Access for All in ALS (ALL ALS) East Clinical Coordinating Center

The objective of this proposal, called Access for aLL in ALS (ALL-ALS), is to establish 1) a Clinical and Data Coordinating Center, 2) an Amyotrophic lateral sclerosis (ALS) Clinical Research Consortium of 30 US ALS centers serving diverse populations, and 3) a robust, prospective, longitudinal observational and biomarker study of 2000+ people living with ALS and 500 healthy participants who harbor gene mutations known to cause ALS and are at high risk of developing the disease (“asymptomatic ALS gene carriers”).

The ALL-ALS Coordinating Center activities will be carried out by the Neurological Clinical Research Institute (NCRI) of Mass General Hospital, MA as the Coordinating Center, Barrow Neurological Institute (BNI), AZ as the Site Monitoring and Outcomes Training Center and will be working with the Northeast ALS Consortium (NEALS) for consortium building.

To ensure success of this proposal, MGH NCRI and BNI will bring their two decades of collaborative experience functioning as coordination center and leading scores of high-quality, multi-site ALS observational studies, biobanking projects and clinical trials, in partnership with industry, academic investigators, and not-for-profit research groups.

The NEALS Consortium is the largest and geographically widespread consortium of sites in the ALS field; the multiple PIs of this project include the two current NEALS co-chairs, 2 executive committee members, and one founding co-chair.

We will involve NEALS primarily to engage both established sites and also newer ALS clinical sites to include a mix of academic centers, community hospitals, and private practices across the US who are committed to conducting high quality and operationally complex ALS trials. A strong focus on underserved areas will be considered for site selection and consortium building.

In addition, we will build upon existing NEALS educational, training and knowledge sharing activities for all sites, site staff and other stakeholders in the community.

A new ALL-ALS Scholars Program will offer training in community engagement science and clinical trials to early-stage investigators to expand the number of culturally competent clinical ALS researchers.

A comprehensive, evidence-based community engaged research (CER) team will guide a scalable and culturally informed plan to ensure recruitment and ALS community engagement consortium-wide.

Our CER strategies will focus on ensuring geographic, ethnocultural, and socioeconomic diversity, equity, inclusion and offering educational training opportunities to the ALS patient and clinic community. The ALL-ALS consortium will conduct the largest observational/biobanking ALS study ever undertaken.

This study will include prospective collection of clinical, biofluid, digital and imaging biomarker data, collected longitudinally from symptomatic and asymptomatic ALS-gene carrier populations.

The ALL-ALS study will contribute large and harmonized longitudinal ALS datasets collected from the study to central NIH ALS data repositories for further study by the ALS research community as a part of open science, which would be valuable to drive clinical and therapeutic innovations in ALS.

An adjunct study within this larger effort will recruit and longitudinally evaluate a large cohort of asymptomatic ALS gene carriers. The ALL-ALS Consortium is designed to run studies independently, or in conjunction with other funded consortia.