SBIR-STTR Award

The Alzheimer's Association 2009 Alzheimer's Disease Facts and Figures report indicates that as many as 5.3 million Americans suffer from Alzheimer disease (AD), and it costs the country about $148 billion a year to provide care. AD triples healthcare costs for Americans who are 65 and older, and will have a devastating impact in the near future. It is expected that AD will affect as many as 16 million Americans by 2050 as the baby boomers reach the age at which they are most at risk. Because neuropathological changes related to AD may begin 20 to 30 years before the onset of clinical symptoms in individuals at great risk, the onset of AD is insidious and the boundaries between age-associated memory impairment and actual AD are blurred. It is of major challenge to develop new technologies for the early detection of AD in order to facilitate disease prevention, diagnosis, and effective treatment. The goal of this Small Business Innovation Research (SBIR) Program application is to develop an innovative imaging technology for the early detection of AD for the marketplace. In order to facilitate the translation of the fcMRI lab research into practical clinical applications, we will conduct the following specific aims in Phase I: Aim 1. Design and develop streamlined workflow and user-friendly prototype software UI (user interface) to demonstrate that users without extensive analysis expertise can utilize the GFC index analysis. Aim 2. Develop and validate (using existing datasets) a robust GFC index classifier that will individually discriminate cognitive normal (CN) subjects from Alzheimer's disease patients by using above mentioned prototype software. Aim 3. Conduct the technological research to determine how different magnetic field strengths (1.5 v.s. 3 Tesla) of MRI scanner systems will affect the GFC index. It is our goal to demonstrate that the GFC index can be used by majority of scanners. With this Phase I of the SBIR grant, we will demonstrate the feasibility of the proposed GFC index method in order to achieve satisfactory results in clinical settings. This will lay the foundation for the SBIR Phase II study. , ,

Public Health Relevance:
As many as 5.3 million Americans are suffering from Alzheimer disease (AD), and it costs the country around $148 billion a year to provide care. Because neuropathological changes related to AD may begin 20 to 30 years before the onset of clinical symptoms in individuals at great risk, the onset of AD is insidious and the boundaries between age-associated memory impairment and actual AD are blurred. The goal of this SBIR application is to develop an innovative imaging technology for the early detection of AD for the market place. We will design and develop streamlined workflow and user-friendly prototype software UI to provide a functional connectivity index. We will also develop and validate the index as a Classifier for individually discriminating between cognitive normal (CN) subjects and Alzheimer's disease patients. With this Phase I of SBIR grant, we will demonstrate the feasibility of the proposed functional connectivity index in order to facilitate disease prevention, diagnosis, and access effective treatments.

Thesaurus Terms:
Affect;Age;Age-Associated Cognitive Decline;Age-Associated Memory Impairment;Age-Related Cognitive Decline;Algorithms;Alzheimer;Alzheimer Disease;Alzheimer Sclerosis;Alzheimer Syndrome;Alzheimer's;Alzheimer's Disease;Alzheimers Dementia;Alzheimers Disease;Amentia;American;Ammon Horn;Au Element;Benign Senescent Forgetfulness;Brain;Brain Region;Caring;Clinical;Clinical Trials;Clinical Trials, Unspecified;Cognitive;Computer Programs;Computer Software;Cornu Ammonis;Country;Data Set;Dataset;Dementia;Dementia, Alzheimer Type;Dementia, Primary Senile Degenerative;Dementia, Senile;Detection;Development;Diagnosis;Disease;Disease Progression;Disorder;Doctor Of Philosophy;Early Diagnosis;Encephalon;Encephalons;Floor;Foundations;Frequencies (Time Pattern);Frequency;Future;Goals;Gold;Health Care Costs;Health Costs;Healthcare Costs;Hippocampal Formation;Hippocampus;Hippocampus (Brain);Image;Imaging Technology;Individual;Knowledge;Legal Patent;Mr Imaging;Mr Tomography;Mri;Magnetic Resonance Imaging;Magnetic Resonance Imaging Scan;Marketing;Medial;Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance;Memory Loss;Methods;Nmr Imaging;Nmr Tomography;Nervous System, Brain;Nuclear Magnetic Resonance Imaging;Onset Of Illness;Patents;Pathology;Patients;Pattern;Ph.D.;Phd;Phase;Primary Senile Degenerative Dementia;Process;Programs (Pt);Programs [publication Type];Reporting;Research;Rest;Risk;Sbir;Sbirs (R43/44);Sensitivity And Specificity;Series;Small Business Innovation Research;Small Business Innovation Research Grant;Software;Symptoms;System;System, Loinc Axis 4;Technology;Temporal Lobe;Translations;Treatment Efficacy;Wisconsin;Zeugmatography;Association Cortex;Base;Biomarker;Clinical Applicability;Clinical Application;Clinical Investigation;Computer Program/Software;Cost;Dementia Of The Alzheimer Type;Design;Designing;Develop Software;Developing Computer Software;Disease Diagnosis;Disease Onset;Disease Prevention;Disease/Disorder;Disorder Onset;Disorder Prevention;Early Detection;Effective Therapy;Hippocampal;Imaging;Indexing;Innovate;Innovation;Innovative;Magnetic Field;Medical Schools;New Technology;Phase 2 Study;Primary Degenerative Dementia;Programs;Prototype;Public Health Relevance;Senile Dementia Of The Alzheimer Type;Software Development;Temporal Cortex;Temporal Lobe/Cortex;Therapeutic Efficacy;Therapeutically Effective;Tool;User-Friendly

