Short Term Effects of PRX-03140 in Patients With Mild Alzheimer's Disease Being Treated With Aricept
- Conditions
- Alzheimer's Disease
- Registration Number
- NCT00384423
- Lead Sponsor
- Epix Pharmaceuticals, Inc.
- Brief Summary
This is a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRX-03140 administered orally once daily for 14 days in subjects with mild Alzheimer's Disease who are using a stable, well-tolerated 10 mg dose of Aricept (donepezil) but continue to experience worsening AD symptoms.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- At least 60 years old.
- On a stable 10 mg dose of Aricept for at least 90 days and able to take it in the morning.
- Diagnosis of probable Alzheimer's Disease.
- Mild dementia.
- You or your authorized representative provide voluntary written informed consent.
- Not pregnant, planning a pregnancy, or capable of becoming pregnant.
- Any other medical condition which, in the opinion of the Investigator, would jeopardize your safety, impact the validity of the study results, or interfere with your ability to complete the study according to the protocol.
- Intolerance to Aricept.
- Dementia other than Alzheimer's type.
- Parkinson's Disease.
- History of seizure or epilepsy.
- History of stroke.
- Participation in another research study within last 30 days.
- Enrollment in any previous research study testing PRX-03140.
- Use of prescription cognitive enhancing medications (except Aricept) or MAO inhibitors within last 4 weeks.
- Use of tobacco products within last 4 weeks.
- Positive blood screen for Hepatitis B surface antigen or Hepatitis C antibody.
- Positive urine screen for alcohol or drugs of abuse or history of drug or alcohol abuse within last 6 months.
- Major surgery within last 4 weeks.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety and tolerability of PRX-03140 during 2 weeks of treatment. Electroencephalogram (EEG) changes through 14 days of treatment.
- Secondary Outcome Measures
Name Time Method Changes in cognition after 2 weeks of treatment. Blood concentrations of PRX-03140 and Aricept during 14 days of treatment.
Trial Locations
- Locations (17)
Southwest CLinical Research
🇺🇸Rancho Mirage, California, United States
Comprehensive NeuroScience, Inc
🇺🇸St. Petersburg, Florida, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Neuroscience Research of the Berkshires
🇺🇸Pittsfield, Massachusetts, United States
Berma Research
🇺🇸Plantation, Florida, United States
Meridien Research
🇺🇸St Petersburg, Florida, United States
Miami Jewish Home and Hospital for the Aged
🇺🇸Miami, Florida, United States
Alliance for Neuro Research, LLC
🇺🇸Greenville, South Carolina, United States
J. Gary Booker, MD
🇺🇸Shreveport, Louisiana, United States
Neurology Specialists
🇺🇸Dayton, Ohio, United States
Research Center for Clinical Studies
🇺🇸Darien, Connecticut, United States
Torrance Clinical Research
🇺🇸Torrance, California, United States
California Clinical Trials Medical Group, Inc
🇺🇸Paramount, California, United States
Pacific Research Network, Inc
🇺🇸San Diego, California, United States
San Francisco Clinical Research Center
🇺🇸San Francisco, California, United States
Saint Johns Office Building
🇺🇸Tulsa, Oklahoma, United States
The Clinical Trial Center, LLC
🇺🇸Jenkintown, Pennsylvania, United States