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Study of PRX-03140 Monotherapy in Subjects With Alzheimer's Disease
This study is currently recruiting participants.
Verified by Epix Pharmaceuticals, Inc., January 2009
Sponsored by: Epix Pharmaceuticals, Inc.
Information provided by: Epix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00693004
  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 II

Genetics Home Reference related topics: Alzheimer disease
MedlinePlus related topics: Alzheimer's Disease
Drug Information available for: Donepezil E 2020
U.S. FDA Resources
Study Type: Interventional
Study Design: 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

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: Placebo Comparator Drug: Placebo
PRX-03140: Experimental Drug: PRX-03140
donepezil: Active Comparator 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 > 1 month
  • If have been on cholinesterase inhibitors for < 1 month, must have been discontinued >= 2 months prior to screening
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00693004

Contacts
Contact: Julia Kazakin, MD 781-761-7646 jkazakin@epixpharma.com

  Show 31 Study Locations
Sponsors and Collaborators
Epix Pharmaceuticals, Inc.
  More Information

Responsible Party: EPIX Pharmaceuticals, Inc. ( Elkan R. Gamzu, PhD )
Study ID Numbers: Protocol 03140-203
Study First Received: May 30, 2008
Last Updated: January 5, 2009
ClinicalTrials.gov Identifier: NCT00693004  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on January 16, 2009