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This study evaluates the drug Memantine, compared with a placebo, for treating cognitive impairment in patients with systemic lupus erythematosus. It enrolled patients who met lupus diagnostic criteria and scored below a defined level on a cognitive test. The study was conducted in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1. Meet American College of Rheumatology (ACR) criteria for SLE 2. Report NPSLE symptoms on the screening survey recommended by EULAR guideline but limited to the psychiatric manifestations questions 3. Score ≤ 85 on the RBANS total index (≤ 1 SD below the normative mean of 100) Exclusion Criteria: 1. Male and female subjects \<18 or \>60 years 2. Change in medication that may affect mood or cognition including prednisone, antidepressant medications, or stimulants within the last 4 weeks 3. Regular (daily) use of opioids or other drugs of abuse including heavy alcohol or marijuana use 4. Metabolic derangement defined as liver function tests \>3x upper limit of normal or severe renal disease defined as calculated creatinine clearance \<30 mL 5. Severe psychiatric disease including schizophrenia, psychosis, suicidal depression 6. Other factors which in the opinion of the investigator could potentially impact the study outcomes (e.g., underlying disease, medications, history)\* or prevent the participant from completing the protocol (poor compliance or unpredictable schedule) 7. Inability or refusal to give informed consent for any reason including a diagnosis of dementia or significant cognitive impairment\*\* 8. Patients who are pregnant 9. Patients who are enrolled in other investigational drug studies