SBIR-STTR Award

Gaitiq: Establishing a Digital Biomarker of Preclinical Alzheimer's Disease
Award last edited on: 5/26/2022

Sponsored Program
SBIR
Awarding Agency
NIH : NIA
Total Award Amount
$2,952,894
Award Phase
2
Solicitation Topic Code
NIA
Principal Investigator
Richard J Morris

Company Information

GaitIQ LLC

100 East Houston Street 8th Floor
San Antonio, TX 78205
   (512) 466-2211
   N/A
   www.gaitiq.com
Location: Single
Congr. District: 35
County: Bexar

Phase I

Contract Number: 1R43AG060855-01
Start Date: 9/15/2018    Completed: 2/28/2019
Phase I year
2018
Phase I Amount
$459,656
Alzheimer's disease (AD) is the most common cause of dementia and is the third leading cause of death in older adults in the US. Over 4.7 million Americans aged 65 and older live with AD and this number is expected to climb to nearly 14 million by 2050. However, fewer than 50% of individuals with AD have been diagnosed. and patients who have the condition are unlikely to receive a full diagnostic workup to identify the cause(s) of their impairment. Detection of functional markers is an essential first step toward prevention and early diagnosis of MCI, Alzheimer's Disease (AD) and related dementias. Recently, several highly regarded clinical aging studies have demonstrated that subtle changes in gait are early, sensitive and specific, noninvasive risk markers for both cognitive decline and fall risk. The majority of these clinical investigations have used an instrumented mat system (e.g. the GaitRite system) that measures spatio-temporal gait parameters from footfalls. Although the literature is consistent about the potential for spatio-temporal footfall-based metrics as a predictor of MCI and dementia, the technology industry has not delivered an accurate yet affordable solution appropriate for widespread use in a primary care setting. A new and novel approach is required to transfer the significant clinical research findings to clinical practice. The goal of this SBIR is to create an accurate, low cost, simple-to-use primary care clinical screening tool for MCI and dementia and a risk assessment and stratification tool for older adults with normal cognition. This will be accomplished by commercializing recent research in novel software-based deep learning marker-less motion capture and advanced kinematic analysis methods. A secure mobile application and cloud-based big data analytics platform delivers this Software-as-a Service to providers with the low cost and ease-of use required to accelerate adoption. This new approach applies deep learning technology to measure footfall-based gait parameters. It can replicate the level of precision and accuracy of expensive (>$35,000) and space-consuming electronic mats used in previous research studies. In addition, our work will significantly advance the research field by simultaneously measuring, from the same video stream, accurate 3D joint angles, which have recently been shown to be even more specific markers of neurodegeneration compared to footfall parameters. Long Term Goal: All patients will routinely have equal access to advanced gait analytics in primary care practices. By providing a consistent methodology, including integration in the Medicare Annual Wellness Visit, very large population data will be collected and analyzed to provide new insights into early stages of dementia, discover new functional markers from 3D kinematics, improve diagnostic assessments, and identify new preventive strategies for cognitive decline and risk of falls.

Public Health Relevance Statement:
Alzheimer’s disease continues to be difficult to predict and diagnose in clinical settings and while advanced imaging, neuropsychological testing and CSF measures may be available to specialized clinician investigators involved in research and clinical trials, these are not accessible to general health care providers. Research has clearly demonstrated that quantitative measures of gait, not routinely assessed in a clinic, can contribute substantially to identifying older adults at high risk for transitioning to dementia. Availability of the GaitIQ motion capture system at a primary care or geriatric clinic will aid the early identification of older adults who need further clinical evaluation, supportive treatment and rehabilitative care.

Project Terms:
Adoption; Aging; Algorithms; Alzheimer's Disease; American; base; Big Data; Biological Markers; care providers; Cause of Death; Cellular Phone; Clinic; Clinical; clinical care; clinical investigation; clinical practice; Clinical Research; Clinical Trials; cloud based; Cloud Computing; cloud platform; Cognition; cohort; commercial application; Computer software; cost; Data; Data Analytics; Data Collection; deep learning; Dementia; design; Detection; Development; Diagnosis; Diagnostic; Disease; Early Diagnosis; Early identification; Elderly; Electronic Health Record; Engineering; Environment; fall risk; Funding; Gait; gait examination; Goals; Gold; Health; health information technology; Health Personnel; High Performance Computing; high risk; human old age (65+); Image; Impaired cognition; Impairment; improved; Individual; Industry; innovation; insight; instrument; Joints; kinematics; Legal patent; Literature; Measurement; Measures; Medicare; Medicare/Medicaid; Methodology; Methods; mobile application; Modeling; Motion; Nerve Degeneration; Neuropsychological Tests; novel; novel strategies; Outcome; Patients; Performance; Phase; Population; Prevention; Prevention strategy; Preventive; Preventive Intervention; Preventive service; primary care setting; Primary Health Care; Provider; rehabilitative care; Research; research clinical testing; Research Institute; Research Personnel; research study; Risk Assessment; Risk Marker; Risk stratification; Running; Scientist; Screening procedure; Secure; Small Business Innovation Research Grant; software as a service; spatiotemporal; Stream; System; Tablets; technological innovation; Technology; Testing; Texas; Time; tool; Touch sensation; Universities; Visit; web services; Work

