Nav4694

Published
Topics: MedicineNew Medicines

dm+d

Unassigned

New Medicines

Dementia; diagnosis

Information

New molecular entity
Navidea
Navidea

Development and Regulatory status

None
None
Phase III Clinical Trials
01. Jun 13: PIII study starts [1].
02. Mar 15: PIII study (NCT01886820) recruitment complete, study ongoing. The study is expected to complete in Jun 15 for primary outcomes [3].

Category

Fluorine-18 labeled radiopharmaceutical for use in Positron Emission Tomography (PET) imaging
Dementia; diagnosis
Intravenous

Trial or other data

01. Jun 13: NCT01886820 (NAV4-02) is a PIII Phase 3, open-label, multiple-center, non-randomized study to assess the safety and efficacy of NAV4694 PET imaging in detecting cerebral β-amyloid in subjects during life when directly compared to brain histopathological evaluation at autopsy. The trial will enroll up to 275 end-of-life individuals in two cohorts either, 1) subjects diagnosed with probable Alzheimer’s disease or other form of dementia, or, 2) non-demented volunteers. The efficacy of NAV4694 PET for the detection of β-amyloid will be determined by the sensitivity and specificity of visual interpretation of NAV4694 uptake in the PET scans by blinded readers vs the presence/absence of β-amyloid upon histopathological evaluation of the respective postmortem brain specimen in each subject. The first subject has been enrolled. Estimated primary completion date Jun 15 and final completion date Dec 16 [1]
02. Aug 13: The company has been awarded agrant from the National Institute On Aging in connection with the PIII clinical programme [2].