CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
Riluzole +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01703117
NCT01703117Phase 2Completed

Glutamatergic Dysfunction in Cognitive Aging: Riluzole in Mild Alzheimer's Disease

Icahn School of Medicine at Mount Sinai·interventional·Posted Oct 10, 2012·Updated Sep 22, 2021

In Brief

A Phase 2 clinical trial evaluating Riluzole and Placebo for Alzheimer's Disease. Completed, enrolled 50 participants across 2 sites.

Detailed Summary

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 slow down neuropathological progression that will lead to widespread irreversible neuronal loss and significant cognitive dysfunction. Riluzole, a glutamate modulator agent, 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 10, 2012
Enrollment StartNov 1, 2013
Primary CompletionMay 26, 2020
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 13.7 years ago

Interventions

Riluzoledrug

20-22 subjects between the ages of 60-85 will receive study drug.

Placebodrug

20-22 subjects between the ages of 60-85 will receive placebo