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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PRX-03140
Sponsored by
Epix Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's Disease, AD, PRX-03140, Dementia, Epix, Predix, Cognition enhancing

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • California Clinical Trials Medical Group, Inc
  • Southwest CLinical Research
  • Pacific Research Network, Inc
  • San Francisco Clinical Research Center
  • Torrance Clinical Research
  • Research Center for Clinical Studies
  • Miami Jewish Home and Hospital for the Aged
  • Berma Research
  • Meridien Research
  • Comprehensive NeuroScience, Inc
  • Atlanta Center for Medical Research
  • J. Gary Booker, MD
  • Neuroscience Research of the Berkshires
  • Neurology Specialists
  • Saint Johns Office Building
  • The Clinical Trial Center, LLC
  • Alliance for Neuro Research, LLC

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 4, 2006
Last Updated
January 29, 2008
Sponsor
Epix Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00384423
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Epix Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's Disease, AD, PRX-03140, Dementia, Epix, Predix, Cognition enhancing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
PRX-03140
Primary Outcome Measure Information:
Title
Safety and tolerability of PRX-03140 during 2 weeks of treatment.
Title
Electroencephalogram (EEG) changes through 14 days of treatment.
Secondary Outcome Measure Information:
Title
Changes in cognition after 2 weeks of treatment.
Title
Blood concentrations of PRX-03140 and Aricept during 14 days of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
California Clinical Trials Medical Group, Inc
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Southwest CLinical Research
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Pacific Research Network, Inc
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
San Francisco Clinical Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Torrance Clinical Research
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Research Center for Clinical Studies
City
Darien
State/Province
Connecticut
ZIP/Postal Code
06820
Country
United States
Facility Name
Miami Jewish Home and Hospital for the Aged
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Berma Research
City
Plantation
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
Facility Name
Meridien Research
City
St Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Comprehensive NeuroScience, Inc
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33702
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
J. Gary Booker, MD
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104
Country
United States
Facility Name
Neuroscience Research of the Berkshires
City
Pittsfield
State/Province
Massachusetts
ZIP/Postal Code
01201
Country
United States
Facility Name
Neurology Specialists
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Facility Name
Saint Johns Office Building
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
The Clinical Trial Center, LLC
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Alliance for Neuro Research, LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States

12. IPD Sharing Statement

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

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