Brain Biosciences, Inc. — Department of Health and Human Services SBIR Phase I: DESCRIPTION (provided by applicant): Neurodegenerative diseases, such as Alzheimer and oth

Description

DESCRIPTION (provided by applicant): Neurodegenerative diseases, such as Alzheimer and other dementias, present significant societal and economic burden. The number of patients suffering from these disorders grows rapidly owing to the aging of the world population. Alzheimer's Association projects that the number of Americans living with Alzheimer's disease (AD) will increase from 5.4M today to 16 M in 2050. Management and treatment of brain disorders is a critical task facing the healthcare innovation system; continuing progress in this field will depend on early, high-confidence diagnosis. Amyloid imaging agents, the new promising class of Positron Emission Tomography (PET) radiopharmaceuticals, enable diagnosis of Alzheimer's pathology at the early stagesof disease. Brain Biosciences seeks to make neurological PET imaging affordable and widely available both in the clinic and in the research laboratory. To achieve this goal we aim to develop, validate, and obtain 510(k) FDA clearance for CerePET , a compact, portable, high-performance, and cost- effective, PET scanner for brain imaging. This innovative device is designed to achieve high resolution at a fraction of the cost of currently marketed whole body PET systems. CerePET applications include: (i) evaluation of amyloid burden in patients with suspected Alzheimer disease, mild cognitive impairment, and other neurodegenerative disorders, (ii) multicenter clinical trials of CNS-targeted pharmaceuticals using PET scan as a biomarker, (iii) clinical neuroscience research. During this Fast-track SBIR project, CerePET will be rigorously validated using a set of internationally recognized tests. CerePET imaging performance will be characterized per NEMA NU2-2007; the scanner will be used in a clinical study comparing amyloid burden in patients with Alzheimer's disease and healthy controls. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: This application proposes to develop small-footprint, high performance Positron Emission Tomography (PET) scanneroptimized for brain imaging. This device will lower the cost and increase availability of neurological PET examinations both in the clinical and research settings.