Systemic lupus erythematosusMemantine in Systemic Lupus Erythematosus: A Randomized, Double-Blind Placebo-Controlled Trial
Section snippets
Methods
The study was approved by The Johns Hopkins University School of Medicine Institutional Review Board and was registered with clinicaltrials.gov (clinical trials.gov identifier NCT00181298). All patients gave signed informed consent.
The study was a single-center (Hopkins Lupus Center), double-blind, randomized, placebo-controlled phase 2 trial. The randomization allocation was 2:1 memantine to placebo. Enrollment took place between March 2006 and February 2007 at the Johns Hopkins Hospital. The
Results
The consort diagram is shown in Figure 1. One patient was found to be ineligible after randomization (due to renal dysfunction). Two patients withdrew from the study after 1 month. Demographic and clinical characteristics of the 51 patients that completed the baseline visit are presented in Table 1. The memantine and placebo groups did not differ in demographic characteristics, or in the 11 ACR criteria. The only historical clinical characteristics that significantly differed between treatment
Discussion
This trial is the first randomized trial for mild cognitive impairment in SLE. As such, important lessons were learned. One unexpected finding was that 12 patients (24%) with cognitive impairment by self-report and physician targeted questioning using EULAR guidelines [28] did not score at least a 1 SD below normative data on at least 1 ANAM test and 6 (12%) patients did not on at least 1 ACR cognitive test. The ACR Neuropsychiatric Battery appears to be more sensitive than ANAM in detecting
Conclusion
In conclusion, the trial was slightly underpowered, because 12% of patients with self-reported and physician-confirmed cognitive impairment did not exhibit significant impairment at baseline on any of the cognitive measures. Possible improvement was seen in 2 cognitive domains: continuous performance and simple reaction time, with significant improvement in 1 domain: oral word association. These results can be used to select appropriate patients and to power future clinical trials for cognitive
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Cited by (0)
This study was supported in part by Forest Laboratories, Inc., NIH RO1 AR049125, and by Grant UL1 RR 025005 from the National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH) and NIH Roadmap for Medical Research, and its contents are solely the responsibility of the authors and do not necessarily represent the official view of NCRR or NIH.
The authors have no conflicts of interest to disclose.