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Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus

NCT03527472 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2026-04-22

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Evergreen Therapeutics, Inc.

    collaborator INDUSTRY

  • The University of Texas Health Science Center, Houston

    collaborator OTHER

  • The Cleveland Clinic

    collaborator OTHER

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Leslie J Crofford, MD · Professor of Medicine - Rheumatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-23
Primary Completion
2026-02-28
Completion
2026-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03527472 on ClinicalTrials.gov