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Life sciences · Phase 1 Trial
ClinicalTrials.gov · October 2, 2026
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Phase 1 Trial.
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Registry record from ClinicalTrials.gov (NCT07856043). This is a study registration, not published results. Lead sponsor: Stony Brook University. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 18 participants (ESTIMATED). Conditions: Heart Failure With Reduced Ejection Fraction, Cognitive Impairment, Mild, Neuroinflammation, Vascular Contributions to Cognitive Impairment and Dementia (VCID). Interventions: DRUG: [11C]PS13: [carbon-11]PS13; COX-1 PET radioligand; DRUG: Sacubitril-Valsartan. Primary outcome measures: Change in [11C]PS13 Total Distribution Volume (VT) in Global Gray Matter , Baseline (Visit 2, prior to sacubitril-valsartan initiation) and approximately 12 weeks after initiation (Visit 4). Brief summary: Heart failure reduces the amount of blood the heart pumps, which can lead to memory and thinking problems in many patients. One possible reason is that heart failure triggers brain inflammation, a process in which certain brain immune cells (called microglia) become overactive. A heart failure medication called sacubitril-valsartan has been shown to reduce the risk of developing dementia, but it is not known whether this is because it reduces brain inflammation. This study uses a new experimental brain scan drug called \[11C\]PS13 (PS13) to measure brain inflammation directly and non-invasively, using a technique called positron emission tomography (PET). PS13 sticks to a molecule called COX-1, which is found mainly in brain immune cells (microglia). By measuring how much PS13 accumulates in the brain, researchers can estimate how much brain inflammation is present. In this pilot study, 18 patients with heart failure and mild memory or thinking problems who are being started on sacubitril-valsartan by their cardiologist (as standard clinical care) will undergo two brain PET scans: one before starting sacubitril-valsartan, and one approximately 12 weeks after. The study will also assess memory, thinking, daily function, mood, and social well-being using standard questionnaires. The study will test whether sacubitril-valsartan is associated with measurable changes in brain inflammation, and whether this type of imaging is feasible in heart failure patients. The study is funded by the American Heart Association and the National Institute on Aging, and an independent Data and Safety Monitoring Board oversees participant safety. The results will be used to design a larger study.