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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

Must not have

Current use of aliskiren in diabetic patients

The presence of suicidal ideation on the Beck Depression Inventory at screening or sufficient depressive symptoms to warrant intervention with pharmacologic therapy and/or referral for treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a diabetic patient currently using aliskiren.

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I have thoughts of harming myself or have been very depressed.

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I am currently being treated with Cyclophosphamide.

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I have been using pain medication regularly for more than 3 weeks in the last 3 months.

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My lupus symptoms have worsened recently, leading to a change in my medication.

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I have no history of severe neurological diseases or brain injuries.

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I do not have uncontrolled severe high blood pressure, diabetes, or heart disease.

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My kidney function is reduced with an eGFR below 60%.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Brain Metabolism

Secondary study objectives

2x2 spatial memory task

Automated Neuropsychological Assessment Metrics (ANAM)

Disease Activity

+7 more

Trial 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

0 / 11Eligibility criteria met