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Completed

NCT Number: NCT00486044

Evaluating Simvastatin's Potential Role in Therapy

The purpose of this study is to see how simvastatin, a cholesterol-lowering drug, affects processes related to the development of Alzheimer's disease, including: 1) levels of a substance called beta-amyloid-42 found in the spinal fluid surrounding the brain, 2) blood flow in the brain, 3) inflammation in the brain, and 4) cognitive function.

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Key information

Conditions

Alzheimer Disease Amyloidosis Brain Diseases Central Nervous System Diseases Dementia Inflammation Mental Disorders Metabolic Diseases Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Tauopathies

Age range

35 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

About this study

Some studies suggest that statin medications, which are a group of cholesterol-lowering medicines, may help prevent Alzheimer's disease. However, this has not been proven in humans. The purpose of this study is to see how simvastatin affects a substance in the spinal fluid around the brain called beta-amyloid-42 which is thought to contribute to Alzheimer's disease. This study also evaluates whether simvastatin improves regional brain blood flow (on magnetic resonance imaging [MRI]), reduces inflammation, and improves cognitive function.

The ESPRIT study was a 9-month randomized, controlled clinical trial that randomized 100 middle-aged adults with a parental history of Alzheimer's disease. Participants were randomized to simvastatin 40 mg for one month then 80 mg daily or matching placebo tablets. Fifty of the ESPRIT subjects participated in the MRI sub-study.

Participants had the following data collected: fasting blood tests (baseline and months 3 and 9), medical history and medication questionnaires (each visit), study medication side effect review (all visits), lumbar puncture procedure (baseline and month 9), memory testing (baseline and months 3 and 9), and MRI (baseline and month 9 in 50 sub-study participants).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 35 to 69
  • Parent with Alzheimer's disease

Exclusion criteria

  • Current use of cholesterol-lowering medication
  • Active liver disease
  • History of adverse reaction to statins
  • Contraindication to lumbar puncture
  • Elevated lab values (creatine kinase and creatinine)
  • Use of medications known to interact with statins
  • History of dementia
  • Currently pregnant or planning to become pregnant
  • Use of large quantities of grapefruit juice (more than 1 quart per day)
  • Current involvement in another investigational drug study
  • Contraindications to MRI (for MRI sub-study)
  • Ethical contraindication to placebo (persons with high vascular risk)

Treatment and study plan

simvastatin

Drug

40 mg tablet each night for one month, then 80 mg for 8 months

Other names: Zocor

Placebo

Drug

Matching tablet each night for 9 months

Primary outcomes

  1. Change in Cerebrospinal Fluid (CSF) Beta-amyloid-42

    Time frame: baseline and 9 months

Secondary outcomes

  1. Changes in Regional Cerebral Blood Flow on MRI

    Time frame: baseline and 9 months

    Mean changes noted in posterior cingulate cortex

  2. Change in Inflammatory Markers

    Time frame: baseline and 9 months

    Change noted in serum high-sensitivity c-reactive protein

  3. Changes in Cognitive Performance

    Time frame: Baseline and 9 months

    Change in Hopkins Verbal Learning Test Delayed Recall

    The Hopkins Verbal Learning Test Delayed Recall score is the raw number of words recalled at Trial 4, adjusted for years of education and age. This is a 12-item word list test.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • American Federation for Aging Research
  • Merck Sharp & Dohme LLC
  • National Institute on Aging (NIA)
  • Paul Beeson Faculty Scholars Program
  • Starr Foundation
  • The Atlantic Philanthropies
  • The John A. Hartford Foundation

Registry information

Official study title

Effect of Statins on Pathobiology of Alzheimer's Disease

Acronym: ESPRIT

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Jun 13, 2007
Registry last updated
Mar 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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