Hyperlipidemia and Statin Therapy in Amyotrophic Lateral Sclerosis

NCT01592084 | Completed

• 1 other identifier: IRB(2)0609-0087
• Study Type: observational
• Target: 267
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• survial(tracheostomy free,<23 hours on NIPPV, from enrollment)

  Death was confirmed from Social Security Death Index or newspaper obituaries. Tracheostomy- ventilation was also considered as an end of the life time point.

  3years

Secondary Outcomes (1)

• ALSFRS(measure of disability)

  at first evaluation(time 0-T0) to six months (T6)

Study Arms (1)

lipid lowering therapy

those with lipid lowering therapy those without lipid lowering therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

the Methodist Neurological Institute

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

the Methodist Neurological Institute

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Body Weight

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ericka P Simpson, M.D

  the Methodist Neurological Institute

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Study Record Dates

• First Submitted: April 13, 2012
• First Posted: May 7, 2012
• Study Start: April 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 7, 2012

Record last verified: 2012-05

Locations

US (1)