NCT03527472

Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus

A Randomized Placebo-controlled, Double Blind Phase 2 Clinical Trial of Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A phenome-wide association study (PheWAS) identified an association between a variant in the human gene for the N2A subunit of the N-methyl-D-aspartate (NMDA) receptor, GRIN2A, and Systemic Lupus Erythematosus (SLE). A single nucleotide polymorphism (SNP) in this gene encodes for increased NMDA receptor activity. Based on the potential function of the associated SNP and published literature, alterations in SNP function signaling may underlie a cluster of symptoms. The objective of this study is to evaluate the safety, tolerability and efficacy of memantine, an NMDA receptor antagonist, in a precise patient subset with SLE. Participants will complete a full 14-week clinical trial, receiving either memantine or a placebo. Participants' blood will be drawn to test for various antibodies as well as organ function. Patients' urine will also be collected to assess organ function and pregnancy for females at a number of specific time points. The overall goal is to develop a safe and inexpensive therapeutic approach to reduce debilitating cognitive symptoms in a precisely selected SLE sub-population.

Conditions

• Lupus Erythematosus, Systemic

Interventions

Type	Name	Description
DRUG	Memantine	Memantine is an FDA-approved drug for the treatment of Alzheimer's disease.
DRUG	Placebo	The placebo will match the study drug in appearance, dose, and frequency. It will not contain any active drug (memantine).

Timeline

• Start date: 2018-08-23
• Primary completion: 2026-02-28
• Completion: 2026-02-28
• First posted: 2018-05-17
• Last updated: 2026-02-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study