Study Purpose:
The goals of this study are: (1) to better understand the relationship between the phenotype and genotype of amyotrophic lateral sclerosis (ALS) and related diseases, including primary lateral sclerosis (PLS), hereditary spastic paraplegia (HSP), progressive muscular atrophy (PMA), and frontotemporal dementia (FTD); and (2) to develop biomarkers that might be useful in aiding therapy development for this group of disorders.
Study Status:
Not 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, University of Miami
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
University of Miami
Sumaira Hussain / email hidden; JavaScript is required / 844-837-1031
Miami, Florida, 33136 United States
Full Study Summary:
This study will recruit patients with ALS, ALS-FTD, PLS, HSP, and PMA, with a focus on incident cases. Patients with both familial and sporadic forms of these diseases will be enrolled and followed longitudinally using a standardized set of evaluations. Biological samples (blood, urine, CSF) will be collected from all study participants, and will be used for biomarker discovery and validation. Family members of affected individuals may also be enrolled and asked to contribute DNA and biological samples to aid genetic and biomarker discovery.
Study Sponsor:
University of Miami
Estimated Enrollment:
700
Estimated Study Start Date:
04 / 01 / 2015
Estimated Study Completion Date:
06 / 30 / 2021
Posting Last Modified Date:
01 / 07 / 2021
Date Study Added to neals.org:
08 / 18 / 2015
Study Population
Patients with ALS or a related neurodegenerative disorder, including FTD, HSP, PLS, PMA and MSP. Select family members of affected participants.
Criteria
Inclusion Criteria:
- Member of at least one of the following categories:
- Individuals with a clinical diagnosis of ALS or a related disorder, including FTD, HSP, PLS, PMA and MSP (sporadic or familial).
- Family member of an enrolled affected individual.
- Able and willing to comply with relevant procedures.
Exclusion Criteria:
- Affected with end or late stage disease.
- A condition or 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. This includes (but is not limited to) neurological, psychological and/or medical conditions.
Stanford University
Michael Nguyen / 650-724-6147 / email hidden; JavaScript is required
Palo Alto, California
94304
United States
University of California San Diego (UCSD)
Gil Gutierrez / 858-246-2325 / email hidden; JavaScript is required
San Diego, California
92093
United States
California Pacific Medical Center (CPMC)
Simon Carty / 415-600-1368 / email hidden; JavaScript is required
San Francisco, California
94115
United States
University of Miami
Jessica Hernandez / 305-243-2345 / email hidden; JavaScript is required
Miami, Florida
33139
United States
University of Iowa
Jeri Sieren / 319-356-8744 / email hidden; JavaScript is required
Iowa City, Iowa
52242
United States
Kansas University Medical Center (KUMC)
Collin Gerringer / 913-748-5701 / email hidden; JavaScript is required
Kansas City, Kansas
66160
United States
Twin Cities ALS Research Consortium
Cindy Rohde / 612-873-2607 / email hidden; JavaScript is required
Minneapolis, Minnesota
55415
United States
Wake Forest University
Mozhdeh Marandi / 336-713-8577 / email hidden; JavaScript is required
Winston-Salem, North Carolina
27157
United States
Cleveland Clinic
Debbie Hastings / 216-445-3353 / email hidden; JavaScript is required
Cleveland, Ohio
44195
United States
University of Pennsylvania
Luis Rosario / 215-898-3081 / email hidden; JavaScript is required
Philadelphia, Pennsylvania
19104
United States
University of Texas Southwestern (UTSW)
Amy Conger / 214-648-0214 / email hidden; JavaScript is required
Dallas, Texas
75390
United States
University of Texas Health Science Center San Antonio (UTHSCSA)
Pamela Kittrell / 210-450-0524 / email hidden; JavaScript is required
San Antonio, Texas
78229
United States
University of Virginia (UVA)
Amruta Joshi / 434-982-0293 / email hidden; JavaScript is required
Charlottesville, Virginia
22908
United States
Eberhard Karls University of Tubingen
Tubingen
Germany
University of Cape Town
Cape Town
South Africa