Longitudinal Study of Innate Lymphoid Cells in Peripheral Blood in ALS

NCT03090932 | Terminated

• 1 other identifier: HUM00107546
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Amyotrophic lateral sclerosis (ALS) is a devastating neurodegenerative disorder characterized by progressive muscle weakness and eventual death. Studies demonstrate that the immune system plays a key role in ALS progression; however, the role of the immune system is unclear, as various aspects can play both a beneficial and detrimental role in the disease course. Attempts to universally suppress the immune system in ALS patients have at best had negligible effects on progression or at worst accelerated the disease. Thus, there is a critical need to identify immune cell populations to serve as biomarkers and therapeutic targets.

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• Total number of classical NK (natural killer) cells; total number of CD3+ CD4+ CD8+ cells

  Total number of classical NK cells; total number of CD3+ CD4+ CD8+ cells

  Every 28 days (+/- 5 days) for 12 total visits over 36 months

Secondary Outcomes (1)

• Cytokine expression

  Every 28 days (+/- 5 days) for 12 total visits over 36 months

Interventions

Blood draw OTHER

Research subjects will have two tubes of blood drawn, approximately 20mL.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ALS patients (200) and matched controls (75)

You may qualify if:

• Age 18 years or older.
• Clinically definite, probable, probable laboratory supported, or possible ALS by El Escorial criteria
• Fluency in English at the 6th grade level or higher.
• Able to communicate sufficiently well by speaking
• Able to communicate over the phone.
• Capable of providing informed consent.
• Lives geographically accessible to the University of Michigan

You may not qualify if:

• Unable to provide informed consent.
• Clinically significant dementia, as judged by the site investigator.
• Other neurological or psychiatric disorders which are expected to impair cognitive function.
• Other serious and uncontrolled medical disorders.
• History of autoimmune disease.
• Use of prednisone, IVIG, or immunosuppression within the last 12 months.
• Not geographically accessible to the University of Michigan

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Innate lymphoid cells from whole blood

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Blood Specimen Collection

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ben Murdock, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Investigator

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 27, 2017
• Study Start: January 18, 2016
• Primary Completion: November 13, 2020
• Study Completion: November 13, 2020
• Last Updated: January 12, 2022

Record last verified: 2021-12

Locations

US (1)