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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Lupus Erythematosus
  • Age: Between 18 Year(s) - 55 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Able to understand and provide informed consent
    2. 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.
    3. Must have stable disease activity and medication doses for 4 weeks prior to screening.
    4. If on corticosteroids, must be on a dose that is = prednisone 10 mg daily, or equivalent
    5. Must have increased resting metabolism in the posterior putamen/GP/thalamus on the screening FDG-PET performed prior to study enrollment scan that is > 1.647 for non-Black SLE subjects and > 1.699 for Black SLE subjects.

You may not be eligible for this study if the following are true:

    1. Unable to provide written informed consent
    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. Limited fluency with English
    5. Addition of belimumab or rituximab within 3 months of screening and/or addition of disease modifying drugs within 3 months of screening.
    6. History of illicit drug or alcohol dependence/abuse
    7. Current use of anxiolytic, anticonvulsant, antidepressant or antipsychotic medications.
    8. Current and/or chronic use of narcotic analgesia for > 3 weeks within the last 3 months
    9. Increased disease activity within 4 weeks of screening
    10. History of a diagnosis of a primary psychiatric disorder requiring medication preceding SLE diagnosis
    11. Current active acute infections requiring antibiotics within 2 weeks of screening and chronic known infections
    12. Co-existing other autoimmune disease(s) other than autoimmune thyroid disease and secondary Sjogren’s Syndrome.
    13. Pregnant and/or lactating women and/or women unwilling to use an acceptable form of contraception.
    14. The presence of uncontrolled, severe hypertension, diabetes or heart disease.
    15. History of hereditary or idiopathic angioedema
    16. Impaired renal function with an eGFR< 60%.
    17. Current use of aliskiren in diabetic patients
    18. Current use of naltrexone or chronic minocycline use; both are agents also known to alter microglia activation.
    19. Current use of aliskiren in diabetic patients
    20. Current use of naltrexone or chronic minocycline use; both are agents also known to alter microglia activation
    21. Current use of an ACE inhibitor or angiotensin receptor blocker or use for more than 4 weeks within the past 1 year
    22. Known intolerance to ACE inhibitors
    23. Presence of any active medical condition that in the opinion of the investigator may contribute to cognitive and/or behavioral disturbances
    24. Use of investigational drugs within 30 days
    25. A systolic blood pressure less than 100 mmHg at screening
    26. Current treatment with Cyclophosphamide
    27. The presence of suicidal ideation on the Beck Depression Inventory at screening
    28. 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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