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NCT03527472 · ClinicalTrials.gov registry record · Phase 2

Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus

A Phase 2 study of Lupus Erythematosus, Systemic, sponsored by Vanderbilt University Medical Center.

Active
Registry status
Phase 2
Development phase
111
Enrollment target
3
Study locations

NCT03527472 is a Phase 2 study of Lupus Erythematosus, Systemic that is active but no longer recruiting, run by Vanderbilt University Medical Center. The registered enrollment target is 111 participants, below the 200-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target (44% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT03527472, a Phase 2 study of Lupus Erythematosus, Systemic, is active but no longer recruiting, sponsored by Vanderbilt University Medical Center.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
111 participants
Enrollment target
3
Study locations

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 Studied

Lupus Erythematosus, Systemic

Interventions

  • DRUG Placebo
  • DRUG Memantine

Study Locations (3)

Ohio

  • The Cleveland Clinic - Cleveland

Tennessee

  • Vanderbilt University Medical Center - Nashville

Texas

  • The University of Texas Health Science Center, Houston - Houston

Trial Details

FieldValue
Enrollment Target 111 participants
Start Date 2018-08-23
Est. Completion 2026-02-28
Phase Phase 2

Sponsor

Vanderbilt University Medical Center

677 total trials

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What the Registry Record Tells You About NCT03527472

The ClinicalTrials.gov registry entry for NCT03527472 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 111 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 200-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target (44% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Lupus Erythematosus, Systemic appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03527472 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Ohio, Tennessee, Texas.

Frequently Asked Questions

What is clinical trial NCT03527472 about?

NCT03527472 is a clinical study titled "Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus". 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 rece...

What is the current status of trial NCT03527472?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 111 participants. The study started on 2018-08-23. Estimated completion is 2026-02-28.

What conditions does trial NCT03527472 study?

This clinical trial studies the following conditions: Lupus Erythematosus, Systemic.

What interventions are being tested in trial NCT03527472?

The interventions under investigation include: Placebo (DRUG), Memantine (DRUG).

Who is sponsoring clinical trial NCT03527472?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03527472 being conducted?

This trial has 3 study locations across Ohio, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.