This application, "Imaging Software of Functional Connectivity MRI for Alzheimer's Disease", is written in response to (PA-11-134) "Lab to Marketplace: Tools for Brain and Behavioral Research (SBIR [R43/R44])". Alzheimer's disease (AD) is the most common form of dementia. However, developing drugs that effectively slow or alter the course of Alzheimer's disease has proven to be notoriously difficult. Academic and pharmaceutical scientists believe that a large part of the problem is that they are testing these drugs at the late stage in the progression of the disease, when damage to the brain is too severe to make intervention effective. Therefore, commercial AD biomarkers for early detection are of paramount importance in analyzing disease progression, yielding an accurate diagnosis and providing efficacy assessment following treatment in clinical trials and drug discovery. The goal of this SBIR Phase II application is to commercialize innovative neuroimaging technology tool, called Resting-state functional connectivity MRI (R-fcMRI), for the marketplace based on a decade of Alzheimer's research progress supported by the National Institues of Health in the laboratory of Shi-Jiang Li, Ph.D., and Alzheimer's Disease NeuroImaging Initiative (ADNI 2) program, and other neuroimaging labs. We will retrospectively and prospectively collect R-fcMRI imaging datasets from national and international multicenter studies to validate our commercial BS-GFC software product in order to provide a robust and reliable biomarker for assisting in the prediction of AD onset, diagnosis and assessment of treatment efficacy.

Public Health Relevance Statement:


Public Health Relevance:
Alzheimer's disease (AD) is the most common form of dementia. As many as 5.3 million Americans are suffering from Alzheimer disease (AD), and it costs the country around $148 billion a year to provide care. Today, it is the sixth leading cause of death and is expected to rise as the Baby Boomer generation ages. That figure is expected to balloon worldwide in the coming decades. However, it has been notoriously difficult to develop drugs that effectively slow or alter the course of Alzheimer's disease, because of the lack of commercial AD biomarkers that have the potential for early disease detection, accurate diagnosis and efficacy assessment in following treatment in clinical trials and drug discovery. The goal of this SBIR Phase II application is commercializing innovative neuroimaging technology tools, called Resting-state functional connectivity MRI (R-fcMRI), for the marketplace based on a decade of research progress in Alzheimer's disease research supported by the National Institue of Aging, a division of the National Institutes of Health, in the laboratory of Si-Jiang Li, Ph.D., and renewed Alzheimer's Disease NeuroImaging Initiative (ADNI 2) program and other neuroimaging labs. We will retrospectively and prospectively collect MRI/fcMRI imaging datasets from national and international multicenter studies to validate our commercial BS-GFC software product in order to provide a robust and reliable biomarker for assisting in the prediction of AD onset, diagnosis and assessment of treatment efficacy.

Project Terms:
Affect; Age; age related; Aging; Alleles; alzheimer disease detection; Alzheimer's Disease; Alzheimer's disease risk; American; Apolipoprotein E; base; Behavior; Behavioral Research; Biological Markers; Brain; brain cell; Brain Injuries; brain research; Caring; Cause of Death; Cessation of life; Clinical; Clinical Trials; clinically significant; Cognitive; cohort; Computer software; cost; Country; Data Set; Dementia; Detection; Diagnosis; Disease; Disease Progression; Doctor of Philosophy; drug discovery; drug testing; Early Diagnosis; effective intervention; Failure (biologic function); follow-up; Future; Generations; Genetic; Goals; Health; Hobbies; human subject; Image; Incidence; indexing; Individual; innovation; International; Laboratories; Life; Magnetic Resonance Imaging; Marketing; Memory; middle age; mild cognitive impairment; Multicenter Studies; Neurodegenerative Disorders; neuroimaging; Onset of illness; Persons; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Population; programs; Progress Reports; prototype; public health relevance; Reporting; Research; Research Personnel; Research Support; response; Rest; Scientist; Sensitivity and Specificity; Small Business Innovation Research Grant; social; software development; Solutions; Staging; Symptoms; Syndrome; Technology; Testing; Therapeutic; Thinking, function; Time; tool; Training; Treatment Efficacy; United States; United States National Institutes of Health; user-friendly; Validation; Work; Writing