Study of PRX-03140 Monotherapy in Subjects With Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Official title:

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of PRX-03140 as Monotherapy in Subjects With Alzheimer's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00693004
• Other study ID #: Protocol 03140-203
• Status: Terminated
• Phase: Phase 2
• First received: May 30, 2008
• Last updated: July 28, 2009
• Start date: May 2008

Study information

• Verified date: July 2009
• 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

A randomized placebo-controlled study to evaluate the efficacy of PRX-03140 monotherapy in subjects with Alzheimer's disease. The study consists of a 3-month double-blind treatment period and an optional 3-month extension period.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 236
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

• Men or Women with a clinical diagnosis of Probable AD

• MMSE score 16 to 24 inclusive

• Age >50 and <90 years

• Brain CT or MRI scan Consistent with a primary diagnosis of AD within 12 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)

Exclusion Criteria:

• No history of drug or alcohol abuse

• No clinically significant laboratory abnormalities or medical history

• No investigational drug within 30 days of Randomization

• Intolerance or allergy to cholinesterase inhibitors

• Cannot have been on cholinesterase inhibitors for AD for > 2 years

• If have been on cholinesterase inhibitors for < 2 years, must have been discontinued >= 2 months prior to randomization

• Cannot have received memantine within 2 months

• No clinically significant ECG abnormalities prior to randomization

• No history of uncontrolled seizure disorder within 12 months

• Cannot be taking MAO inhibitors, bupropion,fluoxetine, paroxetine, quinidine

• No history of malignancy within 3 years of randomization

• Women cannot be pregnant or breastfeeding

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• PRX-03140

• Donepezil

• Placebo

Locations

Country	Name	City	State
United States	The Memory Clinic	Bennington	Vermont
United States	Bradenton Research Center	Bradenton	Florida
United States	Social Psychiatry Research Institute	Brooklyn	New York
United States	The Neurological Institute, P.A.	Charlotte	North Carolina
United States	Brain Matters Research	Delray Beach	Florida
United States	Rhode Island Mood and Memory Research Institute	East Providence	Rhode Island
United States	Todd Swick, MD, PA	Houston	Texas
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Alzheimer's Research Corporation	Manchester	New Jersey
United States	MedArk	Morgantown	North Carolina
United States	Synergy Clinical Research Center	National City	California
United States	The Mount Sinai Medical Center	New York	New York
United States	The Glennan Center for Geriatrics & Gerontology, Eastern Virginia Medical School	Norfolk	Virginia
United States	The ICPS Group	Norwood	Massachusetts
United States	Compass Research	Orlando	Florida
United States	Pacific Neuroscience Medical Group	Oxnard	California
United States	Four Rivers Clinical Research	Paducah	Kentucky
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	PsyPharma Clinical Research, Inc.	Phoenix	Arizona
United States	Berma Research Group	Plantation	Florida
United States	Global Medical Institutes	Princeton	New Jersey
United States	Maine Neurology	Scarborough	Maine
United States	California Neuroscience Research Medical Group, Inc.	Sherman Oaks	California
United States	J. Gary Booker, MD, APMC	Shreveport	Louisiana
United States	Meridien Research	St. Petersburg	Florida
United States	Behavioral Medical Research of Staten Island	Staten Island	New York
United States	Roskamp Institute	Tampa	Florida
United States	Stedman Clinical Trials	Tampa	Florida
United States	Neurology and Neuroscience Center of Ohio	Toledo	Ohio
United States	Torrance Clinical Research	Torrance	California
United States	Northwest NeuroSpecialists, PLLC	Tucson	Arizona
United States	Tulsa Clinical Research, LLC	Tulsa	Oklahoma
United States	The Center for Excellence in Aging and Geriatric Health	Williamsburg	Virginia

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	Alzheimer's Disease Assessment Scale-Cognitive subscale.