Phase I Amount
$1,251,954
With the aging of the population, the risk for age-related conditions such as Alzheimer's disease(AD) and its common precursor, MCI, is increasing. However, studies targeting prevention of MCI and AD have commonly failed and part of the reason may be failures in selection of a population that is still at risk and has not yet developed fully syndromal MCI. This project leverages our experience with novel semantic interference paradigms and proposes to develop a widely accessible version of the Loewenstein-Acevedo Scales for Semantic Interference and Learning (LASSI-L). As noted in the body of the application, the LASSI-L has shown significant promise for the early detection of pre-MCI, in both national and international studies including identification of individuals with evidence of amyloid deposition in the absence of detectable cognitive impairments with standard neuropsychological measures. A computerized version of the LASSI, the LASSI- Brief Computerized (LASSI-BC) version has been developed and validated on a preliminary basis in our NIH funded studies but requires significant refinement to make it applicable for commercial use. The goal of this phase II SBIR is to develop the next generation of semantic interference measures (LASSI-D), by making it feasible to remotely deliver and score, for both large-scale clinical trials screening and clinical use. Given the millions of individuals in the US and the rest of the world who are at risk for development of dementia, early intervention is critical and the availability of such as assessment strategy would broadly increase access to early screening and detection. The proposed Phase II SBIR is responsive to PAS-19-316, SBIR Phase II. In specific, this application is directly focused on development of: "Sensitive, specific, and standardized tests for diagnostic screening of mild cognitive impairment (MCI) and dementia, including the development of new, cost- effective, minimally-invasive biomarkers that could be used for screening in the general population and in community settings". In this study we will evaluate whether the LASSI-D is also sensitive to the earliest phase of MCI as well as being related to blood-based amyloid and tau biomarkers. This system will be designed to be self- administered and hence to be widely useful for large- scale clinical trial screening in the general population and clinical use in community settings.Our company is conducting a phase II SBIR focused on a self-administered system for the treatment of functional deficits in MCI and the cloud-based platform for delivery ofthe functional skills assessment and training program (FUNSAT) will be used for the development of the LASSI-D. Our long-term goal is to develop a commercially successful suite of products that can help identify risk for, prevent, and treat cognitive and functional declines and maintain the cognitive health and functional independence of older adults. Commercialization efforts have begun for both FUNSAT and LASSI-L and we have commitments from several large-scale potential customers.
Public Health Relevance Statement: PROJECT NARRATIVE The population is aging and cognitive impairments, which adversely impact abilities important to everyday functioning and threaten independence, are common among older adults. This Phase II SBIR will develop and validate a web-based fully automated computerized assessment system focusing on detection of mild cognitive impairment at its earliest stages, which will be suitable to be self- administered under the supervision of a health care professional or clinical trials research staff for. This will allow for both broad accessibility of clinically focused assessment to older adult populations and provide rapid and valid screening for entry into prevention trials targeting Alzheimer's Disease, which will likely be continuing to increase as efforts are undertaken to prevent Alzheimer's Disease.
Project Terms: Elderly; advanced age; elders; geriatric; late life; later life; older adult; older person; senior citizen; Aging; Alzheimer's Disease; AD dementia; Alzheimer; Alzheimer Type Dementia; Alzheimer disease; Alzheimer sclerosis; Alzheimer syndrome; Alzheimer's; Alzheimer's disease dementia; Alzheimers Dementia; Alzheimers disease; Primary Senile Degenerative Dementia; dementia of the Alzheimer type; primary degenerative dementia; senile dementia of the Alzheimer type; Amyloid; Amyloid Substance; Blood; Blood Reticuloendothelial System; Brain; Brain Nervous System; Encephalon; Child; 0-11 years old; Child Youth; Children (0-21); youngster; Clinical Research; Clinical Study; Clinical Trials; Cognition; Communities; Cues; Amyloid deposition; Elements; Exhibits; Goals; Gold; Health; Learning; Memory; Methods; middle age; mid life; mid-life; middle aged; midlife; Persons; NIH; National Institutes of Health; United States National Institutes of Health; Neuropsychologic Tests; Neuropsychological Tests; Neuropsychologies; neuropsychologic; Neuropsychology; On-Line Systems; online computer; web based; Online Systems; Paper; Parents; Patients; PET; PET Scan; PET imaging; PETSCAN; PETT; Positron Emission Tomography Medical Imaging; Positron Emission Tomography Scan; Rad.-PET; positron emission tomographic (PET) imaging; positron emission tomographic imaging; positron emitting tomography; Positron-Emission Tomography; Psychometrics; Research; Investigators; Researchers; Research Personnel; Rest; Risk; Sampling Studies; Self-Administered; Self Administration; Semantics; Software; Computer software; Specificity; Standardization; Supervision; Syndrome; Testing; Training Programs; Universities; Work; Measures; tau Proteins; MT-bound tau; microtubule bound tau; microtubule-bound tau; tau; tau factor; Ï Proteins; Businesses; Diagnostic tests; base; Clinical; Phase; Evaluation; Failure; Memory Deficit; memory dysfunction; Memory impairment; Individual; Early Intervention; Funding; p-tau; p-Ï; phospho-tau; phospho-Ï; phosphorylated tau; tau-1; Multiculturalism; Cultural Diversity; Atrophy; Atrophic; Cognitive Disturbance; Cognitive Impairment; Cognitive decline; Cognitive function abnormal; Disturbance in cognition; cognitive dysfunction; cognitive loss; Impaired cognition; instrument; System; late onset alzheimer; Late Onset Alzheimer Disease; Amentia; Dementia; early detection; Early Diagnosis; experience; Performance; skills; cognitive defects; Cognitive deficits; novel; Participant; validation studies; General Public; General Population; Prevention; Sampling; Property; neuropathology; Brain region; preventing; prevent; Voice Recognition Software; Speech Recognition Software; Data; Detection; International; PSI; Protein Structure Initiative; Cognitive; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Update; Development; developmental; Health Professional; Health Care Professional; Healthcare professional; age related; age dependent; functional decline; decline in function; decline in functional status; functional status decline; digital; computerized; design; designing; next generation; cost effective; Population; Cognitive aging; cognitive neuroscience; user centered design; usability; Alzheimer disease prevention; AD prevention; Alzheimer prevention; comparative; commercialization; aging population; aged population; population aging; community setting; minimally invasive; Biological Markers; bio-markers; biologic marker; biomarker; screening; mild cognitive impairment; mild cognitive disorder; cloud based; cognitive testing; cognitive assessment; Prevention trial; diagnostic screening; blood-based biomarker; blood-based marker; amnestic mild cognitive impairment; early screening; functional independence; Alzheimer's disease biomarker; Alzheimer's biomarker; Alzheimer's disease biological marker; Alzheimer's biological marker; Amyloid beta-42; A ß-42; A ß42; A-beta 42; A-beta42; Abeta-42; Abeta42; Amyloid beta42; Amyloid ß-42; Amyloid ß42; Amyloidß-42; Amyloidß42; Aß-42; Aß42; prodromal Alzheimer's disease; prodromal AD; prodromal Alzheimer's; ß-amyloid burden; Aß burden; a-beta burden; abeta burden; amyloid burden; beta amyloid burden; ßamyloid burden; remote delivery; delivered remotely
