Centrally Acting ACE Inhibition in SLE (NCT04486118)
A Novel Phase 2 Double-blind, Randomized, Controlled Clinical Trial to Evaluate the Efficacy of Centrally Acting, Non-toxic ACE Inhibition in Cognitive Impairment Associated With SLE
๐ฉบ Plain-English Summary (8th-Grade Level)
SLE is a chronic autoimmune disease that often involves multiple systems and organs of the body. An autoimmune disease is one which your immune system attacks the cells and tissues in different parts of the body. SLE is characterized by inflammation that leads to tissue damage in many different organ systems. Lupus can cause fever, joint pains, rashes, and other symptoms. It can also affect organs such as the skin, the muscles, the kidneys, the heart, the lungs, the blood and the brain. The exact cause of SLE is not known. Problems with memory and concentration are common in lupus; these problems are called cognitive problems. Cognitive problems can be caused by things like depression, fatigue, medication and infections. However, previous studies that have been done in animal models of lupus and in lupus patients suggest that inflammation due to lupus can affect the brain directly. This research study is being done to test the effects of centrally-acting ACE inhibitor, named lisinopril, on resting metabolism in the brain and on cognitive function. The investigators will see if Lisinopril will decrease resting metabolism in the brain and improve cognitive function (memory and concentration) compared to a non-centrally acting ACE inhibitor called benazepril.
Who can join: Review the eligibility criteria below.
Location: Yale University School of Medicine โ New Haven, Connecticut
Age range: 18 Years to 55 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (7 Sites)
- Yale University School of Medicine โ New Haven, Connecticut
- Northwell Rheumatology โ Great Neck, New York
- Andrew Shaw โ Manhasset, New York
- New York University School of Medicine โ New York, New York
- Columbia University Medical Center โ New York, New York
- Hospital for Special Surgery โ New York, New York
- Albert Einstein College of Medicine โ The Bronx, New York
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Systemic Lupus Erythematosus
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- A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus โ Anniston, Alabama
- REACH (Restore Energy, Activity Can Help) Lupus Study โ Boston, Massachusetts
- Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus โ Birmingham, Alabama
- A Treatment Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice โ Innsbruck, Tyrol
- A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) โ Birmingham, Alabama
Explore by condition: All Systemic Lupus Erythematosus clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.