Short Term Effects of PRX-03140 in Patients With Mild Alzheimer's Disease Being Treated With Aricept

Completed · Phase 2

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT00384423

Run by

Epix Pharmaceuticals, Inc.

People needed

80

Starts

2006-10-01

Last updated by the study team

2008-01-30

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• California Clinical Trials Medical Group, Inc — Paramount, California, United States
• Southwest CLinical Research — Rancho Mirage, California, United States
• Pacific Research Network, Inc — San Diego, California, United States
• San Francisco Clinical Research Center — San Francisco, California, United States
• Torrance Clinical Research — Torrance, California, United States
• Research Center for Clinical Studies — Darien, Connecticut, United States
• Miami Jewish Home and Hospital for the Aged — Miami, Florida, United States
• Berma Research — Plantation, Florida, United States
• Comprehensive NeuroScience, Inc — St. Petersburg, Florida, United States
• Meridien Research — St. Petersburg, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• J. Gary Booker, MD — Shreveport, Louisiana, United States
• Neuroscience Research of the Berkshires — Pittsfield, Massachusetts, United States
• Neurology Specialists — Dayton, Ohio, United States
• Saint Johns Office Building — Tulsa, Oklahoma, United States
• The Clinical Trial Center, LLC — Jenkintown, Pennsylvania, United States
• Alliance for Neuro Research, LLC — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

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