Overview

Memantine in Systemic Lupus Erythematosus

Status:
Completed
Trial end date:
2007-05-01
Target enrollment:
0
Participant gender:
All
Summary
Neuropsychiatric manifestations of Systemic Lupus Erythematosus (NPSLE) are both common and an important source of morbidity. Of the case definitions for NPSLE syndromes that have recently been developed, cognitive dysfunction appears to be the most prevalent. A novel mechanism is that a subset of SLE patients with cognitive dysfunction have antibodies in the NR2 glutamate receptor. We propose, in a double -blind placebo-controlled trial, to determine whether SLE patients, with or without the NR2 glutamate receptor antibody, have significant improvement using memantine, an inhibitor of the NMDA receptor.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Johns Hopkins University
Collaborator:
Forest Laboratories
Treatments:
Memantine
Criteria
Inclusion Criteria:

- Clinical diagnosis of SLE

- Self-reported cognitive impairment

Exclusion Criteria:

- Age < 18 years.

- History of non-compliance

- Pregnancy

- Liver or renal insufficiency/failure (calculated creatinine clearance < 50 cc/min)

- Severe SLE flare in the last 6 weeks (defined as SLEDAI > 12 points)

- Recent (within 4 weeks) change in any medication relevant to cognitive function,
including prednisone, anti-depressants, medications for insomnia, narcotic
medications, attention deficit disorder medications

- Current alcohol or illicit drug abuse

- Current use of Namenda, Aricept, Provigil