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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00693004
Recruitment Status : Terminated
First Posted : June 6, 2008
Last Update Posted : July 30, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: PRX-03140 Drug: Donepezil Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 236 participants
Primary Purpose: Treatment
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 Start Date : May 2008
Estimated Primary Completion Date : January 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Donepezil

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Experimental: PRX-03140 Drug: PRX-03140
Active Comparator: donepezil Drug: Donepezil

Primary Outcome Measures :
  1. Alzheimer's Disease Assessment Scale-Cognitive subscale.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00693004

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Sponsors and Collaborators
Epix Pharmaceuticals, Inc.
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Responsible Party: Elkan R. Gamzu, PhD, EPIX Pharmaceuticals, Inc. Identifier: NCT00693004    
Other Study ID Numbers: Protocol 03140-203
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: July 30, 2009
Last Verified: July 2009
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents