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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00384423
Recruitment Status : Completed
First Posted : October 6, 2006
Last Update Posted : January 30, 2008
Information provided by:
Epix Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE October 4, 2006
First Posted Date  ICMJE October 6, 2006
Last Update Posted Date January 30, 2008
Study Start Date  ICMJE October 2006
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2006)
  • Safety and tolerability of PRX-03140 during 2 weeks of treatment.
  • Electroencephalogram (EEG) changes through 14 days of treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2006)
  • Changes in cognition after 2 weeks of treatment.
  • Blood concentrations of PRX-03140 and Aricept during 14 days of treatment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Short Term Effects of PRX-03140 in Patients With Mild Alzheimer's Disease Being Treated With Aricept
Official Title  ICMJE 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.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE Drug: PRX-03140
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 4, 2006)
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00384423
Other Study ID Numbers  ICMJE PRX-CP-018
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Epix Pharmaceuticals, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Epix Pharmaceuticals, Inc.
Verification Date January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP