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To Evaluate the Safety and Effectiveness of Atorvastatin Plus a Cholinesterase Inhibitor in AD Patients.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00151502
First Posted: September 9, 2005
Last Update Posted: July 11, 2008
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.
Information provided by:
Pfizer
  Purpose
The purpose of this study is to find out if atovastatin, when taken with a cholinesterase inhibitor, is effective for treating Alzheimer's disease.

Condition Intervention Phase
Alzheimer's Disease Drug: Atorvastatin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: An 80-Week, Randomized, Multi-Center, Parallel-Group, Double-Blind Study of the Efficacy and Safety of Atorvastatin 80 MG Plus an Acetylcholinesterase Inhibitor Versus an Acetylcholinesterase Inhibitor Alone in the Treatment of Mild to Moderate Alzheimer's Disease.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • If the results of this study demonstrate efficacy and lead to the approval by the FDA of atorvastatin for use in humans for the treatment of Alzheimer's disease, this would be available as an additional treatment option for patients.

Secondary Outcome Measures:
  • If the results of this study demonstrate efficacy and lead to the approval by the Food and Drug Administration of atorvastatin for use in humans, subject activities of daily living are being assessed.

Estimated Enrollment: 600
Study Start Date: November 2002
Study Completion Date: July 2007
  Eligibility

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.


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

Inclusion Criteria:

  • Diagnostic evidence of probable Alzheimer's disease consistent with NINCDS/ADRDA and DSM IV criteria.
  • Subject's Mini-Mental Status Examination Score (MMSE) must be in the range of 13 - 25 (inclusive) at Screening.

Exclusion Criteria:

  • Subjects with dementia due to causes other than Alzheimer's disease.
  • Any condition, which, in the investigator's judgment might increase the risk to the subject or decrease the reliability of the data required to meet the objectives of the study.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00151502


  Show 99 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00151502     History of Changes
Other Study ID Numbers: A2581078
First Submitted: September 6, 2005
First Posted: September 9, 2005
Last Update Posted: July 11, 2008
Last Verified: July 2008

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Atorvastatin Calcium
Cholinesterase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs