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PRE-Symptomatic Studies in Amyotrophic Lateral Sclerosis

PRE-Symptomatic Studies in Amyotrophic Lateral Sclerosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01508962
Acronym
PRESS-ALS
Enrollment
100
Registered
2012-01-12
Start date
2013-11-01
Completion date
2037-12-01
Last updated
2026-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Disease onset, Disease progression

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.

Interventions

None listed

Sponsors

University of Miami
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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. Exclusion Criterion • 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).

Design outcomes

Primary

MeasureTime frame
PhenoconversionEvery three months over the course of one year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026