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

Official Title: “A Randomized, Double-Blind, Placebo-Controlled, Phase IIa Study to Assess the Short-Term Effects of PRX-03140 Alone and in Combination With Donepezil in Subjects With Mild Alzheimer's Disease.”

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.

Intervention(s) in this Clinical Trial

• Drug: PRX-03140

Primary Measures

• Safety and tolerability of PRX-03140 during 2 weeks of treatment.
• Electroencephalogram (EEG) changes through 14 days of treatment.

Secondary Measures

• Changes in cognition after 2 weeks of treatment.
• Blood concentrations of PRX-03140 and Aricept during 14 days of treatment.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 60 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Epix Pharmaceuticals, Inc. Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00384423

Study ID Number: PRX-CP-018

ClinicalTrials.gov Identifier: NCT00384423

Health Authority: United States: Food and Drug Administration