Target ALS Biomarker Study

06 Jun Target ALS Biomarker Study

The purpose of this study is to generate a biorepository of longitudinal blood (plasma and serum), cerebral spinal fluid (CSF), and urine linked to genetics and clinical information that are made available to the ALS research community for future research. These samples will be stored in a central biorepository and help us collect data to improve care delivery for and develop new treatments for ALS.

Both ALS participants and healthy control participants will be enrolled.

ALS participants will complete a total of 5 clinic visits across a 16-month period. Healthy control participants will complete a total of 2 clinic visits across a 12-month period. Optional, at-home speech assessments will be collected bi-weekly for participants in both groups if interested. These samples and clinical information will be de-identified and made available for investigators to use in future research studies.

Participants will also be compensated for completion of study visits, and travel-related expenses (ie. parking, mileage, incidentals) will be covered by the study.

Learn more about the Target ALS Global Natural History Study here:

Donate Biofluid Samples

Participant Eligibility

Inclusion Criteria
Patients and healthy control individuals are eligible to consent and be included in the study only if they meet their respective cohort criteria below.

ALS Participants:

1. Age 18 or older
2. A diagnosis of ALS in accordance with Gold Coast criteria
3. Full Vital Capacity (FVC) of ≥30% at the time of screening
4. A score of 2 or more on item one (speech) of the ALS-FRS scale
5. Ability to provide informed consent and understand the purpose and risks of the study
6. Ability to comply with study procedures and assessments

Healthy Control Participants:

• Age 18 or older
• No history of neurological disease
• No known ALS-associated genetic mutations
• Ability to provide informed consent and understand the purpose and risks of the study
• Ability to comply with study procedures and assessments

Exclusion Criteria
Patients and healthy control individuals are excluded from the study if they meet the criteria below.

ALS and Healthy Control Participants:

1. Any known or suspected abnormal CSF pressure or intracranial/intraspinal tumors
2. Use of antiplatelet or anticoagulant medication (i.e., warfarin, dalteparin, enoxaparin, rivaroxaban, fondaparinux, dabigatran, etc.) that cannot safely be interrupted for lumbar puncture according to local standard of care and/or institutional guidelines
3. Blood dyscrasia, abnormal bleeding diathesis, or the use of dialysis for renal failure

Contact

Kaycie Opiyo
(206) 616-3132