Hyperlipidemia and Statin Therapy in Amyotrophic Lateral Sclerosis

The Methodist Hospital Research Institute (TMHRI)

Status: Completed

Conditions: Amyotrophic Lateral Sclerosis

Study type: Observational

Funder types: Other

Identifiers

NCT01592084

IRB(2)0609-0087

Details and patient eligibility

About

The role of hyperlipidemia and lipid lowering therapy (LLT) in Amyotrophic Lateral Sclerosis (ALS) pathophysiology and its impact on disease progression and survival is unclear. The investigators analyzed the correlation between lipid levels with disease progression and survival in ALS patients and the association of LLT with these outcomes.

Enrollment: 267 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A clinical diagnosis of laboratory-supported probable, probable, or definite familial, sporadic ALS, according to a modified El Escorial criteria (ref), by the study investigators

• Time from disease onset is less than three years

  • 18 years of age

• Subjects with diagnosis of hyperlipidemia and/or taking lipid lowering medications will not be excluded from study.

Exclusion criteria

• Requirement for tracheotomy ventilation or non-invasive ventilation for > 23 hours per day
• Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc)
• A clinically significant history of significant medical illness (advanced cancer, chronic inflammatory/infectious conditions, etc) within six months of baseline
• Use of progestins, anabolic steroids, and corticosteroids within 45 days of baseline visit. Therapy is allowed as medically indicated after baseline visit.

Trial design

267 participants in 1 patient group

lipid lowering therapy

Description:

those with lipid lowering therapy those without lipid lowering therapy