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A Study of PRX-03140 in Subjects With Alzheimer's Disease Receiving a Stable Dose of Donepezil

This study has been terminated.
Sponsor:
Information provided by:
Epix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00672945
First received: May 2, 2008
Last updated: July 28, 2009
Last verified: July 2009
History of Changes
  Purpose

A randomized placebo-controlled study to evaluate the efficacy of PRX-03140 in subjects with Alzheimer's Disease receiving a stable dose of donepezil. The study consists of a 26-week double-blind treatment period.


Condition Intervention Phase
Alzheimer's Disease
 Drug: PRX-03140
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase 2 Double-Blind Study of PRX-03140 in Subjects With Alzheimer's Disease Receiving a Stable Dose of Donepezil

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Epix Pharmaceuticals, Inc.:

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

Estimated Enrollment: 420
Study Start Date: April 2008
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRX-03140 Drug: PRX-03140
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Men or Women with a clinical diagnosis of Probable AD
  • MMSE score 12 to 22 inclusive
  • Age >50 and <90 years
  • Received at least 4 months of a stable dose of donepezil 10mg QD for AD
  • Brain CT or MRI scan Consistent with a primary diagnosis of AD within 24 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)
  • No history of drug or alcohol abuse
  • No clinically significant laboratory abnormalities or medical history
  • No investigational drug within 30 days of Randomization
  • Cannot receive memantine within 2 months of enrollment
  • No other prescription acetylcholinesterase inhibitors for AD (other than donepezil) within 4 months of enrollment
  • No clinically significant ECG abnormalities or cardiac history
  • No history of uncontrolled seizure disorder within 12 months of enrollment
  • Cannot be taking MAO inhibitors, bupropion,fluoxetine, paroxetine, quinidine
  • No history of malignancy within 3 years of randomization
  • Women cannot be pregnant or breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00672945

  Show 38 Study Locations
Sponsors and Collaborators
Epix Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Elkan R. Gamzu, PhD, EPIX Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00672945     History of Changes
Other Study ID Numbers: Protocol 01340-202
Study First Received: May 2, 2008
Last Updated: July 28, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
 Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013