Navidea Biopharmaceuticals Inc. announced the completion of a study of its novel radiopharmaceutical NAV4694 as a biomarker for visual detection and quantification of cerebral -amyloid in diagnosing Alzheimer's disease (AD). The study was designed and conducted by Navidea's partner, AstraZeneca, to assess the effects of various mass amounts of AZD4694 (NAV4694) on safety and the efficacy of Positron Emission Tomography (PET) scanning in subjects with AD and in healthy volunteers (HVs). Evaluations were completed on the effects of two mass doses of the radioligand on binding parameters and overall image quality.

These endpoints are typical and important requirements of drug registration dossiers filed with regulatory authorities for approval of diagnostic agents. The completed trial was an open-label, non-randomized, multi-center, PET study in a total of sixteen individuals (8 with mild to moderate AD and 8 elderly HVs) each imaged on two PET systems at Karolinska Institutet sites in Stockholm, Sweden. The study included elderly HVs to demonstrate that no unexpected tracer mass effects of AZD4694 (NAV4694) in subjects with low or no cerebral -amyloid occur; to compare imaging parameters from healthy, non-AD subjects with those from subjects with AD; and to extend the safety database.