease compared with similarly aged and young healthy volunteers. In addition to safety and efficacy goals, this study also will measure the correlation between neuro-psychiatric test findings with the amount of ß-amyloid determined by the NAV4694 imaging.

NAV4694 is a fluorine-18 labeled precision radiopharmaceutical candidate intended for use in PET imaging and evaluation of patients with signs or symptoms of cognitive impairment such as AD. NAV4694 binds to ß-amyloid deposits in the brain that can then be imaged in scans. Amyloid plaque pathology is typically used in the diagnosis of AD so the ability of NAV4694 combined with amyloid plaque pathology may enable earlier identification of AD and improve monitoring of disease progression and interpretation of brain scan images. Navidea plans for a phase 3 trial of NAV4694 to begin in early 2013.

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