NAV4-04 is a Phase 2b, open-label, multi-center, non-randomized, PET imaging study to assess the safety and efficacy of NAV4694 in subjects diagnosed with MCI to investigate whether NAV4694 PET scan findings have the ability to distinguish subjects with MCI who progress to AD from those who do not. In conjunction with neuro-cognitive testing examinations, subjects are planned to receive three injections of the investigational, diagnostic agent during a 36 month period: at baseline, 18 months and 36 months. The study will determine the specificity of NAV4694 PET imaging to identify the portion of all MCI patients that are at high risk of developing AD dementia and will estimate the rate of progression of the MCI patients with beta-amyloid deposits to AD dementia. Information on the protocol and enrolling sites for this study (NAV4-04) can be found at:

http://www.clinicaltrials.gov/ct2/show/NCT01812213?term=Navidea&rank=4.


About NAV4694

NAV4694 is a Fluorine-18 labeled precision radiopharmaceutical candidate intended for use in Positron Emission Tomography (PET) imaging and evaluation of patients with signs or symptoms of cognitive impairment such as Alzheimer's disease (AD). NAV4694 binds to beta-amyloid deposits in the brain that can then be imaged in scans. Beta-amyloid plaque pathology is widely used in the diagnosis of AD. The ability of NAV4694 imaging to display amyloid plaque pathology may enable earlier identification of AD and improve monitoring of disease progression and interpretation of brain scan images. Navidea has an ongoing NAV4694 Phase 2b trial in Mild Cognitive Impairment and a Phase 3 program for NAV4694 in AD.

About Mild Cognitive Impairment

Mild cognitive impairment (MCI) is a condition in which people have memory or other thinking problems greater than normal for their age and education.1 People with mild cognitive impairment are at increased risk of progressing to dementia due to Alzheimer's disease (AD) or other causes. New therapies are on the horizon that offer the potential to modify the trajectory of AD. To be most effective, these new therapies will most likely need to be administered early in the progression of a patient's illness when their cognitive symptoms are least severe. Patients with MCI and the underlying pathology associated with AD would be candidates for treatment with these new AD therapies, while MCI patients with other pathologies would not. Imaging studies that can visualize beta-amyloid deposits in the brains of living patients will become a key component of the diagnostic protocol that identifies these patients which will enable the most effective use of these new therapies.

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