NCT03527472CompletedPhase 2

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

Source: ClinicalTrials.gov · Last updated 22 Apr 2026

Brief summary (registry, in English)

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.

Status (registry): Completed
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 111 (actual)
First submitted: 3 May 2018
Start date: 23 Aug 2018
Primary completion date: 28 Feb 2026
Lead sponsor: Vanderbilt University Medical Center
Diseases: Lupus (SLE)
NCT number: NCT03527472

What you commit to

Study type: Interventional · Phase 2
Participants enrolled: 111
From 23 Aug 2018 to the primary completion date, 28 Feb 2026
3 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Change in medication that may affect mood or cognition including prednisone, antidepressant medications, or stimulants within the last 4 weeks
Regular (daily) use of opioids or other drugs of abuse including heavy alcohol or marijuana use
Patients who are enrolled in other investigational drug studies

Other illness

Severe psychiatric disease including schizophrenia, psychosis, suicidal depression
Other factors which in the opinion of the investigator could potentially impact the study outcomes (e.g., underlying disease, medications, history)\* or prevent the participant from completing the protocol (poor compliance or unpredictable schedule)
Inability or refusal to give informed consent for any reason including a diagnosis of dementia or significant cognitive impairment\*\*

Lab values

Metabolic derangement defined as liver function tests \>3x upper limit of normal or severe renal disease defined as calculated creatinine clearance \<30 mL

Age

Male and female subjects \<18 or \>60 years

Other

Patients who are pregnant

Who the study is looking for

Meet American College of Rheumatology (ACR) criteria for SLE
Report NPSLE symptoms on the screening survey recommended by EULAR guideline but limited to the psychiatric manifestations questions
Score ≤ 85 on the RBANS total index (≤ 1 SD below the normative mean of 100)

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
The Cleveland Clinic Coordinator of this site? Confirm its status	Cleveland	United States	Unknown status
The University of Texas Health Science Center Houston Coordinator of this site? Confirm its status	Houston	United States	Unknown status
Vanderbilt University Medical Center Coordinator of this site? Confirm its status	Nashville	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.