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ACE Inhibitor
ACE Inhibitors for Lupus
Phase 2
Recruiting
Led By Meggan Mackay, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
If on corticosteroids, subjects must be on a dose that is ≤ prednisone 10 mg daily, or the equivalent
Subjects must be ≥18 and ≤65 years of age: subjects with age > 65 will be excluded to avoid confounding effects of age on cognitive testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is testing if the drug lisinopril can help people with lupus by decreasing metabolism in the brain and improving cognitive function.
Who is the study for?
Adults aged 18-65 with stable Systemic Lupus Erythematosus (SLE) can join this trial. They must meet specific SLE diagnostic criteria, have no recent severe neurological issues or drug abuse, and not be on certain medications like high-dose steroids or narcotics. Pregnant women and those with uncontrolled hypertension, diabetes, heart disease, or impaired kidney function are excluded.Check my eligibility
What is being tested?
The study is testing if Lisinopril pills—a centrally acting ACE inhibitor—can improve brain metabolism and cognitive functions such as memory and concentration in SLE patients compared to Benazepril pills which do not act centrally.See study design
What are the potential side effects?
Possible side effects of ACE inhibitors like Lisinopril may include coughing, increased potassium levels that could affect the heart rhythm, low blood pressure especially after the first dose, dizziness due to blood pressure changes, headaches, fatigue and rarely swelling of tissues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am taking a low dose of steroids, not more than the equivalent of 10 mg of prednisone daily.
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I am between 18 and 65 years old.
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I understand the study and can give my consent.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Brain Metabolism
Secondary outcome measures
2x2 spatial memory task
Automated Neuropsychological Assessment Metrics (ANAM)
Disease Activity
+7 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: CA-ACEiActive Control1 Intervention
Enrolled subjects will begin treatment with a low dose of study drug (5 mg) Study drug will then be titrated up as follows, provided the increased dose is tolerated:
Day 3-15 (dosing begins after completion of FIMR Visit 1.1): 5 mg Day 29: 10 mg Day 43: 20 mg Day 57: 40 mg if tolerated Subjects will be required to achieve and maintain a minimum dose of 20 mg daily to ensure adequate dosage of the ACE inhibitor.
Group II: nonCA-ACEiPlacebo Group1 Intervention
Enrolled subjects will begin treatment with a low dose of study drug (5 mg) Study drug will then be titrated up as follows, provided the increased dose is tolerated:
Day 3-15 (dosing begins after completion of FIMR Visit 1.1): 5 mg Day 29: 10 mg Day 43: 20 mg Day 57: 40 mg if tolerated Subjects will be required to achieve and maintain a minimum dose of 20 mg daily to ensure adequate dosage of the ACE inhibitor.
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Who is running the clinical trial?
Lupus Research AllianceOTHER
5 Previous Clinical Trials
3,830 Total Patients Enrolled
Northwell HealthLead Sponsor
461 Previous Clinical Trials
471,099 Total Patients Enrolled
Meggan Mackay, MDPrincipal InvestigatorThe Feinstein Institute for Medical Research
3 Previous Clinical Trials
108 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any experimental drugs recently.I am taking a low dose of steroids, not more than the equivalent of 10 mg of prednisone daily.I am between 18 and 65 years old.I am a diabetic patient currently using aliskiren.I have thoughts of harming myself or have been very depressed.I am currently being treated with Cyclophosphamide.I have been using pain medication regularly for more than 3 weeks in the last 3 months.My lupus symptoms have worsened recently, leading to a change in my medication.I understand the study and can give my consent.I do not have any active infections needing antibiotics or chronic infections like hepatitis or HIV.My disease has been stable without needing more medicine for the last 4 weeks.I have been taking specific blood pressure medication for over 4 weeks in the past year.I am not taking any mental health drugs except for SSRIs or gabapentin.I have started new medications for my condition within the last 3 months.I have had a mini-stroke in the last 6 months.I have no history of severe neurological diseases or brain injuries.I do not have uncontrolled severe high blood pressure, diabetes, or heart disease.My kidney function is reduced with an eGFR below 60%.I am currently taking naltrexone or minocycline regularly.
Research Study Groups:
This trial has the following groups:- Group 1: CA-ACEi
- Group 2: nonCA-ACEi
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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