ACTIVE_NOT_RECRUITING

Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus

Conditions

Lupus Erythematosus, Systemic cognitive dysfunction memantine lupus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2018-08-23

Study Completion:2025-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03527472

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.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Leslie J Crofford, MD

PRINCIPAL_INVESTIGATOR

Professor of Medicine - Rheumatology

Study Locations (Sites)

The Cleveland Clinic

Cleveland, Ohio, 44195

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

The University of Texas Health Science Center, Houston

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-08-23

Study Completion Date2025-07-31

Study Record Updates

Study Start Date2018-08-23

Study Completion Date2025-07-31

Terms related to this study

Keywords Provided by Researchers

cognitive dysfunction
memantine
lupus

Additional Relevant MeSH Terms

Lupus Erythematosus, Systemic