The University of Pittsburgh Medical Center; The Live Like Lou Center for ALS Research would like to inform you about an ongoing research study.  We are currently seeking volunteers diagnosed with Amyotrophic Lateral Sclerosis (ALS) for participation in a clinical study.

Study Purpose:

The purpose of the study is to develop a repository of blood and cerebrospinal fluid (CSF) samples from people with ALS.  We plan to use these samples to help scientists in identifying biomarkers associated with ALS (what changes are unique to ALS).  These markers could be used to understand the causes of the disease and thus may lead to new therapies for ALS.  Furthermore, these markers may also serve as indicators of disease progression that could potentially be used in future clinical trials.

Your participation will include blood draws, including DNA collection, and lumbar punctures for collection of spinal fluid every 6 months for a total of 4 visits.

Contact: If you would like more information or would like to participate, please contact 412-864-2873 or email us at doerdx@upmc.edu

Full Study Summary:

The Northeast ALS Consortium (NEALS) biorepository is an existing resource which has provided scientists with a wide range of samples associated with clinical information. Our goal is to continue to build this repository with this collection protocol to associate biofluid collection with specific measures of upper and lower motor neuron function. This project will compliment others to upgrade the NEALS biorepository infrastructure, including updating the computer systems, expanding the number of sample freezers and establishing a repository in the Western United States, and strengthening the standard operating procedures for the repository. The project also supports existing efforts to expand the biorepository by collecting new blood and spinal fluid samples from people with ALS. This is a multicenter, non-interventional, longitudinal study in patients with ALS. There will be four (4) subject visits in this study: Baseline, month 6, month 12, and month 18. At each visit, subjects will have biofluids collected, and be evaluated with assessment tools that focus on upper and lower motor neuron burden as well as cognitive function.

The primary objective of the study is to obtain information on patients studied at regular intervals over 18 months, in conjunction with biofluid collection over that same time period. The secondary objective of the study is to integrate data from this study to other ongoing projects via the NEALS biorepository, and future collections now being planned. The outcome measures of this study are as follows:

• Motor unit number estimation will be performed on bilateral upper extremity muscles using the multipoint incremental technique (MIMNUE)
• Vital capacity, measured using slow vital capacity (SVC)
• Lower motor neuron excitability will be assessed with threshold tracking nerve conduction studies (ttNCS) in the least affected intrinsic hand muscle
• Cognitive abnormalities will be assessed using the ALS Cognitive Behavior Screen (ALS-CBS™)
• Hand held dynamometry (HHD) will be performed on 9 muscle groups tested bilaterally
• Global function (ALSFRS-R)

At each visit, blood will be collected and banked for biomarker discovery; CSF will be collected at baseline, month 6, and at month 18.

Study Sponsor:

The ALS Association and Fulton Family Foundation

Participant Duration:

18 months