NEUROCOG TRIALS — Department of Health and Human Services SBIR Phase II: NIA

Description

DESCRIPTION provided by applicant Aging populations have become a key target for therapeutics developers particularly for indications impacting cognitive function Conditions such as Alzheimerandapos s disease and vascular dementia affect the quality of life of aging Americans largely due to their impact on cognitive function with insufficient therapeutic options Recent reports indicate that early identification of at risk individuals may help to slow progression and onset of cognitive decline Thus new cognitive tests capable of screening patients for mild or moderate cognitive decline associated with the earliest stages of neurodegenerative disease are urgently needed Tests such as the ADAS Cog Alzheimerandapos s Disease Assessment Scale Cognitive subscale lack sensitivity to milder forms of cognitive impairment and are cumbersome and time consuming to administer and score Effective screening tests for cognitive impairment must be brief simple to administer and automatically scored These tests must be tailored toward aging populations and demonstrate sensitivity to mild cognitive decline In order to allow meaningful interpretation of individualandapos s performance well powered demographically targeted normative studies are essential andquot Pen and paperandquot testing remains largely the standard for the assessment of cognitive decline Some recently developed computerized tests have demonstrated improvement in ease of use data reliability and cost effectiveness in most demographic groups In the aging population however performance on computerized tests is often poorly correlated with performance on pen and paper tests calling into question the validity of data collected with computerized tests in this population The Brief Assessment of Cognition BAC test battery developed by NeuroCog Trials has been employed in a range of studies associated with cognitive impairment and has recently been adapted as a computerized test the BAC App administered via iPad r In our company funded andquot Phase I Report andquot we provide details regarding the development of the BAC App as well as data from our validation study showing a strong correlation between performance on the pen and paper BAC and performance on the BAC App in aging adults These data are extremely encouraging and we propose to expand the number of tests included in the BAC App This would allow for greater sensitivity to deficits in episodic memory and spatial working memory which are among the earliest signs of cognitive decline particularly in Alzheimerandapos s Our Phase II program will focus on integrating these new tests into the BAC App conducting a well powered normative data study in aging adults in collaboration with Dr Kathleen Welsh Bohmer Duke University and determining the ability of the BAC App to discern healthy subjects from those experiencing cognitive decline Successful completion of the Phase II program will enable NeuroCog Trials to offer the BAC App in cognitive decline studies specific to aging populations a need reflected in both the literature and recent feedback from NeuroCogandapos s customers PUBLIC HEALTH RELEVANCE As the United States population ages more therapies are being developed and marketed to address cognitive decline particularly for neurodegenerative indications such as Alzheimerandapos s disease A key element to the development of these therapies is reliable assessment of cognition in aging adults Computerizing cognitive tests represents an excellent means to improve cost effectiveness and ease of use However several studies indicate that aging adultsandapos performance on computerized cognitive tests may not always correlate well with their performance on pen and paper cognitive tests To address this urgent and unmet need NeuroCog Trials proposes the tailoring of the Brief Assessment of Cognition Application BAC App a neurocognitive assessment administered via iPad r to aging adult populations for assessment of cognitive deficits