PREVENT 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 begin 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. PREVENT protocol is specific for asymptomatic participants who are genetically at risk for ALS. The participants will be followed for up to 36 months (3 years), and will include 4 in-person on-site visits once a year and 6 off-site(remote) visits once in 4 months. The study includes 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 in 4 months. Participants may also provide optional Cerebrospinal Fluid (CSF) samples.The participants may also opt into a sub-study if they are interested in genetic testing for ALS causative genes. The sub-study will involve a minimum of 3 visits over a course of 2-3 months. This will include a screening/pre-test genetic counseling visit, a return of genetic results and a post-test counseling visit.

Key Dates

Start date

Jul 25, 2024

Status verified

Jan 2025

Primary completion

Jan 31, 2029

Completion

Jul 25, 2029

Study Design

Enrollment

600 participants (estimated)

Primary Outcome Measure

ALS Symptoms Questionnaire [ Time Frame: Baseline, 4, 8, 12,16,20, 24, 28, 32 and 36 months form baseline ]

Central Contacts

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

Locations (31)

Find similar trials in Birmingham, AL

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