National Institute on Aging seed funding enables Alzheimer's disease startups to reach key value inflection points.

INTRODUCTION: The National Institute on Aging (NIA) provides funding to academic researchers and small businesses working in the Alzheimer's Disease (AD) and AD-related dementia (ADRD) fields to help commercialize their products. The NIA uses Small Business Innovation Research (SBIR) awards to bridge the funding gap in the diagnostic, therapeutic, and care interventions areas, enabling startups to reach key value inflection points to achieve scientific milestones. METHODS: Only publicly available information is reported. The National Institutes of Health Report Portfolio Online Reporting Tool database and the commercial database Global Data, were used to track the progress of companies that received SBIR or Small Business Technology Transfer (STTR) funding from the NIA. RESULTS: Since 2008, the NIA has awarded $280 million-including $207 million from fiscal year (FY) 2015 to FY 2019-in new small business program awards for AD/ADRD research. DISCUSSION: NIA seed capital and mentoring programs are critical resources to help small businesses reach key value inflection points and advance their research from concept to commercialization.

Attracting New Investigators to Alzheimer's Disease Research: Outcomes of Increased Funding and Outreach.

Since 2015, the National Institute on Aging (NIA), National Institutes of Health (NIH), has experienced significant increases in funding for Alzheimer's disease and Alzheimer's disease-related dementias (AD/ADRD). This analysis assesses the impact of these funds on expanding the AD/ADRD workforce. NIA administered 860 awards to 695 AD/ADRD R01 awardees during fiscal year 2015-2018. Twenty-nine percent of awardees were new or early-stage investigators, while 38% were new to the AD/ADRD research field (NTF). Among these NTFs, 59% were established investigators, that is, experts with NIH funding in another discipline but new to AD/ADRD research. Awards were further analyzed to determine the focus of their research based on International Alzheimer's Disease Research Portfolio (IADRP) categories. Forty-six percent were focused on Molecular Pathogenesis and Physiology. Other IADRP categories, including Diagnosis, Assessment, and Disease Monitoring and Translational Research and Clinical Interventions, represented 5%-15% of awards. Significantly, NTF investigators received 50%, 42%, and 70% of the total grants awarded in Population Studies, Dementia Care, and Brain Aging, respectively, suggesting that NTF investigators are filling research gaps. While these results suggest that enhanced funding is associated with recruitment of new talent, opportunities for further growth remain, particularly related to care, caregiving, and health disparities.

Adequacy of Inclusion of Older Adults in NIH-Funded Phase III Clinical Trials.

In the United States, the population aged 65 and older is rapidly growing, and this group uses more healthcare resources and has unique healthcare needs that do not exist in younger populations. However, it was reported that older adults are excluded or underrepresented in clinical trials for several diseases. We examined phase III clinical trials funded by the National Institutes of Health found in www.clinicaltrials.gov from 1965 to 2015 that addressed top causes for hospitalization and/or disability-adjusted life years in older adults: congestive heart failure (n = 45), cardiac dysrhythmias (n = 24), coronary atherosclerosis (n = 106), heart attack (n = 76), stroke (n = 113), chronic obstructive pulmonary disease (n = 14), pneumonia (n = 48), lung cancer (n = 117), prostate cancer (n = 65), and osteoarthritis (n = 15). We then analyzed the representation of older adults in these studies. We found that 33% of studies had arbitrary upper age limits, and 67% of studies reported mean and/or median ages that skewed younger than expected for the disease or condition of interest. Beyond explicit exclusion by age, older adults were often implicitly excluded based on various comorbid conditions such as polypharmacy/concomitant medication (37%) or cardiac issues (30%). We conclude that outcomes of these trials may not be fully generalizable to the general population of older adults. J Am Geriatr Soc 67:218-222, 2019.