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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.
 
ClinicalTrials.gov Identifier: NCT00384423
Recruitment Status : Completed
First Posted : October 6, 2006
Last Update Posted : January 30, 2008
Sponsor:
Information provided by:
Epix Pharmaceuticals, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: PRX-03140 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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.
Study Start Date : October 2006
Actual Primary Completion Date : October 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability of PRX-03140 during 2 weeks of treatment.
  2. Electroencephalogram (EEG) changes through 14 days of treatment.

Secondary Outcome Measures :
  1. Changes in cognition after 2 weeks of treatment.
  2. Blood concentrations of PRX-03140 and Aricept during 14 days of treatment.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384423


Locations
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Sponsors and Collaborators
Epix Pharmaceuticals, Inc.
More Information
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ClinicalTrials.gov Identifier: NCT00384423    
Other Study ID Numbers: PRX-CP-018
First Posted: October 6, 2006    Key Record Dates
Last Update Posted: January 30, 2008
Last Verified: January 2008
Keywords provided by Epix Pharmaceuticals, Inc.:
Alzheimer's Disease
AD
PRX-03140
Dementia
 Epix
Predix
Cognition enhancing
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders