Study Purpose:
The purpose of this study is to learn more about amyotrophic lateral sclerosis (ALS) and other related neurodegenerative diseases, including frontotemporal dementia (FTD), primary lateral sclerosis (PLS), hereditary spastic paraplegia (HSP), progressive muscular atrophy (PMA) and multisystem proteinopathy (MSP). More precisely, the investigator wants to identify the links that exist between the disease phenotype (phenotype refers to observable signs and symptoms) and the disease genotype (genotype refers to your genetic information). The investigator also wants to identify biomarkers of ALS and related diseases.
Study Status:
Recruiting
Disease:
Amyotrophic Lateral Sclerosis (ALS) , Familial ALS , Sporadic ALS , Primary Lateral Sclerosis (PLS) , Hereditary Spastic Paraplegia (HSP) , Healthy Volunteer , Healthy Volunteer with a Family History of ALS
Study Type:
Observational
Type of Intervention:
N/A
Intervention Name:
N/A
Placebo:
N/A
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Michael Benatar, MD, PhD University of Miami
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
University of Miami
Michael Benatar, MD, PhD / email hidden; JavaScript is required / 844-837-1031
Miami, Florida, 33136 United States
Study Sponsor:
University of Miami
Estimated Enrollment:
300
Estimated Study Start Date:
01 / 08 / 2021
Estimated Study Completion Date:
06 / 30 / 2024
Posting Last Modified Date:
05 / 12 / 2021
Date Study Added to neals.org:
05 / 12 / 2021
Accepts healthy volunteers:
Yes
Minimum Age:
7
Can participants use Riluzole?
Yes
Study Population
Primary participants - patients that have or are suspected to have ALS or a related disease.
Secondary participants - family members of primary participants enrolled in the study
Criteria
Inclusion Criteria for affected individuals (primary participants) include:
- Clinical diagnosis or suspicion of ALS or a related disorder, including, but not limited to, ALS-FTD, PLS, HSP, FTD, Multisystem Proteinopathy (MSP) and PMA.
- Subject is able and willing to comply with study procedures
Exclusion Criteria for affected individuals (primary participants) include:
- Subjects with a condition or who are in a situation which, in the PI's opinion, could confound the study finding or may interfere significantly with the individual's participation and compliance with the study protocol -- including but not limited to neurological, psychological and/or medical conditions
Inclusion criteria for biological family members (secondary participants) include:
- Family member of an enrolled affected primary participant
Exclusion Criteria for biological family members (secondary participants) include:
- Subjects with a condition or who are in a situation which, in the PI's opinion, could confound the study finding or may interfere significantly with the individual's participation and compliance with the study protocol -- including but not limited to neurological, psychological and/or medical conditions
University of Miami
Jessica Hernandez / 305-243-2345 / email hidden; JavaScript is required
Miami, Florida
33136
United States
University of Kansas Medical Center
Collin Gerringer / 913-748-5701 / email hidden; JavaScript is required
Kansas City, Kansas
66160
United States
University of Pennsylvania
Luis Rosario / 215-898-3081 / email hidden; JavaScript is required
Philadelphia, Pennsylvania
19104
United States
University of Cape Town
Jeannine Heckmann, MD / +27 (021) 404-3198 / email hidden; JavaScript is required
Cape Town
South Africa