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

NCT ID: NCT00384423

Last Updated: 2008-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Brief Summary

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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

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Conditions

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Alzheimer's Disease

Keywords

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Alzheimer's Disease AD PRX-03140 Dementia Epix Predix Cognition enhancing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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PRX-03140

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Epix Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Locations

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California Clinical Trials Medical Group, Inc

Paramount, California, United States

Site Status

Southwest CLinical Research

Rancho Mirage, California, United States

Site Status

Pacific Research Network, Inc

San Diego, California, United States

Site Status

San Francisco Clinical Research Center

San Francisco, California, United States

Site Status

Torrance Clinical Research

Torrance, California, United States

Site Status

Research Center for Clinical Studies

Darien, Connecticut, United States

Site Status

Miami Jewish Home and Hospital for the Aged

Miami, Florida, United States

Site Status

Berma Research

Plantation, Florida, United States

Site Status

Comprehensive NeuroScience, Inc

St. Petersburg, Florida, United States

Site Status

Meridien Research

St. Petersburg, Florida, United States

Site Status

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Site Status

J. Gary Booker, MD

Shreveport, Louisiana, United States

Site Status

Neuroscience Research of the Berkshires

Pittsfield, Massachusetts, United States

Site Status

Neurology Specialists

Dayton, Ohio, United States

Site Status

Saint Johns Office Building

Tulsa, Oklahoma, United States

Site Status

The Clinical Trial Center, LLC

Jenkintown, Pennsylvania, United States

Site Status

Alliance for Neuro Research, LLC

Greenville, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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PRX-CP-018

Identifier Type: -

Identifier Source: org_study_id