[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05116943":3,"trial-entities:NCT05116943":80,"trial-summary:NCT05116943":85},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":27,"secondary_outcomes":38,"sex":39,"minimum_age":40,"maximum_age":21,"healthy_volunteers":41,"eligibility_criteria":42,"std_ages":54,"locations":57,"central_contacts":73,"overall_officials":74,"references":78,"see_also_links":79},"NCT05116943","13-004314","Biospecimen Biorepository for the Study of ALS, ALS-FTD and Similar Neurodegenerative Disorders","RECRUITING","2030-01","2025-12","2025-12-16","2013-08-19","Mayo Clinic","OTHER",false,"The purpose of this study is to collect CSF and blood samples that can be used in future research studies to identify potential biomarkers in blood and cerebrospinal fluid (CSF) collected in Amyotrophic Lateral Sclerosis (ALS) patients.","Biomarkers are non-genetic elements in your blood and CSF that may help diagnose and monitor ALS more easily. There are no readily available sources of longitudinal CSF, plasma or serum samples from people with ALS, ALS-FTD or similar neurodegenerative disorders or their family members for use in the identification of potential ALS biomarkers. Future research will examine potential biomarkers in blood and CSF collected over time to see if they change over time and can be used to diagnose and monitor people with ALS.",[18],"Amyotrophic Lateral Sclerosis",[],"OBSERVATIONAL",null,[],{"count":24,"type":25},100,"ESTIMATED",[],[28,32,35],{"measure":29,"description":30,"timeFrame":31},"Blood serum collection","Total number of blood serum samples collected","10 years",{"measure":33,"description":34,"timeFrame":31},"Blood plasma collection","Total number of blood plasma samples collected",{"measure":36,"description":37,"timeFrame":31},"Cerebrospinal fluid collection","Total number of cerebrospinal fluid samples collected",[],"ALL","18 Years",true,{"inclusion":43,"exclusion":49,"raw_text":53},[44,45,46,47,48],"Clinical diagnosis of possible, laboratory-supported probable, probable or definite ALS according to modified eL Escorial criteria, suspected ALS according to original el Escorial criteria, or diagnosis of a similar neurodegenerative disorder.","Willing to provide consent, or assent, if physically unable to consent owing to disease-related muscle weakness.","No personal history of ALS, ALS-FTD or other motor neuron disease.","Subjects with family history of ALS, ALS-FTD the affected family member needs to be a first, second, or third degree blood relative.","Willing to provide consent.",[50,51,52,51,52],"History of medical disorder that leaves in question whether neurological signs and symptoms potentially related to a neurodegenerative disease may be caused by another unrelated disorder.","Limited mental capacity rendering the subject unable to comply with lumbar puncture or standard phlebotomy procedures.","For lumbar puncture, an increased risk of bleeding complications or allergy to local anesthetic administered or skin antiseptic used for lumbar puncture.","Inclusion Criteria - Patient with ALS, ALS-FTD or Similar Neurodegenerative Disease:\n\n* Clinical diagnosis of possible, laboratory-supported probable, probable or definite ALS according to modified eL Escorial criteria, suspected ALS according to original el Escorial criteria, or diagnosis of a similar neurodegenerative disorder.\n* Willing to provide consent, or assent, if physically unable to consent owing to disease-related muscle weakness.\n\nInclusion Criteria - Spouse\u002FDomestic Partner of Patients with ALS\u002FALS-FTD and Similar Neurodegenerative Disorder or Subject with Family History of ALS, ALS-FTD or Similar Neurodegenerative Disease:\n\n* No personal history of ALS, ALS-FTD or other motor neuron disease.\n* Subjects with family history of ALS, ALS-FTD the affected family member needs to be a first, second, or third degree blood relative.\n* Willing to provide consent.\n\nExclusion Criteria - Subject with ALS\u002FALS-FTD or Similar Neurodegenerative Disease:\n\n* History of medical disorder that leaves in question whether neurological signs and symptoms potentially related to a neurodegenerative disease may be caused by another unrelated disorder.\n* Limited mental capacity rendering the subject unable to comply with lumbar puncture or standard phlebotomy procedures.\n* For lumbar puncture, an increased risk of bleeding complications or allergy to local anesthetic administered or skin antiseptic used for lumbar puncture.\n\nExclusion Criteria - Spouse\u002FDomestic Partner of Patients with ALS\u002FALS-FTD and Similar Neurodegenerative Disorder or Subject with Family History of ALS, ALS-FTD or Similar Neurodegenerative Disease:\n\n* Limited mental capacity rendering the subject unable to comply with lumbar puncture or standard phlebotomy procedures.\n* For lumbar puncture, an increased risk of bleeding complications or allergy to local anesthetic administered or skin antiseptic used for lumbar puncture.",[55,56],"ADULT","OLDER_ADULT",[58],{"facility":59,"status":7,"city":60,"state":61,"zip":62,"country":63,"contacts":64,"geoPoint":70},"Mayo Clinic in Florida","Jacksonville","Florida","32224","United States",[65],{"name":66,"role":67,"phone":68,"email":69},"Alex Burch, BA","CONTACT","(904)9532000","burch.alex@mayo.edu",{"lat":71,"lon":72},30.33218,-81.65565,[],[75],{"name":76,"affiliation":12,"role":77},"Bjorn Oskarsson, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":81,"biomarkers":84},[18,82,83],"Degenerative Disease of Nervous System, Unspecified","Frontotemporal Dementia",[],{"nct_id":4,"found":41,"summary":86,"prompt_version":96},{"design":87,"status":88,"heading":89,"summary":90,"follow_up":91,"word_count":92,"commitments":93,"compensation":94,"drugs_mentioned":95},"This is an observational study that plans to enroll 100 participants. It is not testing a specific intervention or drug.","completed","Biospecimen Biorepository for ALS and Similar Neurodegenerative Disorders","This study is collecting blood and cerebrospinal fluid (CSF) samples from people with Amyotrophic Lateral Sclerosis (ALS), ALS-Frontotemporal Dementia (ALS-FTD), and similar neurodegenerative disorders. The goal is to build a collection of these samples that can be used in future research to find biomarkers. Biomarkers are non-genetic elements in your body that could help doctors diagnose and monitor ALS more easily. You may be able to join if you are 18 years or older and have a clinical diagnosis of ALS or a similar neurodegenerative disorder. The study aims to collect samples for 10 years to see if potential biomarkers change over time. The current recruitment status is unclear.","Blood serum, blood plasma, and cerebrospinal fluid will be collected for 10 years.",109,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]