Phase II

Contract Number: 2R44AG060855-02
Start Date: 9/15/2018    Completed: 5/31/2022
Phase II year
2020
(last award dollars: 2021)
Phase II Amount
$2,493,238

Early detection of pre-clinical Alzheimer’s Disease (AD) during the long latent period prior to manifest dementia offers significant opportunities to advance the development of disease modifying interventions and effectively slow the disease’s progression. To achieve this objective, there is a critical need for new technologies that accelerate the development of biomarkers with high sensitivity for underlying AD pathology. A highly promising biomarker for preclinical AD is gait, as subtle gait changes have been correlated with elevated amyloid burden and cortical atrophy. While even simple measures of gait speed predict incident dementia in older adults, current research indicates that preclinical AD pathology is more precisely captured by a combination of 3D kinematic and spatio-temporal measures. A cost-effective mobile application that can be used in clinical trials and by healthcare personnel to capture these parameters efficiently, combined with a validated system to translate the measures to quantifiable AD risk in minutes, would result in a paradigm shift in availability of AD screening for at-risk individuals. GaitIQ™ is an innovative digital health startup company developing an online software-based product that employs computer vision and artificial intelligence (AI) to compute clinically accurate spatio-temporal and 3D kinematic data, from a simple video of a person walking. GaitIQTM collaborates with The Glenn Biggs Institute for Alzheimer’s and Neurodegenerative Diseases at UT Health San Antonio and Southwest Research Institute for this SBIR project. The expected outcome is that advanced kinematic/spatio-temporal measures of gait captured by the GaitIQTM system will reveal a sensitive and specific gait signature with high diagnostic accuracy for pre-clinical AD in a sample of Hispanic older adults. The project will develop and validate the capacity of GaitIQ™ to detect a digital gait biomarker signature that distinguishes between individuals with preclinical AD and controls. The final digital platform will be an easy-to-use, powerful tool to identify and monitor patients with pre-clinical AD using just an iPad/tablet to video their gait and submit it for analysis in the cloud by GaitIQTM sophisticated, proprietary analysis software.

Public Health Relevance Statement:
Changes in a patient’s walking gait can reveal important early signs of AD decades before cognitive symptoms are observed. GaitIQ™ is a San Antonio-based startup company focused on developing an early-stage digital health software technology that leverages novel machine vision, artificial intelligence (AI), and big data analytics. Our technology can detect subtle gait changes strongly correlated to increased risk for AD using just an iPad or tablet camera in the clinic.

Project Terms:
3-Dimensional; Adult; Advanced Development; Alzheimer disease screening; Alzheimer's Disease; Alzheimer's disease pathology; Alzheimer's disease risk; Amyloid; Artificial Intelligence; base; Big Data Methods; Biological Markers; biomarker development; Biomechanics; Brain imaging; care providers; cerebral atrophy; Clinic; Clinical; Clinical Research; Clinical Trials; cloud based; Cognitive; cognitive testing; Collaborations; Computer software; Computer Vision Systems; cost; cost effective; Data; deep learning; Dementia; Development; Devices; diagnostic accuracy; digital; Disease; Disease Progression; disorder control; Early Diagnosis; effectiveness validation; Elderly; follow-up; Gait; gait examination; Gait speed; Gold; Health; Health Personnel; Hispanics; human data; Impaired cognition; indexing; Individual; innovation; Institutes; Intervention; kinematics; Legal patent; Machine Learning; machine vision; Magnetic Resonance Imaging; Measures; Methods; mobile application; Motion; Neurobehavioral Manifestations; Neurodegenerative Disorders; new technology; novel; Outcome; Patient Monitoring; Patients; Persons; Phase; Population Heterogeneity; Positron-Emission Tomography; pre-clinical; predictive signature; Research; Research Institute; Risk; Risk stratification; Sampling; Screening procedure; Small Business Innovation Research Grant; spatiotemporal; Structure; System; Tablets; Technology; Testing; tool; Translating; United States National Institutes of Health; Walking; ?-amyloid burden