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

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

Tracking Information

• First Submitted Date: October 4, 2006
• First Posted Date: October 6, 2006
• Last Update Posted Date: January 30, 2008
• Study Start Date: October 2006
• Actual Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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.
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Alzheimer's Disease
• Intervention: Drug: PRX-03140
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: October 4, 2006): 80
• Original Enrollment: Same as current
• Study Completion Date: Not Provided
• Actual Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00384423
• Other Study ID Numbers: PRX-CP-018
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: Epix Pharmaceuticals, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Epix Pharmaceuticals, Inc.
• Verification Date: January 2008