Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus

Description

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

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Study Overview

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Study Details

Study overview

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.

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

Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus

Condition
Lupus Erythematosus, Systemic
Intervention / Treatment

-

Contacts and Locations

Cleveland

The Cleveland Clinic, Cleveland, Ohio, United States, 44195

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232

Houston

The University of Texas Health Science Center, Houston, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Meet American College of Rheumatology (ACR) criteria for SLE
  • 2. Report NPSLE symptoms on the screening survey recommended by EULAR guideline but limited to the psychiatric manifestations questions
  • 3. Score ≤ 85 on the RBANS total index (≤ 1 SD below the normative mean of 100)
  • 1. Male and female subjects \<18 or \>60 years
  • 2. Change in medication that may affect mood or cognition including prednisone, antidepressant medications, or stimulants within the last 4 weeks
  • 3. Regular (daily) use of opioids or other drugs of abuse including heavy alcohol or marijuana use
  • 4. Metabolic derangement defined as liver function tests \>3x upper limit of normal or severe renal disease defined as calculated creatinine clearance \<30 mL
  • 5. Severe psychiatric disease including schizophrenia, psychosis, suicidal depression
  • 6. 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)
  • 7. Inability or refusal to give informed consent for any reason including a diagnosis of dementia or significant cognitive impairment\*\*
  • 8. Patients who are pregnant
  • 9. Patients who are enrolled in other investigational drug studies

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vanderbilt University Medical Center,

Leslie J Crofford, MD, PRINCIPAL_INVESTIGATOR, Professor of Medicine - Rheumatology

Study Record Dates

2025-07-31