ASSESS ALL ALS Study
a study on Amyotropic Lateral Sclerosis (ALS) Acute Lymphoblastic Leukemia
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Healthy Volunteers
- healthy people welcome
- Location
- at San Francisco, California and other locations
- Dates
- study startedcompletion around
Description
Summary
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 begin 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.
Official Title
ASSESS ALL ALS - Longitudinal Biomarker Study for Symptomatic ALS and Control Participants
Keywords
Amyotrophic Lateral Sclerosis, ALS, biomarker, observational, Motor Neuron Disease, Sclerosis
Eligibility
You can join if…
Open to people ages 18 years and up
for ALS participants:
- Age 18 years or older
- Capable of providing informed consent
- Willing to follow study procedures
- Diagnosis of ALS by a physician
- Access to a smartphone, computer or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient)
Inclusion Criteria for control participants:
- Age 18 years or older
- Capable of providing informed consent
- Willing to follow study procedures
- No diagnosis of ALS , Progressive Muscular Atrophy (PMA) or Primary Lateral Sclerosis (PLS)
- No history of familial ALS/Frontotemporal Dementia (FTD) in a close family member** unless the participant has previously tested negative for the known causative ALS genes. Participants with a family history of singleton ALS are permitted to enroll.
- ** Defined by the presence of a known ALS causative gene such as C9orf72 in a family member or a family history suggestive of an inherited ALS/FTD syndrome defined by two family members with a history of ALS and/or FTD.
- Access to a smartphone, computer or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient)
You CAN'T join if...
for all participants:
- 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.
Exclusion Criteria for participants undergoing optional Lumbar Puncture
- 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.
- Use of anticoagulant medication or antiplatelet medications (aside from aspirin 81 mg) that cannot be safely withheld prior to lumbar puncture.
- Blood dyscrasia, abnormal bleeding diathesis, or the use of dialysis for renal failure.
- Current pregnancy based on participant self-report
- Clinical judgement of the site investigator that the participant would be unable to undergo multiple lumbar punctures.
Locations
- UCSF
accepting new patients
San Francisco California 94143 United States - University of California, Irvine
accepting new patients
Irvine California 92868 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
- ID
- NCT06578195
- Study Type
- Observational
- Participants
- Expecting 2000 study participants
- Last Updated
Frequently Asked Questions
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study, which might include an external sponsor. Submitting your contact information does not obligate you to participate in research.
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If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT06578195.