Riluzole in Mild Alzheimer's Disease
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Glutamatergic Dysfunction in Cognitive Aging: Riluzole in Mild Alzheimer's Disease|
- Imaging Biomarkers N-acetylaspartate (NAA) and FDG-PET values in regions of interest [ Time Frame: Change from baseline at 6 months ] [ Designated as safety issue: No ]To determine if after administration of the drug riluzole over 6 months, patients with mild Alzheimer's disease will have in the hippocampus and prefrontal cortex, less decline in the levels of N-acetylaspartate (NAA), a neuronal viability marker (obtained through Magnetic Resonance Spectroscopy-MRS) in comparison to the control group, and a less prominent decline in cerebral metabolism in the regions of interest affected in mild Alzheimer's disease in FDG-PET as compared to the control group.
- Cognitive function (neuropsychological tests); Glutamate levels obtained through MRS [ Time Frame: Change from baseline at 3 and 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||November 2017|
|Estimated Primary Completion Date:||November 2017 (Final data collection date for primary outcome measure)|
Experimental: age matched cohort 60-85 years old
24 subjects between the ages of 60-85 will receive riluzole
24 subjects between the ages of 60-85 will receive study drug.
Other Name: no other names
Placebo Comparator: 24 subjects between 60-85 years old
24 subjects between 60-85 will receive placebo
24 subjects between the ages of 60-85 will receive placebo
Other Name: no other names
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01703117
|Contact: Ana Pereira, MD||212 firstname.lastname@example.org|
|United States, New York|
|The Rockefeller University||Recruiting|
|New York, New York, United States, 10065|
|Contact: RU Cares 800-782-2737 RUCares@rockefeller.edu|
|Principal Investigator:||Ana Pereira, MD||Instructor, Clinical Research Investigator|