Hyperlipidemia and Statin Therapy in Amyotrophic Lateral Sclerosis

Cohort Study of the Relationship of Hyperlipidemia and Statin Therapy on Survival and Disease Progresssion in Amyotrophic Lateral Sclerosis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01592084

Enrollment

267

Registered

2012-05-07

Start date

2008-04-30

Completion date

2011-09-30

Last updated

2012-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Keywords

lipid lowering therapy, survival, ALSFRS, age, BMI, weight

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
survial(tracheostomy free,<23 hours on NIPPV, from enrollment)	3years	Death was confirmed from Social Security Death Index or newspaper obituaries. Tracheostomy- ventilation was also considered as an end of the life time point.

Secondary

Measure	Time frame	Description
ALSFRS(measure of disability)	at first evaluation(time 0-T0) to six months (T6)	DeltaFS = (48-ALSFRS at first evaluation )/duration from onset to diagnosis (month) changeFS=(ALSFRS at six months-ALSFRS at first evaluation)/6

Countries

United States

Outcome results