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Riluzole for Mild Alzheimer's Disease

Recruiting

Riluzole, a drug used to slow down the progress of amyotrophic lateral sclerosis (ALS), will be tested in people with mild Alzheimer's disease. Cognitive functional changes and specific imaging biomarkers will be evaluated.

Minimum Age Maximum Age Gender Healthy Volunteers
60 Years 85 Years Both No
April 2013
November 2018
48

  • Diagnosis of mild Alzheimer's disease, determined after neurological and neuropsychological evaluation following the National Institute on Aging-Alzheimer's Association criteria
  • Clinical Dementia Rating Scale (CDR) score of 0.5 or 1; Mini-Mental State Examination (MMSS) score between 19 and 27
  • Taking donepezil (Aricept®) at a consistent dose of 5 mg or 10 mg per day for at least 3 months
  • Fluent in English
  • Appointment of a health care proxy specifically designated for research consent

  • Moderate to severe Alzheimer's disease or other dementias, as determined by neuropsychological testing and neurological evaluation
  • Previous treatment with riluzole
  • Contraindication to MRI, such as severe claustrophobia, metal implants, shunts, pacemaker, joint implants, or metal valves
  • Currently taking medications with evidence of glutamatergic activity or effects on brain glutamate levels, such as: memantine, lamotrigine, lithium, opiates, bupropion, psychostimulants such as amphetamines and methylphenidates, tricyclic antidepressants, and benzodiazepines; may be allowed at discretion of study investigators
  • Currently using any of these illicit drugs: cocaine, MDMA ("ecstasy"), or heroin/other opioids; history of drug or alcohol abuse within the past 5 years
  • Serum creatinine level >1.5 times the upper limit of normal; abnormal liver function test greater than twice the upper limit of normal for alanine aminotranferase (ALT) or aspartate aminotransferase (AST); bilirubin >1.5 times the upper limit of normal
  • History of brain disease, including Parkinson's disease, severe brain trauma, seizures, stroke, clinically significant lacunar infarct in a region important for cognition, multiple lacunes or a cortical infarct or focal lesions of clinical significance, multiple sclerosis, mental retardation, normal pressure hydrocephalus, central nervous system tumor, Huntington's disease, subdural hematoma, or other serious neurological disorder
  • Uncontrolled diabetes mellitus (Hba1c higher than 7) or chronically uncontrolled hypertension
  • Prohibited medications: Namenda® (memantine) for at least 5 months; donepezil for more than 5 years; drugs that may cause liver toxicity, such as allopurinol, methyldopa and sulfasalazine; if taking, must discontinue Exelon® (rivastigmine) or Razadyne® (galantamine) prior to entering trial
  • Unstable, serious medical condition, including but not limited to: myocardial infarction, coronary artery disease requiring coronary bypass surgery, unstable angina, clinically evident congestive heart failure within the past 6 months
  • Current smoker or user of nicotine-containing products for the past 2 months
  • Current major depression; significant neuropsychiatric illnesses such as bipolar disorder, schizophrenia, moderate-severe anxiety, vascular dementia, Creutzfeldt-Jakob dementia, or HIV dementia
  • Participation in any investigational or marketed drug or device trial within 30 days prior to screening
  • Weight of more than 300 pounds
  • Lactose intolerance

In this Phase II trial, 48 older adults with mild Alzheimer's disease will take either riluzole or a placebo. Riluzole is a medication (a tablet taken by mouth) with neuroprotective properties that affects glutamate, a nerve-cell messenger. It is used to slow down the progress of ALS but is not approved to treat Alzheimer's. Participants will undergo brain scans and other tests to gauge the drug's impact on the brain and cognitive functioning.

Name City State Zip Status Primary Contact
The Rockefeller University
New York New York 10065 Recruiting RU Cares
800-782-2737
RUCares@rockefeller.edu

Rockefeller University

Name Role Affiliation
Ana Pereira, MD Principal Investigator Rockefeller University

Name Phone Email
Ana Pereira, MD 212-327-8622 apereira@rockefeller.edu

NCT01703117

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