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Clinical Trials: Aging
IRB No. 22-179J-1 (Dr. George Kuchel, PI): A deep longitudinal analysis of next generation influenza vaccines in older adults
This study is a collaboration between The Jackson Laboratory for Genomic Medicine (JAX) in Farmington, CT and UConn Health in Farmington, CT. All recruitment, enrollment, clinical data, and sample collection will occur at the UConn Center on Aging (COA), at UConn Health in Farmington, CT under the direction of Dr. George Kuchel, Professor of Medicine and Director of the UConn COA. Coded samples collected at Visits 1-17 will be securely transported to the Jackson Laboratory for Genomic Medicine (JAX), located on the UConn Health campus, for processing, storage, sequencing, and analysis. Dr. Duygu Ucar will oversee sample management and sample and data analysis per protocol. In this study, a total of sixty (60) healthy adults aged 65 years and older who have had no history of confirmed COVID-19 and have not received influenza vaccination for the approaching influenza season will be enrolled in the study and vaccinated with influenza vaccines approved by the U.S Food and Drug Administration (FDA) and recommended by the Centers for Disease Control and Prevention (CDC) for individuals ≥65 years. All participants receive influenza vaccine during the 2022-23, 2023-24, and 2024-25 influenza seasons. Participants will receive Fluzone® Quadrivalent High-Dose vaccine during the 2022-23 and 2024-25 flu seasons and FLUAD® Quadrivalent during the 2023-24 flu season. Blood samples will be collected from the participants at each of the seventeen study visits over three years. Nasal swab and stool samples will also be collected from participants at 7 time-points across the study period. The study is not designed to assess safety or tolerability of the influenza vaccines administered as part of this proposed study. By performing comprehensive profiling of their blood antibodies and immune cells over time, we will be able to associate specific age-related immune alterations with vaccine responder or non-responder status, thus allowing us to pinpoint biological pathways that can be targeted to enhance vaccine efficacy and that can also help us to progress towards developing a universal influenza vaccine.
IRB No. 23-089-2 (Dr. Cutter Lindbergh, PI): Computerized Cognitive Remediation of Long COVID Symptoms in Older Adults
Evidence is mounting that a significant minority of patients who develop coronavirus disease 2019 (COVID-19), especially older adults, show lingering neuropsychiatric symptoms including cognitive impairment, brain fog, and depression. These neuropsychiatric symptoms -- which are commonly referred to under the umbrella term "Long COVID" -- are debilitating and may last for months or even years after viral infection. There is a severe lack of evidence-based treatments. The purpose of the present study is to help address this public health crisis by determining whether computerized "brain-training" treatment has potential for improving thinking, mood, and other aspects of day-to-day functioning in older adults with Long COVID. There are two main aims of the present study. The first aim is to simply determine the "feasibility" of using brain-training treatment in older adults with Long COVID. This includes examining whether Long COVID patients are willing to engage in the treatment and whether they find the treatment acceptable and credible. The second aim is to gather preliminary data on whether the brain-training treatment appears to improve memory, thinking, mood, and other aspects of daily functioning in older adults with Long COVID.
IRB No. 23-134-2 (Dr. Julie Robison, PI): UConn Pepper Center (OAIC) Recruitment Volunteer Registry
Objective/Goals: The Research Volunteer Registry (RVR) is a mailing list that is used to invite and share opportunities to participate in future research studies and to community educational events the UConn Pepper Center will host.
IRB No. 24-127J-1 (Dr. George Kuchel, PI): Hematopoietic epigenetic memory as a driver of inflammaging
This is a prospective, single-visit study. The UConn Center on Aging will recruit 80 healthy community-dwelling young (20-35 years old, n=40: 20 men, 20 women) and older adults (>65 years old, n=40: 20 men, 20 women). Blood samples (50 mL, single draw) will be collected from these participants and participants will be clinically assessed using Frailty Index, frailty phenotype and blood-borne measures of biological aging. This research is being done to determine how aging affects the rare blood stem cells that give rise to the circulating immune cells.. Scientists may conduct genomic testing of cells in blood in this research. This means that they will be looking at which genes are turned on and which are turned off in immune cells. This study may help contribute to new strategies to rejuvenate the immune system and responses.
IRB No. 24-125-1 (Dr. Archana Sanjay, PI): Analyzing the impact of aging on skeletal stem and progenitor cells in human bone marrow
This study will examine tissue biospecimens normally discarded from orthopaedic procedures to determine how aging impacts tissue on the cellular level. We plan to collect those discarded biospecimens and transfer them to the Musculoskeletal Institute Research Lab of Dr. Sanjay for preparation and analysis. Using these tissue biospecimens, we will attempt to understand and characterize the effects of aging on a cell's regenerative potential.
IRB No. 24-158JO-2 (Dr. Julie Robison, PI): Skin immunity as a function of frailty, aging, and skin microbiome composition
Specific Aims AIM 1. Identify distinct and common skin immune features associated with aging and frailty-associated dysbiosis (FADS) to inform skin infection risk. AIM 2. Model how aging-related changes in skin infection response are modulated by the microbiome, senescence, inflammation, and genetic diversity. Design and Outcomes This is a prospective, observational, cohort study that will investigate how age-related declines in skin immunity relate to corresponding changes in the skin and its microbiome. Sample Size, Population, Interventions and Duration In this study, 42 participants ages 20-40 years old and 82 participants ages 60 years and older will be enrolled at the UConn Center on Aging in Farmington, CT and will participate in 2-4 study visits over 5 weeks. Visit 2 will occur the day after Visit 1. Visit 3 will occur 21 +/- 7 days after Visit 1 and Visit 4 the day after Visit 3. Skin (swab and micropatch at 7 skin sites) will be collected from participants to study the microbiome, immune profiling of interstitial fluid (ISF), and metabolomics. The seven skin sites will also be probed for skin physiologic metrics associated with frailty and aging.