PRE-Symptomatic Studies in Amyotrophic Lateral Sclerosis

NCT01508962 | Active Not Recruiting DMC

• 1 other identifier: PRESS-ALS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of PRESS-ALS is to study the earliest manifestations of disease in people with early ALS in whom some areas of the body are not yet affected.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Disease onset; Disease progression

Outcome Measures

Primary Outcomes (1)

• Phenoconversion

  Every three months over the course of one year

Study Arms (2)

Healthy individuals (controls)

Individuals affected with ALS (sporadic or familial)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People affected with ALS (either familial or sporadic) and healthy controls

You may qualify if:

• ALS group:
• Subject is a male or female, aged at least 18 years.
• Subject is affected with ALS (familial or sporadic).
• Subject has at least one limb in which there is no symptomatic upper and lower motor neuron dysfunction.
• Subject is willing and able to comply with all study procedures.
• Subject agrees to provide signed and dated informed consent form.
• Control group:
• Subject is a male or female, aged at least 18 years.
• Subject is not affected with ALS or an ALS-related disorder.
• Subject does not have a family history (i.e., at least 2 biological relatives) of ALS or an ALS-related disorder.
• Subject is willing and able to comply with all study procedures.
• Subject agrees to provide signed and dated informed consent form.
• Any condition or situation which, in the PI's opinion, could confound the biomarker data 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).

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Disease Progression

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: January 9, 2012
• First Posted: January 12, 2012
• Study Start: November 1, 2013
• Primary Completion (Estimated): December 1, 2037
• Study Completion (Estimated): December 1, 2037
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)