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:
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Conditions: Lupus Erythematosus
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Age: Between 18 Year(s) - 55 Year(s)
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Gender: Male or Female
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Other Inclusion Criteria:
- Able to understand and provide informed consent
- 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.
- Must have stable disease activity and medication doses for 4 weeks prior to screening.
- If on corticosteroids, must be on a dose that is = prednisone 10 mg daily, or equivalent
- 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:
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- Unable to provide written informed consent
- 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
- History of documented transient ischemic attacks within 6 months of screening.
- Limited fluency with English
- Addition of belimumab or rituximab within 3 months of screening and/or addition of disease modifying drugs within 3 months of screening.
- History of illicit drug or alcohol dependence/abuse
- Current use of anxiolytic, anticonvulsant, antidepressant or antipsychotic medications.
- Current and/or chronic use of narcotic analgesia for > 3 weeks within the last 3 months
- Increased disease activity within 4 weeks of screening
- History of a diagnosis of a primary psychiatric disorder requiring medication preceding SLE diagnosis
- Current active acute infections requiring antibiotics within 2 weeks of screening and chronic known infections
- Co-existing other autoimmune disease(s) other than autoimmune thyroid disease and secondary Sjogren’s Syndrome.
- Pregnant and/or lactating women and/or women unwilling to use an acceptable form of contraception.
- The presence of uncontrolled, severe hypertension, diabetes or heart disease.
- History of hereditary or idiopathic angioedema
- Impaired renal function with an eGFR< 60%.
- Current use of aliskiren in diabetic patients
- Current use of naltrexone or chronic minocycline use; both are agents also known to alter microglia activation.
- Current use of aliskiren in diabetic patients
- Current use of naltrexone or chronic minocycline use; both are agents also known to alter microglia activation
- Current use of an ACE inhibitor or angiotensin receptor blocker or use for more than 4 weeks within the past 1 year
- Known intolerance to ACE inhibitors
- Presence of any active medical condition that in the opinion of the investigator may contribute to cognitive and/or behavioral disturbances
- Use of investigational drugs within 30 days
- A systolic blood pressure less than 100 mmHg at screening
- Current treatment with Cyclophosphamide
- The presence of suicidal ideation on the Beck Depression Inventory at screening
- 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.
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.