ASSESS ALL ALS Study
ConditionAmyotrophic Lateral Sclerosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSt. Joseph's Hospital and Medical Center, Phoenix
About this trial
The ALL ALS Clinical Research Consortium is establishing research to collect a wide range of samples, clinical information and measurements from Amyotrophic Lateral Sclerosis (ALS) symptomatic, ALS gene carriers and control cohorts. This consortium is being funded by the National Institutes of Health/National Institute of Neurological Disorders and Stroke (NIH/NINDS) and managed by two clinical coordinating centers (CCC) at Barrow Neurological Institute and Massachusetts General Hospital. The clinical sites are distributed across the country, and led by a group of collaborative principal investigators. Once data and samples are collected and harmonized, it will be made available to research community for future research into ALS and related neurological diseases.
ASSESS protocol is specific for symptomatic ALS and control participants. This protocol includes both on-site and off-site(remote) participants. The participants will be followed for 24 months (2 years), and will include collection of medical history, clinical outcomes, and blood samples once in 4 months. Additionally, the participants will complete patient reported outcomes and speech recordings once a month. Participants who are coming into clinic may also provide optional Cerebrospinal Fluid (CSF) samples.
Eligibility criteria
Qualifiers
Age 18 years or older
Capable of providing informed consent
Willing to follow study procedures
Diagnosis of ALS by a physician
Disqualifiers
Significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression <= 90 days of screening, that would interfere with the study procedure, according to Investigator's judgement.
Clinically significant unstable medical condition (other than ALS) (e.g., cardiovascular instability, systemic infection, untreated thyroid dysfunction, malignant and potentially progressive cancer) that would render the participant unlikely to be able to complete 12 months of follow-up, according to Investigator's judgment.
Medically unable to undergo lumbar puncture (LP) as determined by the site investigator (i.e., bleeding disorder, a skin infection at or near the LP site, known or suspected intracranial or intraspinal tumor or other cause of increased intracranial pressure).
Allergy to Lidocaine or other local anesthetic agents.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
2,000 Participants
are grouped into 3 trial groupsSponsors and collaborators
St. Joseph's Hospital and Medical Center, Phoenix
Lead sponsor
Massachusetts General Hospital
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Foundation for the National Institutes of Health
Collaborator
Source ClinicalTrials.gov