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Clinical Trials: Aging
IRB No. 17-021S-1 (Dr. Richard Fortinsky, PI): Care Management for Cognitively Vulnerable Older Adults
The purpose of the study is to compare ways to support the health of people over age 65 who may be experiencing signs of memory problems, feelings of sadness, or feelings of confusion. The study will look at how nurses, social workers and other health care professionals can help older adults get the care they need and to stay as healthy as possible. This type of support provided by these healthcare professionals is called "care management services". The study will compare two different care management teams: "Home Based Care Team" and "Telephone Based Care Team". The "Home Based Care Team" (HBCT) is composed of a nurse practitioner who is specifically trained to provide care and psychosocial support to older adults, social worker, physical and occupational therapists, registered dietician, pharmacist and community health educator. The Home Based Care Team nurse practitioner will lead this care management team. Interaction with the team will primarily take place within the older adult's home. The "Telephone Based Care Team" (TBCT) is composed of a nurse care manager who will assess the older adult's current health status and provide referrals to other healthcare professionals as needed. Interaction with the "Telephone Based Care Team" will primarily take place over the phone.
IRB No. 14-194J-3.2 (Dr. George Kuchel, PI): Impact of aging on gene expression and RNA splice variants in peripheral blood cells
PRIMARY HYPOTHESIS We will be able to gain a comprehensive view of the genomic alterations associated with aging and frailty using immunological and system biology approaches. Furthermore, we theorize that these changes will be associated with specific microbiome composition. SPECIFIC AIMS This is a single-center exploratory study to carry out transcriptional and microbiome profiling analysis to gain a comprehensive view of genomic alterations associated with aging and frailty. Aim 1: To collect the samples from well-characterized volunteer cohorts. Aim 2: To establish whole blood isoform profiles. Aim 3: To establish epigenetic profiles of PBMCs and sorted blood cells Aim 4: To characterize microbiome in saliva and stool samples. Aim 5: To devise informatics methods to uncover the dynamics of transcriptional regulatory program associated with pathologies in human cells, in particular with the aging of immune cells. Aim 6: To evaluate epigenetic data using developed algorithms to address the following questions: 6a: Which regulatory programs and regulatory interactions are disrupted with aging and in which immune cells? 6b. How do men and women age differently based on transcriptional data (sex effects)? 6c. What are the putative genomic/clinical/immunological markers of healthy aging? SIGNIFICANCE It becomes critically important to apply system biology approaches and in-depth genomics to understand aging and related alterations. Identifying the immunologic parameters that correlate with or predict immune alterations will have a significant impact on the increased understanding of disease physiology in older age and eventually novel biomarkers and targets for therapy. RELEVANCE Recent technological breakthroughs have made the study of biological systems on a large scale a reality, thus offering unprecedented opportunities to comprehensively profile genome and immune responses in human subjects. A major challenge when engaging in such studies is to establish baseline values in subjects over time under "healthy" conditions. This data will be used as a basis for design of futures studies identifying changes occurring in response to challenge as for example acute infection or vaccination.
IRB No. 21-174O-2 (Dr. Matthew Costello, PI): Effect of Bladder Interoception on Simulated Driving Performance Under Increasing Cognitive Load
This project will examine how your ability to drive may be affected by the feeling of your bladder, and how this changes in older age. The purpose of this research is to understand how the aging mind and bladder can interact to distract one’s ability to drive a car. In the testing, we will modify and measure your bladder levels while you operate a car simulator. We will also test you in a variety of cognitive and physical tests, and questionnaires that measure thinking ability, physical health, and psychological condition.
IRB No. 21-257-2 (Dr. Breno Diniz, PI): The SenDep Study: Linking Molecular Senescence Changes to Depression and Cognitive Impairment in Late Life
Late-life depression (LLD) is a common mental disorder in the elderly, with prevalence rates ranging from 1 to 5%. Recent evidence suggests that LLD is linked to age-related negative health outcomes, such as cerebrovascular disease, increased risk of Alzheimer's disease, vascular dementia, and of premature mortality. The mechanisms of LLD are complex and involve the dysregulation of different biological pathways. Understanding the interplay between the biological changes in aging and depression can provide insight into the mechanisms by which LLD increases the risk of negative health outcomes. This study proposes to evaluate the association of Senescence-Associated Secretory Phenotype (SASP) Index with different clinical phenotypes of aging (i.e., cognitive impairment) and with cellular senescence phenotype (i.e., leukocyte telomere [LT] attrition) in LLD. Finally, we will evaluate the trajectory of changes in SASP, and its relationship with cognitive performance in these individuals. Our hypotheses are that LLD individuals will show a significantly higher SASP index compared to age- and gender-matched never-depressed control subjects. SASP index will be significantly associated with greater cognitive impairment and telomere attrition in LLD subjects. We further hypothesize that an increasing or persistently higher SASP index trajectory will lead to faster cognitive decline among study participants over two years of follow-up. To our knowledge, this will be the first study to examine the association between circulating molecular senescence markers (SASP), a cellular senescence marker (LT attrition), and neurocognitive and clinical characteristics in LLD. Based on the results of this study, we will also be able to identify novel targets for the development of interventions aiming not only the treatment of depression in the elderly but also aiming the prevention of the negative outcomes related to this condition
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.