Small Business Alzheimer's Disease Research (R41/R42)

Alzheimer’s disease (AD) is the leading cause of dementia in those over the age of 65 and as many as 5 million Americans age 65 and older have AD.  As the population ages the number of people age 65 and older with AD is projected to increase between two and three fold by 2050 without a cure or prevention of the disease. AD is one of the most persistent and devastating dementing disorders of old age, because it eventually leads to a complete loss of memory and of the ability to function independently.

Recent recommendations for AD research from the National Alzheimer’s Project Act, the 2012 Alzheimer’s Disease Research Summit, the  2013 Alzheimer’s Disease and Related Dementias Meeting, and the 2015 Alzheimer’s Disease Research Summit have recommended range of projects, including basic science on the biology, genetics of Alzheimer’s disease,  translational and clinical research development, testing of therapies to technological innovation which can improve  drug development, disease monitoring, diagnosis, assessment, and care. 

The purpose of this funding opportunity announcement (FOA) is to encourage Small Business Technology Transfer (STTR) applications from eligible small business concerns in the area of Alzheimer's disease.

Examples of research that might be supported by this FOA include, but are not limited to:

I. Division of Neuroscience AD SBIR-STTR Topics

1.  Development of sensitive, specific and standardized tests for diagnostic screening of MCI and dementia; for example, the development of new biomarkers that are minimally invasive, inexpensive, usable in community settings, and that could be used for screening a general population; Identifying new biomarkers that could serve as surrogate measures for disease progression in AD.  Improved instrumentation, imaging technology, related devices, and software packages for use in visualizing neural activity during cognitive, emotional, motor or sensory behavior in older adults.

2.  Discovery, development, and/or evaluation of drugs, biological or natural products, including central-nervous-system delivery systems to remediate age-related cognitive decline, and to treat the cognitive impairment and/or behavioral symptoms associated with MCI, AD, and other dementias of aging as well as to slow and/or reverse the course of the disease or to prevent it entirely through the application of systems biology and systems pharmacology approaches.

3. New technologies for in home use or for coordination or delivery of services to sustain in-home living for individuals with mild cognitive impairment or dementia. Examples include systems and devices to: evaluate, monitor and improve or adapt to changes in cognition; improve health service delivery; prolong functional independence ;support independent living and the conduct of everyday tasks at home; provide information to health care providers and family members with which to evaluate the need for intervention; and promote communication and interaction between individuals living in the community or in institutional settings and their health care providers, friends and family members.

4.  Development of manuals for existing evidence-based interventions that reduce the burden of caregiving for Alzheimer’s disease caregivers so that the manuals and training materials can be used by community-based agencies or health care organizations.

5.  Development of a tool that would allow Medicare Advantage managed care plans to accurately project future costs of caring for patients with dementia. Such a tool would be based on incidence and cost data and could be made adjustable for a health plan’s specific set of covered lives with its demographics and risk characteristics, etc. The product could be sold to Medicare Advantage-participating health plans.

6.  Testing in clinical trials of drug, nutritional, behavioral, cognitive or other types of interventions to remediate age-related cognitive decline, and to treat cognitive impairment and/or behavioral symptoms associated with MCI, AD, and other dementias of aging as well as to slow and/or reverse the course of disease or to prevent the onset of disease.

7.  Behavioral, environmental, pharmacological, & nutritional interventions to prevent and/or remediate brain biochemical and/or neurophysiological changes caused by neurodegenerative diseases, including age-related sensory dysfunction, motor dysfunction or age-related decrements in balance & postural control, gait performance, and mobility.

8.  Biosensors and prosthetic devices, technologies, and related software development to aid in the assessment, diagnosis, and remediation of age-related cognitive decline.

9.  Development of technology and analysis tools to examine, in a systematic way, genetic, epigenetic, transcriptomic, proteomic, metabolomic, and cell stress pathways in neurons and glia of the aging and AD brain. Development of molecular imaging technology and/or Chip-based technology for the in vitro and in vivo analysis of gene, epigenome, proteostasis, lipidomics and metabolomics and metabolic function in the normal aging brain and in AD.

10.  Improved technology for the analysis of structural and functional brain connectivity at the cell, neural circuitry and global network levels to define the trajectory of changes in brain structure and function in aging and AD. Development of technology, including non-invasive methods and novel probes, to monitor and manipulate the plasticity of neural circuits in the adult and aged nervous system. Development of novel markers of neural stem cell function (proliferation, migration, and differentiation) as well as methods to assess the integration and function of stem cells in the ageing and/or diseased nervous system.

II. Division of Behavioral and Social Research AD SBIR-STTR Topics

1. Development of machine learning tools and cognitive batteries which can be integrated to Electronic Medical Records (EMR) for diagnosis of mild cognitive impairment and AD.

2. Development of assistive robotics technology which can support a person to maintain or improve their independence, safety and wellbeing when diagnosed with AD and alleviate the burden of care.   This includes socially assistive robots which can support engagement, social participation and leisure of patients with MCI and AD.

3.  Development of cost effective technology which will create dementia-friendly cities and environments for individuals diagnosed with dementia.  This includes development of alarm technology and tracking and location monitoring devises which will alert caregivers and others if individuals with dementia are in unsafe areas while carrying daily activities such as walking.  Innovation is also encouraged for safer home environments, such as automatic shut-off valves for water (e.g. sink over flows when one forgets to turn-off faucet) and electricity and gas (e.g. forgetting to turn off stove).

4.  Development of comprehensive telecare system which can be used to support independence and personal safety of an individual with dementia.  The call is for comprehensive system, which will cover full extent of telecare and communication with caregiver, and healthcare providers.  The system will include community alarm, medication reminders, sensors for floods or extreme temperatures, absence from normal activities (e.g. sitting in a chair, going to bed), fall detection, unobtrusive sensors to monitor activities of daily living and vital signs which can be reported to the healthcare provider.    Development of such technology will allow for in-place monitoring of individuals at all stages of the dementia and integrating this information with other patient-relevant data in Electronic Medical records (EMR).

6. Recent literature review has shown disparities of care between racial and ethnic groups of individuals with Alzheimer's disease and related dementias.  Development of an educational training program for physicians, nursing assistants, home care aids and long-term services and support staff to provide “right care, delivered to the right patient, at the right time, in the right setting” is encouraged.

7.      Development of cognitive training applications/intervention to improve cognitive function in elderly.

• Rapidly develop novel, engaging computer-based cognitive training programs that are based on efficacious approaches and which use cognitive training to target a specific neural system/functional domain.
•      Augment existing computerized cognitive interventions to be individually tailored, engaging, adaptive, sufficiently challenging, and optimized for sustaining functional abilities and maximizing real world improvements.
• Interventions to remediate age-related cognitive decline, especially using technology platforms with wide acceptance among older adults.

See Section VIII. Other Information for award authorities and regulations.