Clinical trial NCT01495390: A Longitudinal Study of Amyotrophic Lateral Sclerosis (ALS) Biomarkers
Official title: A Multicenter Study for the Discovery and Validation of ALS Biomarkers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyotrophic Lateral Sclerosis
Nervous System Diseases
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
ALS
Keywords: Biomarkers
Biological Markers
Surrogate Markers
Clinical Markers
Plasma
Cerebrospinal Fluid
DNA
Serum
RNA
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: ALS Association
name: ALS Finding a Cure
First posted: 2011-12-20
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers will be invited to participate in this study by their neurologists either in clinic or at a regular scheduled appointment visit

Brief summary: The purpose of this study is to collect biofluid samples for the banking and usage in ALS research. Through comparison of these samples, the researchers hope to learn more about the underlying cause of ALS, as well as find unique biological markers, which could be used to develop new therapies.

Detailed description: The purpose of the research study is to collect blood samples and cerebrospinal fluid (CSF) from people with amyotrophic lateral sclerosis (ALS). These samples will be collected approximately every 4 months.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Diagnosis of suspected, possible, probable or definite ALS according to El Escorial Criteria
* Vital capacity (VC) at least 50 percent predicted
* Able to undergo multiple lumbar punctures

Exclusion Criteria:

* Abnormal CSF pressure or intracranial/intraspinal tumors
* Use of anticoagulant medication that cannot be safely withheld
* Bleeding disorders

  * This is a partial listing.

Primary outcomes:
measure: ALS Functional Rating Scale
timeFrame: Approximately every 4 months
measure: Vital Capacity (VC)
timeFrame: Approximately every 4 months
measure: Hand Held Dynamometry (HHD)
timeFrame: Approximately every 4 months
measure: Ashworth Spasticity Scale
timeFrame: Approximately every 4 months
measure: Fronto-Temporal Dementia (FTD) Assessment
timeFrame: Approximately every 4 months
measure: ALS Cognitive Behavioral Screen (ALS CBS)
timeFrame: Approximately every 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical Center
state: Massachusetts
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: Massachusetts General Hospital
name: James D. Berry, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: