NCT07007390

Brief Summary

The goal of this observational study is to identify molecular features in multiple clinical samples and/or the patient environment that are associated with ALS. Participants will collect biological samples and answer questionnaires regarding their health at each appointment with their ALS practitioner.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
49mo left

Started Jun 2025

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Jun 2025May 2030

First Submitted

Initial submission to the registry

March 28, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2025

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2030

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2030

Last Updated

June 5, 2025

Status Verified

June 1, 2025

Enrollment Period

4.7 years

First QC Date

March 28, 2025

Last Update Submit

June 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Molecular features of biological samples that are predictive of ALS progression

    We will collect samples and health data from each participant from the time of diagnosis to their death or study termination, whichever comes sooner. Specific time frame: We will collect outcome measures through study completion, an average of 3 years.

Study Arms (2)

ALS Cohort

Patients of Dr. Espíndola at UFSC that are diagnosed with ALS and meet the inclusion/exclusion criteria.

Control Cohort

Those that meet the inclusion/exclusion criteria, do not have ALS, and generally are healthy.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ALS cohort: Patients of Dr. Espíndola at UFSC Control cohort: Participants from the general population

You may qualify if:

  • Patient of Dr. Espíndola at UFSC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Raquel Clinical Research Coordinator, BS

CONTACT

Momo Chief Science Officer, Head of Clinical Research, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2025

First Posted

June 5, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

February 1, 2030

Study Completion (Estimated)

May 1, 2030

Last Updated

June 5, 2025

Record last verified: 2025-06