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

Phase 2

Terminated

• Conditions: Alzheimer's Disease
• Interventions: Drug: Placebo; Drug: PRX-03140; Drug: Donepezil

• Registration Number: NCT00693004
• Lead Sponsor: Epix Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-30
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-28
• Last Update Posted: 2009-07-30
• Primary Completion: 2010-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 236

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
PRX-03140	PRX-03140	-
donepezil	Donepezil	-

Primary Outcome Measures

Name	Time	Method
Alzheimer's Disease Assessment Scale-Cognitive subscale.

Trial Locations

Locations (33)

Barrow Neurological Institute; 🇺🇸 Phoenix, Arizona, United States

PsyPharma Clinical Research, Inc.; 🇺🇸 Phoenix, Arizona, United States

Northwest NeuroSpecialists, PLLC; 🇺🇸 Tucson, Arizona, United States

Synergy Clinical Research Center; 🇺🇸 National City, California, United States

Pacific Neuroscience Medical Group; 🇺🇸 Oxnard, California, United States

California Neuroscience Research Medical Group, Inc.; 🇺🇸 Sherman Oaks, California, United States

Torrance Clinical Research; 🇺🇸 Torrance, California, United States

Bradenton Research Center; 🇺🇸 Bradenton, Florida, United States

Brain Matters Research; 🇺🇸 Delray Beach, Florida, United States

Clinical Neuroscience Solutions, Inc.; 🇺🇸 Jacksonville, Florida, United States

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