Effects of Simvastatin on Biomarkers

Phase 4

Completed

Conditions: Alzheimer's Disease

Interventions: Drug: Placebo
Drug: Simvastatin

Registration Number: NCT01142336

Lead Sponsor: University of Washington

Brief Summary: A year-long randomized, double-blind, placebo-controlled trial of simvastatin to see if it produces beneficial changes in cerebral spinal fluid proteins associated with Alzheimer's disease.

Detailed Description: The purpose of this study is to see if a drug called simvastatin (brand name Zocor) beneficially affects the level of certain molecules (such as proteins) in the spinal fluid of people. The molecules the investigators are measuring are thought to be important in the development of Alzheimer's disease (AD), and the investigators are testing whether simvastatin can change proteins to a level that is associated with a reduced risk for AD.

Simvastatin has been approved by the United States Food and Drug Administration (FDA) for the treatment of high cholesterol and to reduce the risk of coronary artery disease. It is an investigational drug in this study.

Participants will be randomly assigned to Placebo or Simvastatin. The investigators and the participant will be blinded. Randomization will be stratified by age and gender.

This study is being funded by the National Institute on Aging. The investigators will take part in this study at the VA Puget Sound Health Care System.

This study will last up to 1 year. Participants will be asked to come to the VA in Seattle a total of 9 times, 2 of those times will be for lumbar punctures (also known as a spinal tap).

The investigators would also like to ask a person who knows the participant well (such as a spouse, child, sibling, or good friend) some questions about the participant's health, memory, mood and behavior, and abilities to do daily tasks at the beginning and the end of the study.

Participants must be cognitively normal, healthy, willing to have a lumbar puncture, and not need or take any medications to control cholesterol.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 49

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo 1 tablet qHS for 1 year
Simvastatin	Simvastatin	Simvastatin 40mg qHS for 1 year

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Aβ42 in Cerebrospinal Fluid (CSF) at 1 Year	1-year change of CSF Aβ42 from baseline	CSF Aβ42 concentration were measured at baseline and after 1-year intervention.
Change From Baseline in CSF Total Tau at 1 Year	1-yr change	CSF total tau was measured at baseline and after 1-year of intervention
Change From Baseline in CSF ptau181 at 1 Year	1-year change from baseline	ptau 181 measured in CSF at baseline and after 1-year intervention