Lipitor as a Treatment for Alzheimer's Disease

NCT00024531 | Completed Phase 2

• 1 other identifier: IA0031
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

Alzheimer disease; Cholesterol-lowering drugs

Interventions

Atorvastatin calcium DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute for the Study of Aging (ISOA): lead
• Pfizer: collaborator

Study Sites (1)

Sun Health Research Institute

Sun City, Arizona, 85351, United States

Location

Related Publications (6)

• 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.

  PMID: 8744411 BACKGROUND

• 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.

  PMID: 9329686 BACKGROUND

• 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.

  PMID: 10936882 BACKGROUND

• 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.

  PMID: 14501025 BACKGROUND

• 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.

  PMID: 12212783 BACKGROUND

• 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.

  PMID: 15883262 RESULT

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• David L Sparks, PhD

  Sun Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 19, 2001
• First Posted: September 20, 2001
• Study Start: October 1, 2000
• Study Completion: August 1, 2004
• Last Updated: November 9, 2006

Record last verified: 2006-11

Locations

US (1)