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

Alzheimer's Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00384423
• Other study ID #: PRX-CP-018
• Status: Completed
• Phase: Phase 2
• First received: October 4, 2006
• Last updated: January 29, 2008
• Start date: October 2006

Study information

• Verified date: January 2008
• Source: Epix Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• PRX-03140

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Epix Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of PRX-03140 during 2 weeks of treatment.
Primary	Electroencephalogram (EEG) changes through 14 days of treatment.
Secondary	Changes in cognition after 2 weeks of treatment.
Secondary	Blood concentrations of PRX-03140 and Aricept during 14 days of treatment.