Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 29 May 2023
• Main ID: NCT03527472
• Date of registration: 03/05/2018
• Prospective Registration: Yes
• Primary sponsor: Vanderbilt University Medical Center
• Public title: Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus ClearMEMory
• Scientific title: A Randomized Placebo-controlled, Double Blind Phase 2 Clinical Trial of Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus
• Date of first enrolment: August 23, 2018
• Target sample size: 80
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03527472
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Jon Williams, PhD

• Name: Leslie J Crofford, MD
• Affiliation: Professor of Medicine - Rheumatology

• Name: Jonathan M Williams, PhD

Key inclusion & exclusion criteria

Inclusion 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)

Exclusion Criteria:

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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lupus Erythematosus, Systemic

Intervention(s)

Drug: Placebo

Drug: Memantine

Primary Outcome(s)

Repeatable Battery for Assessment of Neuropsychological Status (RBANS) Total Index Score at endpoint (Visit 4) [Time Frame: 12 weeks]

Secondary Outcome(s)

Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K [Time Frame: 12 weeks]

Polysymptomatic Distress Scale [Time Frame: 12 weeks]

Patient Global Impression of Change [Time Frame: Endpoint (Visit 4)]

Hospital Anxiety and Depression Scale [Time Frame: 12 weeks]

RBANS Subscales [Time Frame: 12 weeks]

Beck Depression Inventory [Time Frame: 12 weeks]

Incidence of Treatment-Emergent Adverse Events [Time Frame: 12 weeks]

Secondary ID(s)

180256

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The Cleveland Clinic

The University of Texas Health Science Center, Houston

Evergreen Therapeutics, Inc.