- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00024531
Lipitor as a Treatment for Alzheimer's Disease
November 8, 2006 updated by: Institute for the Study of Aging (ISOA)
Effect of the HMG-CoA Reductase Inhibitor Atorvastatin Calcium, Lipitor, in the Treatment of Alzheimer's Disease
The purpose of this study is to assess the clinical benefit of Lipitor, a cholesterol-lowering drug, in the treatment of Alzheimer's disease.
Study Overview
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.
Study Type
Interventional
Enrollment
98
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Sun City, Arizona, United States, 85351
- Sun Health Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: David L Sparks, PhD, Sun Health Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sparks DL. Intraneuronal beta-amyloid immunoreactivity in the CNS. Neurobiol Aging. 1996 Mar-Apr;17(2):291-9. doi: 10.1016/0197-4580(95)02067-5.
- Sparks DL. Coronary artery disease, hypertension, ApoE, and cholesterol: a link to Alzheimer's disease? Ann N Y Acad Sci. 1997 Sep 26;826:128-46. doi: 10.1111/j.1749-6632.1997.tb48466.x.
- Sparks DL, Martin TA, Gross DR, Hunsaker JC 3rd. Link between heart disease, cholesterol, and Alzheimer's disease: a review. Microsc Res Tech. 2000 Aug 15;50(4):287-90. doi: 10.1002/1097-0029(20000815)50:43.0.CO;2-L.
- Sparks DL, Lopez J, Connor D, Sabbagh M, Seward J, Browne P; Alzheimer's Disease Cholesterol-Lowering Treatment Team. A position paper: based on observational data indicating an increased rate of altered blood chemistry requiring withdrawal from the Alzheimer's Disease Cholesterol-Lowering Treatment Trial (ADCLT). J Mol Neurosci. 2003;20(3):407-10. doi: 10.1385/JMN:20:3:407.
- Sparks DL, Connor DJ, Browne P, Sabbagh MN; AD Cholesterol-Lowering Treatment Trial Team. Should the guidelines for monitoring serum cholesterol levels in the elderly be re-evaluated? J Mol Neurosci. 2002 Aug-Oct;19(1-2):209-12. doi: 10.1007/s12031-002-0035-1.
- Sparks DL, Sabbagh MN, Connor DJ, Lopez J, Launer LJ, Browne P, Wasser D, Johnson-Traver S, Lochhead J, Ziolwolski C. Atorvastatin for the treatment of mild to moderate Alzheimer disease: preliminary results. Arch Neurol. 2005 May;62(5):753-7. doi: 10.1001/archneur.62.5.753.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2000
Study Completion
August 1, 2004
Study Registration Dates
First Submitted
September 19, 2001
First Submitted That Met QC Criteria
September 19, 2001
First Posted (Estimate)
September 20, 2001
Study Record Updates
Last Update Posted (Estimate)
November 9, 2006
Last Update Submitted That Met QC Criteria
November 8, 2006
Last Verified
November 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Alzheimer Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Calcium-Regulating Hormones and Agents
- Atorvastatin
- Calcium
Other Study ID Numbers
- IA0031
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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