Memantine in Systemic Lupus Erythematosus

NCT00181298 | Completed

• 1 other identifier: NAM-MD-20
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Systemic Lupus Erythematosus

Keywords

Memantine; SLE; Anti NR2; ANAM; Cognitive functioning

Outcome Measures

Primary Outcomes (1)

• Change in ANAM, Version 3.11

  12 Weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Memantine

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Memantine DRUG

Dispensing initially 5 mg. Dose Increased by 5 mg weekly to 20 mg/d final dose by week 4.

Also known as: Namenda

1

Placebo DRUG

Dispensing initially 5 mg. Dose Increased by 5 mg weekly to 20 mg/d final dose by week 4

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of SLE
• Self-reported cognitive impairment

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Forest Laboratories: collaborator

Study Sites (1)

Johns Hopkins Lupus Center, 1830 East Monument Street, Suite 7500

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Memantine

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Michelle Petri, M.D., M.P.H.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: March 1, 2006
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: March 7, 2008

Record last verified: 2008-03

Locations

US (1)