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ACTIVE NOT RECRUITING
NCT03527472
PHASE2

Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus

Sponsor: Vanderbilt University Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

111

Start Date

2018-08-23

Completion Date

2026-02-28

Last Updated

2026-02-10

Healthy Volunteers

No

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).

Locations (3)

The Cleveland Clinic

Cleveland, Ohio, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

The University of Texas Health Science Center, Houston

Houston, Texas, United States