Riluzole for Mild Alzheimer's Disease
Riluzole for Mild Alzheimer's Disease
Overall Status:
Recruiting
Brief Description:
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.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
60 Years | 85 Years | Both | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Detailed Description:
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.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 40.7645239, -73.9624327 | Rockefeller University | New York | New York | 10065 | Recruiting |
Lead Sponsor:
| Agency |
|---|
Rockefeller University |
Collaborator Sponsor:
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Ana Pereira, MD | Principal Investigator | Rockefeller University |
Study Contact:
| Name | Phone | |
|---|---|---|
RU Cares | 800-782-2737 |
Locations
ClinicalTrials.gov ID
NCT01703117 (follow link to view full record on ct.gov in new window)
Official Title:
Glutamatergic Dysfunction in Cognitive Aging: Riluzole in Mild Alzheimer's Disease
Study Start Date:
April 2013
Study End Date:
November 2017
Disease Stage:
Early
Enrollment:
48
