At a glance
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An Open-label Exploratory Study With Memantine: Correlation Between Proton Magnetic Resonance Spectroscopy, Cerebrospinal Fluid Biomarkers, and Cognition in Patients With Mild to Moderate Alzheimer's Disease
In Brief
A Phase 4 clinical trial evaluating memantine for Alzheimer Disease. Completed, enrolled 12 participants across 1 site.
Detailed Summary
We are studying subjects with mild to moderate Alzheimer's disease who have been on a stable dose of any cholinesterase inhibitor \[donepezil (Aricept), rivastigmine (Exelon), or galantamine (Razadyne)\] for at least 3 months, and have not previously taken memantine (Namenda). This is an open-label study, with magnetic resonance spectroscopy (MRS) as the primary outcome measure, along with neuropsychological testing, and optional lumbar puncture, evaluating patients on their stable dose of a cholinesterase inhibitor over 24 weeks, followed by another 24 weeks on memantine in combination with stable dose of cholinesterase inhibitor. The purpose of this study is to characterize the progression of disease using MRS, cerebrospinal fluid (CSF) biomarkers, and cognitive outcome measures, and to determine whether changes in cognitive function on neuropsychological testing are correlated to changes in MR spectroscopic and/or CSF biomarkers.
Study Details
Timeline
Interventions
24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 10 mg orally b.i.d., in addition to their ongoing stable cholinesterase inhibitor treatment