Study of PRX-03140 Monotherapy in Subjects With Alzheimer's Disease
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
1 other identifier
interventional
236
1 country
33
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 30, 2008
CompletedFirst Posted
Study publicly available on registry
June 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedJuly 30, 2009
July 1, 2009
1.7 years
May 30, 2008
July 28, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Alzheimer's Disease Assessment Scale-Cognitive subscale.
Study Arms (3)
Placebo
PLACEBO COMPARATORPRX-03140
EXPERIMENTALdonepezil
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
PsyPharma Clinical Research, Inc.
Phoenix, Arizona, 85050, United States
Northwest NeuroSpecialists, PLLC
Tucson, Arizona, 85741-3537, United States
Synergy Clinical Research Center
National City, California, 91950, United States
Pacific Neuroscience Medical Group
Oxnard, California, 93030, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, 91403, United States
Torrance Clinical Research
Torrance, California, 90505, United States
Bradenton Research Center
Bradenton, Florida, 34205, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32216, United States
Compass Research
Orlando, Florida, 32806, United States
Berma Research Group
Plantation, Florida, 33317, United States
Meridien Research
St. Petersburg, Florida, 33709, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
Roskamp Institute
Tampa, Florida, 33617, United States
Four Rivers Clinical Research
Paducah, Kentucky, 42003, United States
J. Gary Booker, MD, APMC
Shreveport, Louisiana, 71104, United States
Maine Neurology
Scarborough, Maine, 04074, United States
The ICPS Group
Norwood, Massachusetts, 02062, United States
Alzheimer's Research Corporation
Paterson, New Jersey, 08759, United States
Global Medical Institutes
Princeton, New Jersey, 08540, United States
Social Psychiatry Research Institute
Brooklyn, New York, 11235, United States
The Mount Sinai Medical Center
New York, New York, 10029, United States
Behavioral Medical Research of Staten Island
Staten Island, New York, 10305, United States
The Neurological Institute, P.A.
Charlotte, North Carolina, 28204, United States
MedArk
Morgantown, North Carolina, 28655, United States
Neurology and Neuroscience Center of Ohio
Toledo, Ohio, 43623, United States
Tulsa Clinical Research, LLC
Tulsa, Oklahoma, 74104, United States
Rhode Island Mood and Memory Research Institute
East Providence, Rhode Island, 02914, United States
Todd Swick, MD, PA
Houston, Texas, 77063, United States
The Memory Clinic
Bennington, Vermont, 05201, United States
The Glennan Center for Geriatrics & Gerontology, Eastern Virginia Medical School
Norfolk, Virginia, 23507, United States
The Center for Excellence in Aging and Geriatric Health
Williamsburg, Virginia, 23185, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 30, 2008
First Posted
June 6, 2008
Study Start
May 1, 2008
Primary Completion
January 1, 2010
Last Updated
July 30, 2009
Record last verified: 2009-07