[18F]NAV4694 Imaging to Identify MCI Patients at Risk for Alzheimer's Dementia

DESCRIPTION provided by applicant Navidea Biopharmaceuticals is developing F NAV as a diagnostic imaging agent that can be used to visualize beta amyloid A plaques in the brains of living individuals Alzheimerandapos s disease is the leading cause of dementia All patients with dementia caused by Alzheimerandapos s disease have abundant A plaques in their brains There is a great need to develop better means to identify individuals who are at high risk of developing dementia caused by Alzheimerandapos s disease before their symptoms become severe This need has arisen from the extensive efforts of many companies to develop new and better therapies for this dreaded disease Ninety such candidate Alzheimerandapos s therapies are currently under investigation Due to the mechanisms of action of a large portion of these drug candidates they are likely to be most effective when given to patients before they have significant dementia The intent of these new therapies will be to prevent or delay the progression of their illnesses to frank dementia The problem addressed by this proposal is how to best indentify these patients A plaques begin to appear in the brains of Alzheimerandapos s patients many years before they develop dementia We recognize as others many individuals with A plaques never develop dementia However A plaques are indicative of Alzheimerandapos s pathology and once a patient with A plaques begins to experience cognitive decline they are at high risk of progression to Alzheimerandapos s dementia When people with Alzheimerandapos s pathology i e A plaques first experience cognitive symptoms their symptoms are minimal Such people are said to have Mild Cognitive Impairment MCI However MCI can have many causes besides Alzheimerandapos s pathology Patients with MCI and the underlying pathology associated with Alzheimerandapos s would be candidates for treatment with the new Alzheimerandapos s disease modifying therapies currently under development while MCI patients with other pathologies would not In the proposed study patients with MCI will be imaged with F NAV using positron emission tomography PET to identify those individuals with A plaques in their brains All participants in the study will then be followed for at least months to determine which individuals progress to frank Alzheimerandapos s dementia It is expected that all participants that progress to frank Alzheimerandapos s dementia will have had evidence of A plaques that were visualized by F NAV while none of the participants lacking A plaques will have progressed to defined Alzheimerandapos s dementia Thereby evidence will have been obtained indicating that F NAV imaging could be used to identify the portion of all MCI patients that is at high risk for developing Alzheimerandapos s dementia Other firms are also developing A imaging agents however Navidea Biopharmaceuticals believes based on its recent clinical data directly contrasting F NAV vs F PIB that the superior performance characteristics of F NAV compared to its competitors will make it the preferred imaging agent for this application PUBLIC HEALTH RELEVANCE Alzheimerandapos s disease is an emerging epidemic in the US on a trajectory that if not curtailed will result in catastrophic increases in the number of people afflicted by dementia caused by this disease with an associated enormous increase in healthcare costs To avert this catastrophe new medications are already in development that if delivered to individuals at high risk for developing Alzheimerandapos s dementia can potentially prevent or delay the onset of Alzheimerandapos s dementia Navidea Biopharmaceuticals is requesting an SBIR grant to support efforts needed to commercialize F NAV as a diagnostic imaging agent that can assist physicians in identifying those individuals with mild cognitive impairment who are at greatest risk of progressing to Alzheimerandapos s dementia