ASSESS ALL ALS Study

Conditions

• Amyotrophic Lateral Sclerosis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Study Details

The ALL ALS Clinical Research Consortium is establishing research to collect a wide range of samples, clinical information and measurements from Amyotrophic Lateral Sclerosis (ALS) symptomatic, ALS gene carriers and control cohorts. This consortium is being funded by the National Institutes of Health/National Institute of Neurological Disorders and Stroke (NIH/NINDS) and managed by two clinical coordinating centers (CCC) at Barrow Neurological Institute and Massachusetts General Hospital. The clinical sites are distributed across the country, and led by a group of collaborative principal investigators. Once data and samples are collected and harmonized, it will be made available to research community for future research into ALS and related neurological diseases. ASSESS protocol is specific for symptomatic ALS and control participants. This protocol includes both on-site and off-site(remote) participants. The participants will be followed for 24 months (2 years), and will include collection of medical history, clinical outcomes, and blood samples once in 4 months. Additionally, the participants will complete patient reported outcomes and speech recordings once a month. Participants who are coming into clinic may also provide optional Cerebrospinal Fluid (CSF) samples.

Key Dates

Start date

Jul 25, 2024

Status verified

Sep 2025

Primary completion

Jan 31, 2029

Completion

Jul 25, 2029

Study Design

Enrollment

2,000 participants (estimated)

Arms

• Arm: Symptomatic ALS on-site participants
  Symptomatic ALS Participants who are completing on-site visits at one of the 35 participating ALL ALS sites.
• Arm: Symptomatic ALS off-site (remote) participants
  Symptomatic ALS Participants who are completing visits study visits remotely through video-conferencing. Home Phlebotomy is being used to collect blood from these participants.
• Arm: Control participants
  Control participants who do not have a diagnosis of ALS , Progressive Muscular Atrophy (PMA) or Primary Lateral Sclerosis (PLS). These participants complete on-site visits.

Primary Outcome Measure

ALS Functional Rating Scale-Revised (ALSFRS-R) [ Time Frame: Baseline, 4, 8, 12, 16, 20 and 24 months for ALS participants only. ]

Central Contacts

• ALL ALS Patient Navigator
  602-845-0248
  [email protected]

Locations (31)

Find similar trials in Birmingham, AL

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