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With generous support from the WoodNext Foundation, the Aging Institute is launching the “Reducing Inflammation for Greater Health Trial (RIGHT).” In this novel clinical trial, Anne B. Newman, MD, MPH, director for the Center for Aging and Population Health, distinguished professor of Epidemiology, professor of Medicine and Clinical and Translational Science in the Division of Geriatric Medicine, and clinical director at the Aging Institute of the University of Pittsburgh/UPMC, will test whether clazakizumab, a novel inhibitor of interleukin-6 (IL-6), can improve physical and cognitive function in older men and women.
Modest elevations of IL-6 and other cytokines are common in older adults, leading to a slowing in physical and cognitive function, as well as several chronic diseases.
The WoodNext Foundation supports the development of new targets to address inflammation in Projects 1 and 2, while Project 3 — the RIGHT study — leverages potential benefits from an existing anti-inflammatory drug to improve aging outcomes, including brain and vascular health.
Evidence from the cardiovascular field supports the approach of Dr. Newman’s research. Canakinamab, a monoclonal antibody to interleukin 1 beta (IL1beta), has been shown to reduce recurrent cardiovascular events in patients with cardiovascular disease, and this effect seems to be due to a reduction in IL-6 signaling. Monoclonal antibodies to cytokines and their receptors have been widely used in rheumatological diseases, such as rheumatoid and psoriatic arthritis.
The drug being used in RIGHT is clazakizumab, which targets IL-6 directly. Clazakizumab has already been tested in rheumatological disease and other conditions of excess inflammation and is being provided to the RIGHT study at no cost by CSL Behring. RIGHT will test the effects of clazakizumab on endurance and fatigue, vascular stiffness, endothelial function, and markers of brain health, including cognitive tests, biomarkers of neurodegeneration, and functional brain MRI to assess neurovascular coupling. Additional assessments will include changes in immune cell frequencies, response to stimuli, and changes in multiple pro- and anti-inflammatory cytokines. A repository of serum, plasma and peripheral blood mononuclear cells will be established to allow additional tests of biomarkers in the future.
Recruitment began in June 2023 and has used mailing lists to reach older adults in the community. Volunteers will be screened in the Health Studies Research Center located in the Bellefield Professional Building in North Oakland. Eligible candidates must be at least age 70, have IL-6 levels averaging 2.5 pg/ ml on two occasions about two weeks apart, and have no serious medical problems. The recruitment period is anticipated to continue over a one-year period, with a six-month treatment period for each participant. People ages 70 and older interested in joining the study can email RIGHT-Study@pitt.edu or leave a voicemail at 800-872-3653.