Lipitor as a Treatment for Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00024531
First received: September 19, 2001
Last updated: November 8, 2006
Last verified: November 2006
  Purpose

The purpose of this study is to assess the clinical benefit of Lipitor, a cholesterol-lowering drug, in the treatment of Alzheimer's disease.


Condition Intervention Phase
Alzheimer Disease
Drug: Atorvastatin calcium
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effect of the HMG-CoA Reductase Inhibitor Atorvastatin Calcium, Lipitor, in the Treatment of Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Estimated Enrollment: 98
Study Start Date: October 2000
Estimated Study Completion Date: August 2004
Detailed Description:

This study is a phase II, placebo controlled, double-blind, one year trial investigating the effect of HmG-CoA reductase inhibitor atorvastatin calcium in the treatment of persons with possible or probable Alzheimer's disease. Subjects may continue to take stable doses of Aricept and Exelon. Following enrollment, participants will make visits to the study center every three months for blood tests and neuropsychological testing.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prior to participation in this study, each prospective study individual must sign an informed consent form.
  • Diagnosis of probable or possible Alzheimer's disease according to NINDS-ADRDA and DSM-IV criteria.
  • Not actively participating in another clinical drug trial.
  • MMSE range 12-28 at entry.
  • Hachinski Modified Ischemic score < or =4.
  • Accompanied by appropriate caregiver who can aid in administration of medication and make assessments.
  • Good general health as evidenced by physical, neurological and clinical laboratory examination.
  • Education level > or = 9th grade or equivalent.
  • Fluent in the English language.
  • Reliable caregiver.
  • Able to complete neuropsychological tests.
  • Ambulatory.
  • On stable doses of medications for the treatment of non-excluded medical conditions for four weeks prior to screening.
  • Able to participate in all scheduled evaluations.
  • Geriatric Depression Scale < or = 20.
  • Not exceeding 400 IU of Vitamin E for 30 days.
  • For patients currently taking donepezil, they must remain on a stable dose for at least three months. Individuals taking stable doses of other cholinesterase inhibitors can be included, but no study subject may initiate use of any cholinesterase inhibitor after entrance to trial.
  • Individuals of both sexes over 50 years of age will be eligible.

Exclusion criteria:

  • Significant neurological or psychiatric disease other than Alzheimer's disease.
  • Patients with known or suspected Parkinsons's disease or dementia with Lewy bodies.
  • Significant systemic illness (including uncontrolled hypertension) or organ failure.
  • History of mental illness within one year or history of significant untreated cardiac or thromboembolic vascular disease (arrythmias, unstable angina, CVA, deep venous thrombosis, or pulmonary embolus).
  • Current chronic use of anti-cholinergic medications (anti-histamines, and Artane or Cogentin). Stable doses of anxiolytics, sedatives, hypnotics, antipsychotics and SSRI antidepressants are acceptable. The use of any antipsychotics or tricyclic anti-depressants must be reviewed prior to entry.
  • Diagnosis of major depression according to DSM-IV criteria in the last two years.
  • Allergies to atorvastatin or HMG CoA reductase inhibitors.
  • Pregnant women.
  • History of head injury.
  • On a cholesterol lowering drug at time of enrollment.
  • History of significant liver disease and or elevated transaminases.
  • Cholesterol level lower than 90 mg% at initial screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00024531

Locations
United States, Arizona
Sun Health Research Institute
Sun City, Arizona, United States, 85351
Sponsors and Collaborators
Institute for the Study of Aging (ISOA)
Pfizer
Investigators
Principal Investigator: David L Sparks, PhD Sun Health Research Institute
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00024531     History of Changes
Other Study ID Numbers: IA0031
Study First Received: September 19, 2001
Last Updated: November 8, 2006
Health Authority: Unspecified

Keywords provided by National Institute on Aging (NIA):
Alzheimer disease
Cholesterol-lowering drugs

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
Anticholesteremic Agents
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014