Study of PRX-03140 Monotherapy in Subjects With Alzheimer's Disease
- Conditions
- Alzheimer's Disease
- Interventions
- Registration Number
- NCT00693004
- Lead Sponsor
- Epix Pharmaceuticals, Inc.
- Brief Summary
A randomized placebo-controlled study to evaluate the efficacy of PRX-03140 monotherapy in subjects with Alzheimer's disease. The study consists of a 3-month double-blind treatment period and an optional 3-month extension period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 236
- Men or Women with a clinical diagnosis of Probable AD
- MMSE score 16 to 24 inclusive
- Age >50 and <90 years
- Brain CT or MRI scan Consistent with a primary diagnosis of AD within 12 months
- Neurological examination without focal deficits (excluding changes attributable to peripheral nervous system disease, trauma or congenital birth deficits)
- No history or evidence of any other CNS disorder that could be interpreted as a cause of dementia
- No diagnosis of vascular dementia
- No history of significant psychiatric illness such as schizophrenia or bipolar affective disorder. Subjects with major depressive disorder on a stable dose of an antidepressant for >6 months may be eligible
- No evidence of the following: current vitamin B12 deficiency, positive syphilis serology, positive HIV test, or abnormalities in thyroid function
- No cognitive rehabilitation within 6 months of the study
- Subject has a regular caregiver willing to attend all study visits
- Signed informed consent by the subject (and legal guardian, if applicable)
- No history of drug or alcohol abuse
- No clinically significant laboratory abnormalities or medical history
- No investigational drug within 30 days of Randomization
- Intolerance or allergy to cholinesterase inhibitors
- Cannot have been on cholinesterase inhibitors for AD for > 2 years
- If have been on cholinesterase inhibitors for < 2 years, must have been discontinued >= 2 months prior to randomization
- Cannot have received memantine within 2 months
- No clinically significant ECG abnormalities prior to randomization
- No history of uncontrolled seizure disorder within 12 months
- Cannot be taking MAO inhibitors, bupropion,fluoxetine, paroxetine, quinidine
- No history of malignancy within 3 years of randomization
- Women cannot be pregnant or breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Placebo Placebo - PRX-03140 PRX-03140 - donepezil Donepezil -
- Primary Outcome Measures
Name Time Method Alzheimer's Disease Assessment Scale-Cognitive subscale.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (33)
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
Meridien Research
🇺🇸St. Petersburg, Florida, United States
Torrance Clinical Research
🇺🇸Torrance, California, United States
Bradenton Research Center
🇺🇸Bradenton, Florida, United States
Northwest NeuroSpecialists, PLLC
🇺🇸Tucson, Arizona, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Jacksonville, Florida, United States
Brain Matters Research
🇺🇸Delray Beach, Florida, United States
Synergy Clinical Research Center
🇺🇸National City, California, United States
Compass Research
🇺🇸Orlando, Florida, United States
PsyPharma Clinical Research, Inc.
🇺🇸Phoenix, Arizona, United States
Berma Research Group
🇺🇸Plantation, Florida, United States
Roskamp Institute
🇺🇸Tampa, Florida, United States
The Mount Sinai Medical Center
🇺🇸New York, New York, United States
Pacific Neuroscience Medical Group
🇺🇸Oxnard, California, United States
California Neuroscience Research Medical Group, Inc.
🇺🇸Sherman Oaks, California, United States
Four Rivers Clinical Research
🇺🇸Paducah, Kentucky, United States
J. Gary Booker, MD, APMC
🇺🇸Shreveport, Louisiana, United States
Global Medical Institutes
🇺🇸Princeton, New Jersey, United States
Social Psychiatry Research Institute
🇺🇸Brooklyn, New York, United States
The ICPS Group
🇺🇸Norwood, Massachusetts, United States
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
Maine Neurology
🇺🇸Scarborough, Maine, United States
Alzheimer's Research Corporation
🇺🇸Manchester, New Jersey, United States
Behavioral Medical Research of Staten Island
🇺🇸Staten Island, New York, United States
The Neurological Institute, P.A.
🇺🇸Charlotte, North Carolina, United States
MedArk
🇺🇸Morgantown, North Carolina, United States
Neurology and Neuroscience Center of Ohio
🇺🇸Toledo, Ohio, United States
Rhode Island Mood and Memory Research Institute
🇺🇸East Providence, Rhode Island, United States
The Memory Clinic
🇺🇸Bennington, Vermont, United States
Tulsa Clinical Research, LLC
🇺🇸Tulsa, Oklahoma, United States
Todd Swick, MD, PA
🇺🇸Houston, Texas, United States
The Center for Excellence in Aging and Geriatric Health
🇺🇸Williamsburg, Virginia, United States
The Glennan Center for Geriatrics & Gerontology, Eastern Virginia Medical School
🇺🇸Norfolk, Virginia, United States