Regulatory Approval of the OLFACT Test Battery

DESCRIPTION provided by applicant Although there are numerous scientific studies in the literature that show impairments in olfaction often occur early in the onset of Alzheimerandapos s Disease AD there is still concern pertaining to the specificity of measures of olfactory dysfunction when used as a predictor of AD For this and other reasons there is no test based upon measures of olfactory function that has been cleared by the FDA for use as a screen for the disease Consequently the major goal of this application is comprised of two different but closely related components validating the OLFACT tm Test Battery TB as a sensitive early predictor of AD and gaining FDA clearance of the OLFACT tm TB for use as a screening test in the assessment of AD To achieve this goal two specific projects are proposed The first is to demonstrate that impairments in olfactory function predict onset of AD To accomplish this in Phase I an automated test of olfactory function the OLFACT tm TB will be developed and used to measure olfactory function in participants of the Rush University Medical Center Memory and Aging Project a longitudinal cohort in which over participants are being evaluated for the development of MCI and AD Participants in these studies are extensively evaluated on an annual basis with batteries of neuropsychological tests neurological exams and clinical assessments Using logistic regression this comprehensive data set will be used in conjunction with neuropathologic data the andquot gold standardandquot for diagnosing AD to be collected during Phase II to determine the predictive utility of olfactory function as a screening test for AD The exhaustive nature of this data set will allow other causes of olfactory dysfunction as well as other cause of dementia to be documented and controlled for Also in Phase II in a second project at Massachusetts General Hospital approximately subjects will be recruited who have already been extensively evaluated for AD and in addition many have also received both volumetric MRIandapos s and amyloid PET These subjects will be administered the OLFACT tm TB during the course of the project to evaluate how well these other biomarkers compare to measures of olfactory function as a predictor of AD These combined data sets will form the basis of the second component a Premarket Approval PMA application to the FDA to obtain clearance for the OLFACT tm TB as a screening test for AD The availability of a FDA cleared test which was valid noninvasive inexpensive and an early predictor of AD would be of immense value not only in the diagnosis of AD in preclinical stages but also as a way to reduce costs in the recruitment of affected individuals for clinical trials The test could also prove to e useful in the assessment of the efficacy of potential drug therapies or other therapeutic interventions when measured over time PUBLIC HEALTH RELEVANCE Alzheimerandapos s disease AD is the leading cause of dementia in old age with to million Americans currently affected and sharp increases in those numbers are expected by mid century with the aging of the U S population Impairments in the sense of smell are one of the earliest indicators associated with the development of AD This proposal will measure olfactory function in two longitudinal studies of AD in order to establish the relationship between loss of sense of smell and AD determine the relationship between measures of olfactory functions and other biomarkers and seek FDA clearance of the OLFACT tm Test Battery for use as a screening test in the assessment of AD This would be the first olfactory test cleared by the FDA for this purpose and would provide both clinicians and researchers a powerful tool in the fight against this disease