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

NCT00672945 | Terminated Phase 2

• 1 other identifier: Protocol 01340-202
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 38

Brief Summary

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Alzheimer's Disease Assessment Scale-Cognitive subscale.

Study Arms (2)

PRX-03140

EXPERIMENTAL

Drug: PRX-03140

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PRX-03140 DRUG

PRX-03140

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* Men or Women with a clinical diagnosis of Probable AD * MMSE score 12 to 22 inclusive * Age \>50 and \<90 years * Received at least 4 months of a stable dose of donepezil 10mg QD for AD * Brain CT or MRI scan Consistent with a primary diagnosis of AD within 24 months * Neurological examination without focal deficits (excluding changes attributable to peripheral nervous system disease, trauma or congenital birth deficits) * No history or evidence of any other CNS disorder that could be interpreted as a cause of dementia * No diagnosis of vascular dementia * No history of significant psychiatric illness such as schizophrenia or bipolar affective disorder. Subjects with major depressive disorder on a stable dose of an antidepressant for \>6 months may be eligible * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Epix Pharmaceuticals, Inc.: lead

Study Sites (38)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

PsyPharma Clinical Research, Inc.

Phoenix, Arizona, 85050, United States

Location

Northwest NeuroSpecialists, PLLC

Tucson, Arizona, 85741, United States

Location

Synergy Clinical Research Center

National City, California, 91950, United States

Location

Pacific Neuroscience Medical Group

Oxnard, California, 93030, United States

Location

California Neuroscience Research Medical Group, Inc.

Sherman Oaks, California, 91403, United States

Location

Torrance Clinical Research

Torrance, California, 90505, United States

Location

Bradenton Research Center

Bradenton, Florida, 34205, United States

Location

Brain Matters Research

Delray Beach, Florida, 33445, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32216, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Compass Research

Orlando, Florida, 32806, United States

Location

Berma Research Group

Plantation, Florida, 33317, United States

Location

Meridien Research

St. Petersburg, Florida, 33709, United States

Location

Stedman Clinical Trials

Tampa, Florida, 33613, United States

Location

Roskamp Institute

Tampa, Florida, 33617, United States

Location

Alexian Brothers Neroscience Institute

Elk Grove Village, Illinois, 60007, United States

Location

Four Rivers Clinical Research

Paducah, Kentucky, 42003, United States

Location

J. Gary Booker, MD

Shreveport, Louisiana, 71104, United States

Location

Maine Neurology

Scarborough, Maine, 04074, United States

Location

The ICPS Group

Norwood, Massachusetts, 02062, United States

Location

Memory Center of America

Long Beach, New Jersey, 07740, United States

Location

Alzheimer's Research Corporation

Paterson, New Jersey, 08759, United States

Location

Global Medical Institutes

Princeton, New Jersey, 08540, United States

Location

Neurological Associates of Albany, P.C.

Albany, New York, 12208, United States

Location

Social Psychiatry Research Institute

Brooklyn, New York, 11235, United States

Location

The Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Behavioral Medical Research of Staten Island

Staten Island, New York, 10305, United States

Location

The Neurological Institute, P.A.

Charlotte, North Carolina, 28204, United States

Location

MedArk

Morgantown, North Carolina, 28655, United States

Location

Neurology and Neuroscience Center of Ohio

Toledo, Ohio, 43623, United States

Location

Tulsa Clinical Research, LLC

Tulsa, Oklahoma, 74104, United States

Location

RI Mood and Memory Research Institute

East Providence, Rhode Island, 02914, United States

Location

Todd Swick, MD, PA

Houston, Texas, 77063, United States

Location

The Memory Clinic

Bennington, Vermont, 05201, United States

Location

University of Vermont

Burlington, Vermont, 05401, United States

Location

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

Norfolk, Virginia, 23507, United States

Location

The Center for Excellence in Aging and Geriatric Health

Williamsburg, Virginia, 23185, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 2, 2008
• First Posted: May 6, 2008
• Study Start: April 1, 2008
• Primary Completion: January 1, 2010
• Last Updated: July 30, 2009

Record last verified: 2009-07

Locations

US (38)