A phase 2 multisite, randomised, placebo-controlled 12-week trial (ClearMEMory; NCT03527472) evaluated memantine (titrated to 40 mg/day) vs. placebo in adults with SLE and objective neuropsychological dysfunction, with the primary outcome being change in RBANS total score at week 12.
Memantine produced a greater median RBANS score improvement than placebo (+8 vs. +5; P=.032); 66.7% vs. 36.0% of participants met the clinically important threshold of ≥8-point increase (P=.047; NNT=3.3). Patient-reported global improvement did not reach significance (61% vs. 36%; P=.19). Adverse-event discontinuation rates were similar (19% vs. 17%).
Small analysed sample (n=43 of 56 randomised) limits statistical power and generalisability; the PGI-C patient-reported outcome did not reach significance, suggesting a possible disconnect between objective and subjective benefit; 12-week follow-up is short for a chronic condition.
For adults with SLE-associated cognitive dysfunction, a 12-week course of memantine (up to 40 mg/day) improved objective neuropsychological scores with an NNT of 3.3 and a tolerability profile similar to placebo. Clinicians should weigh this early-phase evidence cautiously pending larger confirmatory trials.
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