Overview

This trial is active, not recruiting.

Condition alzheimer's disease
Treatments simvastatin, placebo
Phase phase 2
Sponsor University of Wisconsin, Madison
Start date March 2009
End date September 2013
Trial size 88 participants
Trial identifier NCT00939822, 2015-0038, H-2008-0275, H-2009-0030, RO1-AG031790-01A1

Summary

The purpose of the research is to see how simvastatin affects a substance in the body called beta-amyloid. Beta-amyloid is found in the brain and in the liquid around the brain and spinal cord. High amounts of beta-amyloid may be associated with a greater risk of getting Alzheimer's disease. This study will see if simvastatin can lower the amount of beta-amyloid in the spinal fluid. This study will also see if simvastatin affects memory and thinking, blood flow in the brain, and blood vessel function. The investigators hope that future studies show whether simvastatin might prevent memory loss and decrease the chance of developing Alzheimer's disease.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
40 mg. Simvastatin/day
simvastatin
40 mg Simvastatin/day
(Placebo Comparator)
Matching Placebo
placebo
Matching Placebo

Primary Outcomes

Measure
Changes in cerebrospinal fluid (CSF) beta-amyloid-42 levels as measured by xMAP
time frame: Baseline and month 9

Secondary Outcomes

Measure
Changes in CSF beta-amyloid-40 levels as measured by xMAP
time frame: baseline and month 9
Changes in CSF soluble alpha precursor proteins (sAPP-alpha) and soluble beta precursor proteins (sAPP-beta) as measured by Duplex
time frame: baseline and month 9
Changes in cerebrospinal fluid CSF beta-amyloid-42 levels as measured by Triplex
time frame: baseline and month 9
Changes in CSF total tau (t-tau) and phosphorylated tau (p-tau) as measured by xMAP
time frame: baseline and month 9
Changes in beta-amyloid peptides as measured by surface-enhanced laser desorption ionization - time of flight (SELDI-TOF)
time frame: baseline and month 9

Eligibility Criteria

Male or female participants from 40 years up to 72 years old.

Inclusion Criteria: - Parent diagnosed with Alzheimer's disease - Age 40-72 Exclusion Criteria: - Active liver disease - History of adverse reaction to statins - Contraindication to lumbar puncture - Elevated creatine kinase and creatinine lab values - Use of medications known to interact with statins - History of dementia or mild cognitive impairment - Currently pregnant or planning to become pregnant - Use of large quantities of grapefruit juice (more than 1 quart per day) - Contraindications to MRI (for MRI sub-study) - Currently on cholesterol-lowering medication or use in past 4 months - History of heart attack, heart problems, stroke and/or diabetes - Drinking more than a quart of grapefruit juice per day - Metal implants, or metal debris in body (MRI) - List of medications that interact with simvastatin

Additional Information

Official title Statin Effects on Beta-Amyloid and Cerebral Perfusion in Adults at Risk for AD: "Statins in Healthy, At-Risk Adults: Impact on Amyloid and Regional Perfusion (SHARP)" Study
Principal investigator Cynthia M. Carlsson, MD, MS
Description Studies show that some medicines that lower cholesterol may reduce the risk of developing Alzheimer's disease, but this has not yet been proven in humans. We are looking for individuals to participate in this study to see if a cholesterol-lowering medication, called simvastatin affects blood flow to the brain, blood vessel function and a substance in the spinal fluid related to the changes in Alzheimer's disease. The SHARP study included 88 adults ages 40-72 with parental history of documented Alzheimer's disease. The study had 9 visits over the course of 18 months. Participants had fasting blood tests collected, completed a medical history questionnaire and medication side effect review, underwent lumbar puncture procedure, completed memory testing, and had ultrasound and MRI procedures. Participants were randomly assigned to receive either simvastatin or a placebo each night for 18 months.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.