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NCT04486118 · ClinicalTrials.gov registry record · Phase 2
Centrally Acting ACE Inhibition in SLE
A Phase 2 study of Systemic Lupus Erythematosus, sponsored by Northwell Health.
- Active
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 7
- Study locations
NCT04486118: Active Phase 2 study of Systemic Lupus Erythematosus, sponsored by Northwell Health.
NCT04486118 is a Phase 2 study of Systemic Lupus Erythematosus that is active but no longer recruiting, run by Northwell Health. The registered enrollment target is 36 participants, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (91% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04486118, a Phase 2 study of Systemic Lupus Erythematosus, is active but no longer recruiting, sponsored by Northwell Health.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 7
- Study locations
Study 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.
Primary Outcome
The primary outcome measure for evaluation of the primary objective will be the change in regional metabolism between baseline and 12 months in the posterior putamen/GP/thalamus on FDG-PET imaging.
Conditions Studied
Interventions
- DRUG Lisinopril Pills
- DRUG Benazepril Pill
Study Locations (7)
New York
- Northwell Rheumatology - Great Neck
- Andrew Shaw - Manhasset
- New York University School of Medicine - New York
- Columbia University Medical Center - New York
- Hospital for Special Surgery - New York
- Albert Einstein College of Medicine - The Bronx
Connecticut
- Yale University School of Medicine - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2021-10-01 |
| Est. Completion | 2026-03-01 |
| Phase | Phase 2 |
What the registry record for NCT04486118 still lists
NCT04486118 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 2 interventions - of which Lisinopril Pills is the first listed.
NCT04486118 lists 7 locations in 2 states (New York, Connecticut).
Frequently Asked Questions
What is clinical trial NCT04486118 about?
NCT04486118 is a clinical study titled "Centrally Acting ACE Inhibition in SLE". 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 orga...
What is the current status of trial NCT04486118?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2021-10-01. Estimated completion is 2026-03-01.
What conditions does trial NCT04486118 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus.
What interventions are being tested in trial NCT04486118?
The interventions under investigation include: Lisinopril Pills (DRUG), Benazepril Pill (DRUG).
Who is sponsoring clinical trial NCT04486118?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04486118 being conducted?
This trial has 7 study locations across Connecticut, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04486118's enrollment target sits among peer trials
36 79th of 99 higher than 19 of 99 other Systemic Lupus Erythematosus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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