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

This study has been terminated.
Sponsor:
Information provided by:
Epix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00693004
First received: May 30, 2008
Last updated: July 28, 2009
Last verified: July 2009
  Purpose

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

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

Estimated Enrollment: 236
Study Start Date: May 2008
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Experimental: PRX-03140 Drug: PRX-03140
Active Comparator: donepezil Drug: Donepezil

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693004

  Show 33 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: NCT00693004     History of Changes
Other Study ID Numbers: Protocol 03140-203
Study First Received: May 30, 2008
Last Updated: July 28, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 21, 2014