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NMDA Receptor Antagonist

Memantine for Cognitive Impairment in SLE (ClearMEMory Trial)

Phase 2
Recruiting
Led By Leslie J Crofford, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

ClearMEMory Trial Summary

This trial is testing whether memantine, an NMDA receptor antagonist, is safe and effective in reducing debilitating cognitive symptoms in people with Systemic Lupus Erythematosus (SLE).

Who is the study for?
This trial is for adults aged 18-60 with Systemic Lupus Erythematosus (SLE) who meet specific criteria and have cognitive symptoms. They must not use heavy drugs or alcohol, have had recent medication changes that affect mood/cognition, severe liver/renal disease, be pregnant, or involved in other drug studies.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of Memantine—an NMDA receptor antagonist—against a placebo over 14 weeks to reduce cognitive impairment in SLE patients. It includes blood and urine tests to monitor organ function and pregnancy status.See study design
What are the potential side effects?
Memantine may cause dizziness, headache, confusion, constipation, or tiredness. Since it affects brain chemicals involved in learning and memory, some people might also experience mood changes.

ClearMEMory Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Repeatable Battery for Assessment of Neuropsychological Status (RBANS) Total Index Score at endpoint (Visit 4)
Secondary outcome measures
Beck Depression Inventory
Hospital Anxiety and Depression Scale
Incidence of Treatment-Emergent Adverse Events
+4 more

Side effects data

From 2019 Phase 4 trial • 115 Patients • NCT01902004
23%
Sleepiness/Sedation
10%
Headache
8%
Tension/Inner Unrest
8%
Reduced Salivation
8%
Concentration Difficulties
8%
Diminished Sexual Drive
6%
Asthenia/Lassitude/Increased Fatigability
6%
Constipation
6%
Polyuria/Polydipsia
6%
Orthostatic Dizziness
4%
Nausea/Vomiting
4%
Erectile Dysfunction
4%
Failing Memory
2%
Diarrhea
2%
Increased Duration of Sleep
2%
Reduced Duration of Sleep
2%
Increased Dream Activity
2%
Accomodation Disturbance
2%
Increased Tendancy to Sweating
2%
Weight Gain
2%
Ejaculatory Dysfunction
2%
Micturtion Disturbances
100%
80%
60%
40%
20%
0%
Study treatment Arm
Escitalopram and Placebo
Escitalopram and Memantine

ClearMEMory Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MemantineExperimental Treatment1 Intervention
At randomization, subjects will receive 5 mg twice per day for one week. They will escalate their dose to 10 mg twice per day for one week, then 10 mg in the morning and 20 mg at night for one week, and finally 20 mg twice per day for three weeks. Maximum tolerated will be determined at this time and this dose will be continued for an additional six weeks.
Group II: PlaceboPlacebo Group1 Intervention
At randomization, subjects will receive one matching placebo capsule twice per day for one week. They will also take one matching placebo capsule twice per day for the next week (week 2), then one matching placebo capsule in the morning and two capsules at night for one week (week three), and finally two capsules twice per day for three weeks (weeks 4-6). Maximum tolerated number of capsules will be determined at this time and this dose will be continued for an additional six weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Memantine
2006
Completed Phase 4
~1200

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
857 Previous Clinical Trials
672,113 Total Patients Enrolled
Evergreen Therapeutics, Inc.Industry Sponsor
4 Previous Clinical Trials
568 Total Patients Enrolled
The University of Texas Health Science Center, HoustonOTHER
904 Previous Clinical Trials
320,880 Total Patients Enrolled

Media Library

Memantine (NMDA Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03527472 — Phase 2
Systemic Lupus Erythematosus Research Study Groups: Memantine, Placebo
Systemic Lupus Erythematosus Clinical Trial 2023: Memantine Highlights & Side Effects. Trial Name: NCT03527472 — Phase 2
Memantine (NMDA Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03527472 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you describe other research studies involving Memantine that have been conducted?

"As of the present, Memantine is being tested in 24 separate clinical trials with 11 currently in Phase 3. Out of 294 sites conducting these studies, most are located around Columbus, Ohio."

Answered by AI

How many participants are enrolled in this research initiative?

"Affirmative. Evidence on clinicaltrials.gov shows that this medical trial, which was initially posted 8/23/2018, is currently recruiting subjects. 80 individuals are needed to be recruited from a single location."

Answered by AI

Who meets the criteria to be eligible for this medical research?

"Candidates for this trial must have libman-sacks disease and be within the age range of 18 to 70 years old. A total of 80 individuals are required in order to complete the study."

Answered by AI

Has the U.S. Food and Drug Administration given its endorsement to Memantine?

"Due to the Phase 2 status of Memantine, with existing data attesting to its safety but not efficacy, our team at Power assigned it a risk rating of 2."

Answered by AI

Does this research experiment have any age limitations?

"This clinical trial dictates that prospective participants must be aged 18 or older, but no more than 70."

Answered by AI

Is the current phase of this trial welcoming applicants?

"Affirmative. The clinicaltrials.gov database reveals that this medical trial is actively enrolling patients at the present time, with a first posting date of August 23rd 2018 and last update on May 10th 2022. Eighty participants are needed across one site for completion of the study."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus
Leslie Crofford 2018. "Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03527472.
All > Systemic Lupus Erythematosus > Lupus
~13 spots leftby Jun 2025
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