Clinical trial NCT00693004: Study of PRX-03140 Monotherapy in Subjects With Alzheimer's Disease
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: Epix Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-06
Enrollment: 236
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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