Clinical Research in ALS Study (CRiALS)

University of Miami

Status: Enrolling

Conditions: Amyotrophic Lateral Sclerosis

Study type: Observational

Funder types: Other

Identifiers

NCT00136500

20101021

Details and patient eligibility

About

CRiALS is an umbrella protocol through which people are recruited to participate in a range of research studies being conducted by the ALS Research Collaboration (ARC).

Full description

Research goals include elucidation of the complex relationship between ALS and related neurodegenerative disorders, development of both wet and dry biomarkers of disease, and delineation of the full course of the natural history of disease from the early pre-symptomatic stages through established and even late-stage disease. These goals are accomplished through the recruitment and evaluation of patients with ALS and related diseases, family members (including people at genetic risk for ALS, but who are not yet affected), and healthy controls.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. At least 18 years of age.

2. Member of at least one of the following categories:

   1. Individuals affected with ALS or a related neurodegenerative disease (sporadic or familial)
   2. Unaffected individuals from fALS pedigrees, including pre-symptomatic individuals at genetic risk for ALS or individuals from pedigrees of ALS related diseases.
   3. Healthy controls

3. Able and willing to comply with relevant procedures.

Exclusion criteria

1. Subject has a condition or is in a situation which, in the PI's opinion, could confound the study finding or may interfere significantly with the individual's participation and compliance with the study protocol -- including but not limited to neurological, psychological and/or medical conditions (e.g., multiple sclerosis, neuropathy, myelopathy).

Trial design

10,000 participants in 4 patient groups

Individuals affected with ALS

Description:

This population be sporadic or familial ALS.

Unaffected individuals from families in which the genetic cause of ALS is known

Description:

This population includes pre-symptomatic individuals at genetic risk for ALS or a related neurodegenerative disorder (i.e., FTD).

Individuals affected with an ALS-related neurodegenerative disease

Description:

This would include FTD, MSP, IBMPFD, etc.

Healthy controls