Memantine in Systemic Lupus Erythematosus
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|ClinicalTrials.gov Identifier: NCT00181298|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : March 7, 2008
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Drug: Memantine Drug: Placebo||Not Applicable|
Patients with SLE frequently report cognitive and memory problems and many studies have documented significant cognitive deficits with traditional neuropsychological test batteries. Many traditional neuropsychological tests are unsuitable for repeated measures over short intervals caused by expected improvement due to test-retest or practice effects. We will utilize an automated battery (ANAM) of cognitive function tests at baseline, 6 weeks, and 12 weeks, as the outcome measure.
Betty Diamond M.D. and colleagues demonstrated that a subset of lupus anti-DNA antibodies cross-reacts with the NR2 glutamate receptor in patients with SLE. Glutamate receptors can display altered expression in major psychosis and over-stimulation of NR2 can cause excitotoxic neuron death through excessive entry of calcium into cells. Thus, antibody reactivity with NR2a or NR2b may not only serve as a marker for CNS disease in SLE but may also be neuropathogenic mechanism for some of the non-focal CNS disturbances in SLE.
Memantine is a low- to moderate-affinity, noncompetitive N-methyl-D-asparate (NMDA) receptor that represents the first member of a new class of medications showing clinical benefit and good tolerability in Alzheimer's Disease. Because of our anecdotal experience with some SLE patients with cognitive impairment improving with donepezil therapy, an approved Alzheimer's Disease therapy, and because of the known association of cognitive impairment in SLE with anti-NR2 glutamate (NMDA) receptor antibodies, we hypothesize that memantine will have benefit for cognitive dysfunction in SLE.
We believe that computerized cognitive function batteries (ANAM) can be used in clinical trials of cognitive impairment, with the benefit of efficiency, immediate results, and less patient time. However, because this is the first clinical trial of this kind in SLE, we will also use the formal American College of Rheumatology neuropsychiatric battery, as well
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Memantine in Systemic Lupus Erythematosus|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||May 2007|
|Active Comparator: 1||
Dispensing initially 5 mg. Dose Increased by 5 mg weekly to 20 mg/d final dose by week 4.
Other Name: Namenda
|Placebo Comparator: 2||
Dispensing initially 5 mg. Dose Increased by 5 mg weekly to 20 mg/d final dose by week 4
- Change in ANAM, Version 3.11 [ Time Frame: 12 Weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00181298
|United States, Maryland|
|Johns Hopkins Lupus Center, 1830 East Monument Street, Suite 7500|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Michelle Petri, M.D., M.P.H.||Johns Hopkins University|