Studies have shown evidence of inflammation in the spinal cords of ALS patients suggesting that motor neuron survival may be influenced by the components of the immune system.

Atorvastatin (Lipitor) has been shown to have novel anti-inflammatory properties in the central nervous system. This suggests that Atorvastatin (Lipitor®) may have the ability to alter the course of ALS.

The primary purpose of this study is to determine the efficacy of Lipitor in subjects with ALS. Efficacy will be determined by the change in rate of progression as measured by manual muscle testing and ALSFRS-R, a questionnaire that asks questions about your ability to perform certain activities of daily living.

The study is double-blind, randomized and placebo-controlled. This means that neither participants nor investigators will know who is taking Lipitor and who is taking a placebo (inert substance that looks like the study drug). Participants will be randomly assigned to the Lipitor group or the placebo group.

Each participant will be in the study for one year and will be required to make seven visits to Methodist Neurological Institute in Houston. Visits will include muscle testing, functional assessments, pulmonary function tests, a blood draw and medical questionnaires.

There is no cost for participating in this study and subjects will not receive any compensation for expenses such as parking.

The primary investigator is Ericka P. Simpson, M.D.  

Inclusion Criteria

Participants must

• have a diagnosis of ALS
• have had ALS for three or fewer years
• have a forced vital capacity (FVC, a respiratory measurement) of at least 50 percent of normal
• have an Appel ALS score (objective grading scale that assesses disease severity) of less than 100

Exclusion Criteria

Participants must not

• have a history of high cholesterol
• be currently taking a cholesterol-lowering medication