Last updated on March 2019

Riluzole in Mild Alzheimer's Disease

Brief description of study

Cognitive aging is a major source of disability in an increasingly aging population. The paucity of effective treatments for cognitive aging disorders, and most importantly in Alzheimer's disease instigates a need for further research into novel therapeutic possibilities. Alzheimer's disease is the most common neurodegenerative disorder and its prevalence steeply increases. Glutamate-mediated excitotoxicity in neuropsychiatric disorders and in particular in Alzheimer's disease has been shown to cause significant cerebral damage. Early effective therapeutic intervention in Alzheimer's disease is critical in order to prevent or at least retard neuropathological progression that will lead to widespread irreversible neuronal loss and significant cognitive dysfunction. Riluzole, a glutamate modulator agent that is a proven safe medication and has not yet been used in cognitive aging disorders, will be tested in mild Alzheimer's disease patients. Cognitive functional changes along with two established in vivo biomarkers, namely, Magnetic Resonance Spectroscopy (MRS) and Fluorodeoxyglucose (18F) positron emission tomography (FDG-PET) will be evaluated.

Detailed Study Description

A double-blinded, randomized, placebo-controlled study will be performed. Forty-eight individuals with a diagnosis of mild Alzheimer's disease between 60-85 years old will complete the study. There will be two cohorts of 60-75 and 75-85 years old that will be age-matched. All forty-eight individuals will have been on donepezil, which is FDA approved for the treatment of Alzheimer's disease, at a dose of 5mg or 10mg per day for at least 3 months prior to consenting and will remain on the drug throughout this study. Twenty-four mild Alzheimer's disease patients will receive riluzole and another 24 will receive a placebo (the placebo tablets will be generated at the Rockefeller University's pharmacy by the research pharmacist). All patients will have a neurological evaluation and neuropsychological tests performed to confirm that they meet criteria for probable Alzheimer's disease set out by the National Institute on Aging - Alzheimer's disease Association that recently revisited the NINCDS-ADRDA criteria and to have mild Alzheimer's disease.

Clinical Study Identifier: NCT01703117

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The Rockefeller University

New York, NY United States
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