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
This trial accepts healthy volunteersQualifiers
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 population
An initial cohort of approximately 2000 to 3000 participants will be recruited for this study. This includes at least 1600 symptomatic ALS participants (Cohort 1) and at least 450 control participants (Cohort 2). Though the exact percentages of in-clinic and remote participants are unknown at this time, it is anticipated that approximately 600 of the symptomatic ALS participants and 450 of the control participants will be recruited from the site clinic or local ALS community and will be coming to the sites for study visits. These numbers may differ substantially from the final enrollment numbers based on preference of participants enrolling in the study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
2,000 Participants
are grouped into 3 trial groupsGroup A: Symptomatic ALS on-site participants
Group B: Symptomatic ALS off-site (remote) participants
Group C: Control participants
Trial outcomes
Primary outcomes
1
ALS Functional Rating Scale-Revised (ALSFRS-R)
Questionnaire administered by a clinician that includes a series of questions about participants' ability to function in certain daily activities. Each type of function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Patients with higher scores have more physical function.
Time frame
Baseline, 4, 8, 12, 16, 20 and 24 months for ALS participants only.2
ALS Functional Rating Scale-Revised Self entry (ALSFRS-RSE)
Questionnaires completed by participants that includes questions about participants ability to function in certain daily activities. Each type of function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Patients with higher scores have more physical function.
Time frame
Baseline, 2, 4 ,6, 8, 10, 12, 14,16, 18,20, 22 and 24 months for ALS participants onlySecondary outcomes
1
ALS Impairment Multidomain scale (AIMS)
Questionnaires completed by participants that assess severity of the ALS disease
Time frame
1, 3, 5,7,9,11,13,15,17,19,21 and 23 months from baseline for ALS participants only2
Social Determinants of Health
Questionnaires completed by participants that includes questions about non-medical factors that affect health outcomes
Time frame
Months 3 and 4 for all cohorts3
Environmental History
Questionnaires completed by participants that includes questions about environmental exposures such as chemicals, smoking, alcohol etc.
Time frame
Month 1 for all cohorts4
Cognitive assessment (ECAS)
ECAS is a multi-domain assessment administered by study staff, to evaluate different aspects of cognitive function
Time frame
Baseline, 12 and 24 months for all cohortsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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