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ACTIVE NOT RECRUITING
NCT04486118
PHASE2

Centrally Acting ACE Inhibition in SLE

Sponsor: Northwell Health

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2021-10-01

Completion Date

2026-03-01

Last Updated

2025-09-19

Healthy Volunteers

No

Interventions

DRUG

Lisinopril Pills

Tablets will be taken by oral administration daily, based on titration

DRUG

Benazepril Pill

Tablets will be taken by oral administration daily, based on titration

Locations (7)

Yale University School of Medicine

New Haven, Connecticut, United States

Northwell Rheumatology

Great Neck, New York, United States

Andrew Shaw

Manhasset, New York, United States

New York University School of Medicine

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Hospital for Special Surgery

New York, New York, United States

Albert Einstein College of Medicine

The Bronx, New York, United States