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Could a common blood pressure pill clear lupus brain fog?

NCT ID NCT04486118

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether two blood pressure drugs, lisinopril and benazepril, can improve memory and concentration in people with lupus. Lupus is an autoimmune disease that can cause inflammation in the brain, leading to cognitive problems. The trial involves 36 adults with lupus and will measure changes in brain activity and cognitive function over 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lisinopril (a blood pressure drug) and benazepril (another blood pressure drug)
What this could lead to
If it works, this could point toward a treatment for lupus-related memory and concentration problems.
What could go wrong
This is a small, early-phase trial with only 36 people, so results may not apply to everyone. It is also testing two similar drugs, so the difference between them may be small.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2021

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject must be able to understand and provide informed consent 2. 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. 3. Subjects must fulfill the 1997 American College of Rheumatology (ACR) revised criteria for the diagnosis of SLE or the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) Criteria or the EULAR/ ACR 2019 criteria for SLE. 4. Subjects must have stable disease activity and medication doses for 4 weeks prior to screening. Stable disease activity is defined as no increase in disease activity requiring an increase or addition of immunosuppressive medications. 5. If on corticosteroids, subjects must be on a dose that is ≤ prednisone 10 mg daily, or the equivalent. 6. Must have increased resting metabolism in the posterior putamen/GP/thalamus on the screening FDG-PET scan that is * \> 1.647 for non-Black SLE subjects and * \> 1.699 for Black SLE subjects. Exclusion Criteria: 1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol. 2. History of neurological diseases including, but not limited to, severe head injury or history of brain surgery, stroke, seizure, toxic exposure, mental retardation, multiple sclerosis, dementia, encephalitis. 3. History of documented transient ischemic attacks within 6 months of screening. 4. Addition of belimumab or rituximab within 3 months of screening and/or addition of disease modifying drugs (such as mycophenolate, methotrexate, azathioprine, leflunomide, voclosporin, tacrolimus) within 3 months of screening. 5. History of illicit drug or alcohol dependence/abuse within the past 12 months. 6. Current use of anxiolytic, anticonvulsant, antidepressant or antipsychotic medications other than specific serotonin reuptake inhibitors (SSRIs) and gabapentin. SSRIs are allowed if the subject is on a stable dose for 12 weeks prior to the screening FDG-PET scan and is expected to remain on the same SSRI throughout the trial. Gabapentin is allowed if used on a PRN basis for pain or reason other than seizure disorder and the subject is willing not to take it for a minimum of 2 weeks prior to brain imaging or neuropsychological assessments. 7. Current and/or chronic use of narcotic analgesia for \> 3 weeks within the last 3 months. 8. Increased disease activity within 4 weeks of screening defined by an increase in SLEDAI by 3 points or more, exclusive of points from serologies, which prompts an increase in or new addition of SLE medications. 9. History of a diagnosis of a primary psychiatric disorder requiring medication that preceded the diagnosis of SLE. 10. Current active acute infections requiring antibiotics within 2 weeks of screening and chronic known infections (eg. hepatitis B, C, and/or HIV). 11. Co-existing other autoimmune disease(s) other than autoimmune thyroid disease or secondary Sjogren's Syndrome. 12. Pregnant and/or lactating women and/or women unwilling to use an acceptable form of contraception. 13. The presence of uncontrolled, severe hypertension, diabetes or heart disease. 14. History of hereditary or idiopathic angioedema. 15. Impaired renal function with an eGFR\< 60%. 16. Current use of aliskiren in diabetic patients. 17. Current use of naltrexone or chronic minocycline use; both are agents also known to alter microglia activation. 18. Use of a centrally acting ACE inhibitor (Lisinopril, fosinopril, ramipril, captopril, perindopril, prinivil, monopril, trandolapril) or angiotensin receptor blocker for more than 4 weeks within the past 1 year. Non-centrally acting ACE inhibitors are allowed if the subject is willing to be randomized to Lisinopril or benazepril instead of their non-centrally acting ACE inhibitor. 19. Known intolerance to ACE inhibitors. 20. Presence of any active medical condition that in the opinion of the investigator may contribute to cognitive and/or behavioral disturbances. 21. Use of investigational drugs within 30 days or 5 half-lives before Visit 1 (Day 1), whichever is longer. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study. 23\. A systolic blood pressure less than 100 mmHg at screening. If the investigator feels that the patient is insufficiently hydrated, the patient may be re-evaluated for blood pressure within the screening period. 24\. Current treatment with Cyclophosphamide. 25. 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. 26\. For subjects consenting to the MRI scans: the presence of ferromagnetic implants or devices that cannot be removed and/or a history of claustrophobia or intolerance of MRI.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Albert Einstein College of Medicine

    The Bronx, New York, 10461, United States

  • Andrew Shaw

    Manhasset, New York, 11030, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Hospital for Special Surgery

    New York, New York, 20021, United States

  • New York University School of Medicine

    New York, New York, 10016, United States

  • Northwell Rheumatology

    Great Neck, New York, 11021, United States

  • Yale University School of Medicine

    New Haven, Connecticut, 06519, United States

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