NCT05137665 Target ALS Biomarker Study; Longitudinal Biofluids, Clinical Measures, and At Home Measures
| NCT ID | NCT05137665 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Target ALS Foundation, Inc. |
| Condition | Amyotrophic Lateral Sclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2021-06-01 |
| Primary Completion | 2031-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2021-06-01 with a primary completion date of 2031-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of the study is to generate a biorepository of longitudinal biofluids-blood (plasma and serum), cerebral spinal fluid (CSF) and urine linked to genetics and longitudinal clinical information that are made available to the research community. To accomplish these goals, we will enroll 800 Amyotrophic Lateral Sclerosis (ALS) patients and 200 healthy controls from sites globally, over a 5 year time frame. Additionally, speech and motor function and spirometry measures will be collected bi-weekly in a subset of participants. ALS participants will be asked to come to the clinic for 5 study visits approximately every 4 months. Healthy participants will be coming for 2 study visits with a 12-month interval between visits. These samples and clinical information will be stored in a de-identified manner and made available for investigators to use in future research studies.
Eligibility Criteria
ALS Participants: 1. Age 18 or older. 2. A diagnosis of ALS in accordance with Gold Coast criteria. 3. Full Vital Capacity (FVC) of ≥30% or at the discretion of the Principal Investigator for the participant's predicted value for gender, height, and age at the time of screening. 4. Ability to provide informed consent and understand the purpose and risks of the study. 5. Ability to comply with study procedures and assessments, in the opinion of the Principal Investigator. Healthy Control Participants: 1. Age 18 or older. 2. No history of neurological disease, in the opinion of the Principal Investigator. 3. No known ALS- associated genetic mutations at the time of consent. 4. Ability to provide informed consent and understand the purpose and risks of the study. 5. Ability to comply with study procedures and assessments, in the opinion of the Principal Investigator.
Contact & Investigator
Laura Dugom, MPH
STUDY DIRECTOR
Target ALS Foundation, Inc.
Frequently Asked Questions
Who can join the NCT05137665 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Amyotrophic Lateral Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05137665 currently recruiting?
Yes, NCT05137665 is actively recruiting participants. Contact the research team at laura.dugom@targetals.org for enrollment information.
Where is the NCT05137665 trial being conducted?
This trial is being conducted at Phoenix, United States, San Diego, United States, Georgetown, United States, Jacksonville, United States and 8 additional locations.
Who is sponsoring the NCT05137665 clinical trial?
NCT05137665 is sponsored by Target ALS Foundation, Inc.. The principal investigator is Laura Dugom, MPH at Target ALS Foundation, Inc.. The trial plans to enroll 1,000 participants.
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