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(APE-0792) Riluzole in Mild Alzheimers Disease

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Glutamatergic Dysfunction in Cognitive Aging: Riluzole in Mild Alzheimers Disease

Principal Investigator:
Anna Pereira


Contact Information:
Clinical Research Support Office The Rockefeller University
1230 York Ave
New York, NY 10065
Telephone: 1-800-RUCARES
Enrollment Status:
Open to Enrollment

Brief Summary of Protocol:
Alzheimer's disease (AD) is the most common cause of dementia. Alzheimer's affects the brain, causing memory problems that progress overtime. Glutamate is a chemical in the brain that is normally involved in sending signals between brain cells. However, when there is too much glutamate, it can cause irreversible loss of neurons in the brain. We think this happens in patients with Alzheimer's disease. We are conducting a research study to test whether a new medication, riluzole (Rilutek), can help people with mild Alzheimer's Disease. We really do not know whether it will help; that is why this is a research study. In order to test the new medication, some patients will be given the medication, and some will receive a 'placebo'. Neither the patients nor the researchers will know which pill a particular patient gets. In order to qualify for the study, patients must have been diagnosed with mild Alzheimer's Disease and must be currently taking the drug donepezil (Aricept®) or rivastigmine (Exelon®) or galantamine (Razadyne®). Patients who agree to enroll in the research study, will be randomly assigned to either receive the study drug, riluzole (Rilutek) or a placebo. The study medication, Riluzole, is an FDA approved medication that affects glutamate levels, and has been proved to be helpful in patients who suffer from another neurologic disorder, Amyotrophic Lateral Sclerosis (ALS), also called Lou Gehrig's disease. In order to evaluate how Rilizole, or the sugar pill, are affecting the brain, we will scan your brain using 2 special types of brain imaging, called Magnetic Resonance Spectroscopy (MRS) and Positron Emission Tomography (FDG-PET). If you participate, the study will last about 6 months and will require monthly visits.

Detailed Description of Protocol:

What specifically makes a person eligible for the study?
You may be eligible to enter this study:

1. Male or female; 60 - 85 years old with mild Alzheimers disease determined after neurological and neuropsychological evaluation following the National Institute on Aging – Alzheimers disease Association criteria. 2. Must be on donepezil (Aricept®) or rivastigmine (Exelon®) or galantamine (Razadyne®) 3. Must be fluent in English 4. The subject will appoint or have previously appointed a health care proxy specifically designated for research consent and that this be documented



Children permitted to participate:

Potential Benefits.....
This treatment may be beneficial to patients with Alzheimers disease, however this has not been proven and this is the purpose of this study.

Compensation is provided.