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Lipitor as a Treatment for Alzheimer's Disease

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Atorvastatin calcium
Sponsored by
Institute for the Study of Aging (ISOA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer disease, Cholesterol-lowering drugs

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sun Health Research Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 19, 2001
Last Updated
November 8, 2006
Sponsor
Institute for the Study of Aging (ISOA)
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00024531
Brief Title
Lipitor as a Treatment for Alzheimer's Disease
Official Title
Effect of the HMG-CoA Reductase Inhibitor Atorvastatin Calcium, Lipitor, in the Treatment of Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Institute for the Study of Aging (ISOA)
Collaborators
Pfizer

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer disease, Cholesterol-lowering drugs

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Allocation
Randomized
Enrollment
98 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Atorvastatin calcium

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David L Sparks, PhD
Organizational Affiliation
Sun Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Health Research Institute
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8744411
Citation
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.
Results Reference
background
PubMed Identifier
9329686
Citation
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.
Results Reference
background
PubMed Identifier
10936882
Citation
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.
Results Reference
background
PubMed Identifier
14501025
Citation
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.
Results Reference
background
PubMed Identifier
12212783
Citation
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.
Results Reference
background
PubMed Identifier
15883262
Citation
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.
Results Reference
result

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Lipitor as a Treatment for Alzheimer's Disease

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