Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00181298
Status:
COMPLETED
Last Update Posted:
2008-03-07
First Post:
2005-09-13
Brief Title:
Memantine in Systemic Lupus Erythematosus
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Memantine in Systemic Lupus Erythematosus
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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 MD 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 Alzheimers Disease Because of our anecdotal experience with some SLE patients with cognitive impairment improving with donepezil therapy an approved Alzheimers 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
Betty Diamond MD 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 Alzheimers Disease Because of our anecdotal experience with some SLE patients with cognitive impairment improving with donepezil therapy an approved Alzheimers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None