Markers of Inflammation in Patients with Motor Neuron Disease (ALS and ALS Variants)
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Scottsdale/Phoenix, Arizona: 16-006111
Sponsor Protocol Number: 16-006111
About this study
The purpose of this study is to identify patients with a diagnosis of Amyotrophic Lateral Disease (ALS) or ALS variants who have laboratory markers of inflammation or autoimmunity. Presently, there is no effective therapy for treatment of ALS or ALS variants. Recent evidence suggests that some patients with ALS who have laboratory markers of inflammation may respond to therapies that modulate immune system function. The aim of this study is to determine what percentage of patients with ALS and ALS variants have positive laboratory markers of inflammation or autoimmunity. This study will also determine what percentage of patients with ALS or ALS variants chose to receive immunotherapy. Furthermore, the study will determine what percentage of patients with ALS or ALS variants respond to immunotherapy and which specific forms of immunotherapy are effective. Finally, the study will determine the duration that positive markers of inflammation remain elevated during the year of observation and if immunotherapy affects the results of laboratory markers of inflammation.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- Patients must be adults of ages 18- 100 years old.
- Patients must have clinical features that are consistent with a diagnosis of ALS or one of the ALS variants including progressive muscular atrophy (PMA), primary lateral sclerosis (PLS) or progressive bulbar palsy (PBP).
- Patients must have cognitive function sufficient to understand the nature of the study and provide consent to participate.
- Patients must have a lab test result for high sensitivity C reactive protein within the last 4 months.
- Patients who do not meet criteria for ALS or ALS variants.
- Patients with impaired cognitive function who are not able to understand the nature of the study or provide consent.
- Patients who have taken any form of immunotherapy within the preceding 6 months or regular antiinflammatory medication including aspirin or non-steroidal antiinflammatory drugs within the preceding 2 months.
- Patients with concurrent cancer, infection, or active rheumatologic disorders such as vasculitis, systemic lupus erythematosus, or inflammatory joint or bowel disorders.
- Patients who have not had a lab test result for high sensitivity C reactive protein within the last 4 months.
- Women who are pregnant or may become pregnant during the study.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
Mark Ross, M.D.
Closed for enrollment
Publications are currently not available
Study Results Summary
Not yet available
Supplemental Study Information
Not yet available