A Study of PRX-03140 in Subjects With Alzheimer's Disease Receiving a Stable Dose of Donepezil

NCT ID: NCT00672945

Last Updated: 2009-07-30

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Brief Summary

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A randomized placebo-controlled study to evaluate the efficacy of PRX-03140 in subjects with Alzheimer's Disease receiving a stable dose of donepezil. The study consists of a 26-week double-blind treatment period.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Primary Study Purpose

TREATMENT

Study Groups

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PRX-03140

Group Type EXPERIMENTAL

PRX-03140

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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PRX-03140

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* No evidence of the following: current vitamin B12 deficiency, positive syphilis serology, positive HIV test, or abnormalities in thyroid function
* No cognitive rehabilitation within 6 months of the study
* Subject has a regular caregiver willing to attend all study visits
* Signed informed consent by the subject (and legal guardian, if applicable)
* No history of drug or alcohol abuse
* No clinically significant laboratory abnormalities or medical history
* No investigational drug within 30 days of Randomization
* Cannot receive memantine within 2 months of enrollment
* No other prescription acetylcholinesterase inhibitors for AD (other than donepezil) within 4 months of enrollment
* No clinically significant ECG abnormalities or cardiac history
* No history of uncontrolled seizure disorder within 12 months of enrollment
* Cannot be taking MAO inhibitors, bupropion,fluoxetine, paroxetine, quinidine
* No history of malignancy within 3 years of randomization
* Women cannot be pregnant or breastfeeding
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Epix Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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EPIX Pharmaceuticals, Inc

Locations

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Barrow Neurological Institute

Phoenix, Arizona, United States

Site Status

PsyPharma Clinical Research, Inc.

Phoenix, Arizona, United States

Site Status

Northwest NeuroSpecialists, PLLC

Tucson, Arizona, United States

Site Status

Synergy Clinical Research Center

National City, California, United States

Site Status

Pacific Neuroscience Medical Group

Oxnard, California, United States

Site Status

California Neuroscience Research Medical Group, Inc.

Sherman Oaks, California, United States

Site Status

Torrance Clinical Research

Torrance, California, United States

Site Status

Bradenton Research Center

Bradenton, Florida, United States

Site Status

Brain Matters Research

Delray Beach, Florida, United States

Site Status

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, United States

Site Status

Renstar Medical Research

Ocala, Florida, United States

Site Status

Compass Research

Orlando, Florida, United States

Site Status

Berma Research Group

Plantation, Florida, United States

Site Status

Meridien Research

St. Petersburg, Florida, United States

Site Status

Stedman Clinical Trials

Tampa, Florida, United States

Site Status

Roskamp Institute

Tampa, Florida, United States

Site Status

Alexian Brothers Neroscience Institute

Elk Grove Village, Illinois, United States

Site Status

Four Rivers Clinical Research

Paducah, Kentucky, United States

Site Status

J. Gary Booker, MD

Shreveport, Louisiana, United States

Site Status

Maine Neurology

Scarborough, Maine, United States

Site Status

The ICPS Group

Norwood, Massachusetts, United States

Site Status

Memory Center of America

Long Beach, New Jersey, United States

Site Status

Alzheimer's Research Corporation

Paterson, New Jersey, United States

Site Status

Global Medical Institutes

Princeton, New Jersey, United States

Site Status

Neurological Associates of Albany, P.C.

Albany, New York, United States

Site Status

Social Psychiatry Research Institute

Brooklyn, New York, United States

Site Status

The Mount Sinai Medical Center

New York, New York, United States

Site Status

Behavioral Medical Research of Staten Island

Staten Island, New York, United States

Site Status

The Neurological Institute, P.A.

Charlotte, North Carolina, United States

Site Status

MedArk

Morgantown, North Carolina, United States

Site Status

Neurology and Neuroscience Center of Ohio

Toledo, Ohio, United States

Site Status

Tulsa Clinical Research, LLC

Tulsa, Oklahoma, United States

Site Status

RI Mood and Memory Research Institute

East Providence, Rhode Island, United States

Site Status

Todd Swick, MD, PA

Houston, Texas, United States

Site Status

The Memory Clinic

Bennington, Vermont, United States

Site Status

University of Vermont

Burlington, Vermont, United States

Site Status

The Glennan Center for Geriatrics & Gerontology, Eastern Virginia Medical School

Norfolk, Virginia, United States

Site Status

The Center for Excellence in Aging and Geriatric Health

Williamsburg, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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Protocol 01340-202

Identifier Type: -

Identifier Source: org_study_id