Target ALS Biomarker Study; Longitudinal Biofluids, Clinical Measures, and At Home Measures

Conditions

• Amyotrophic Lateral Sclerosis
• Degenerative Disorder
• Motor Neuron Disease
• Movement Disorders

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Study Details

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.

Key Dates

Start date

Jun 1, 2021

Status verified

Nov 2025

Primary completion

Dec 31, 2031

Completion

Dec 31, 2031

Study Design

Enrollment

1,000 participants (estimated)

Arms

• Arm: Amyotrophic Lateral Sclerosis ALS
  This is a global, multi-center study of ALS participants and healthy controls that will have up to 20 sites globally. Target enrollment will be approximately 1000 participants with 800 ALS participants and 200 healthy control cases. Research participants with suspected, possible, probable, probable- laboratory supported, and definite Amyotrophic Lateral Sclerosis (ALS), according to the revised El Escorial Criteria (EEC) or with a diagnosis based on the Gold Coast Criteria will be seen at the Screening/Baseline Visit(s) (Visit 1) and follow-up will occur at approximate 4-month internals for up to 5 visits per participant.
• Arm: Healthy
  Healthy control participants will have a neurological exam to confirm non-neurologic disease status and participants will have one follow up visit approximately 12 months after their baseline visit. Upon consenting for participation, all study participants will undergo the activities and biofluid collections at each visit.

Primary Outcome Measure

Biofluid Biorepository [ Time Frame: + 3.5 Years ]

Central Contacts

• Laura Dugom, MPH
  919-440-2073
  [email protected]
• Robert Bowser, PhD
  602-406-8989
  [email protected]

Locations (10)

Find similar trials in Phoenix, AZ

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