Protocol Details
ASSESS ALL ALS Study
This study is currently recruiting participants.
Summary
Number |
002271-N |
Sponsoring Institute |
National Institute of Neurological Disorders and Stroke (NINDS) |
Recruitment Detail |
Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 99 Years |
Referral Letter Required |
No |
Population Exclusion(s) |
Adults who are or may become unable to consent;
Children |
Keywords |
Amyotrophic Lateral Sclerosis |
Recruitment Keyword(s) |
None |
Condition(s) |
Amyotrophic Lateral Sclerosis;
Neurodegenerative Diseases;
Neuromuscular Diseases;
TDP-43 Proteinopathies;
Motor Neuron Disease |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
National Institute of Neurological Disorders and Stroke |
Background:
Amyotrophic lateral sclerosis (ALS) is an inherited disease that damages motor nerve cells in the brain and spinal cord. To test new treatments for ALS, researchers need to recruit many participants across wide geographical areas. They need to find ways to measure results that work just as well remotely as they do in a clinic.
Objective:
To collect samples and other data for future research on ALS.
Eligibility:
Adults aged 18 years and older who have ALS. Healthy volunteers are also needed.
Design:
Participants with ALS will complete 7 study visits in 2 years. Some will have clinic visits; others will have only remote visits.
Participants will be screened. They will answer questions about how ALS affects their lives. They will have tests of memory and language skills. They will install an app so they can make speech recordings; they will read phrases and make sounds. Clinic participants will have blood drawn and tests of their breathing and muscle strength. Remote participants will have blood drawn by a local nurse.
Participants will repeat their visits 6 more times, every 4 months.
Each month at home, they will take an online survey about their health, daily life, and well-being. They will make speech recordings.
Clinic participants may opt to have a lumbar puncture. A needle will be inserted into the space around the spinal cord to withdraw a fluid sample.
Healthy participants will have 3 clinic visits in 2 years. They will have blood drawn and tests of their breathing and muscle strength. They will have tests of memory and language skills. They will complete online surveys each month. They will install an app so they can make speech recordings.
Eligibility
INCLUSION CRITERIA:
Inclusion Criteria 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 mutation (such as C9orf72) in a relative such that the potential participant is at risk for carrying that mutation 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)
EXCLUSION CRITERIA:
Exclusion Criteria for all participants:
-Significant cognitive impairment that would interfere with the participant's ability to provide informed consent, in the opinion of the person obtaining consent.
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.
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT06578195