Study of PRX-03140 Monotherapy in Subjects With Alzheimer's Disease

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT00693004

Run by

Epix Pharmaceuticals, Inc.

People needed

236

Starts

2008-05-01

Last updated by the study team

2009-07-30

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Barrow Neurological Institute — Phoenix, Arizona, United States
• PsyPharma Clinical Research, Inc. — Phoenix, Arizona, United States
• Northwest NeuroSpecialists, PLLC — Tucson, Arizona, United States
• Synergy Clinical Research Center — National City, California, United States
• Pacific Neuroscience Medical Group — Oxnard, California, United States
• California Neuroscience Research Medical Group, Inc. — Sherman Oaks, California, United States
• Torrance Clinical Research — Torrance, California, United States
• Bradenton Research Center — Bradenton, Florida, United States
• Brain Matters Research — Delray Beach, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Jacksonville, Florida, United States
• Compass Research — Orlando, Florida, United States
• Berma Research Group — Plantation, Florida, United States
• Meridien Research — St. Petersburg, Florida, United States
• Stedman Clinical Trials — Tampa, Florida, United States
• Roskamp Institute — Tampa, Florida, United States
• Four Rivers Clinical Research — Paducah, Kentucky, United States
• J. Gary Booker, MD, APMC — Shreveport, Louisiana, United States
• Maine Neurology — Scarborough, Maine, United States
• The ICPS Group — Norwood, Massachusetts, United States
• Alzheimer's Research Corporation — Paterson, New Jersey, United States
• Global Medical Institutes — Princeton, New Jersey, United States
• Social Psychiatry Research Institute — Brooklyn, New York, United States
• The Mount Sinai Medical Center — New York, New York, United States
• Behavioral Medical Research of Staten Island — Staten Island, New York, United States
• The Neurological Institute, P.A. — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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