A Longitudinal Study of Amyotrophic Lateral Sclerosis (ALS) Biomarkers
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.
Amyotrophic Lateral Sclerosis
Nervous System Diseases
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A Multicenter Study for the Discovery and Validation of ALS Biomarkers|
- ALS Functional Rating Scale [ Time Frame: Approximately every 4 months ] [ Designated as safety issue: No ]The ALSFRS-R is a quickly administered (5 min) ordinal rating scale used to determine a subject's assessment of their capability and independence in 12 functional activities. There are 12 questions, graded by the subject 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing.
- Vital Capacity (VC) [ Time Frame: Approximately every 4 months ] [ Designated as safety issue: No ]The vital capacity (VC) (percent of predicted normal) was determined using the slow VC method. Vital Capacity is the maximum amount of air a person can expel from the lungs after a maximum inhalation. A subject's VC depends on their age, sex and height. The value is recorded as a percent of predicted normal.
- Hand Held Dynamometry (HHD) [ Time Frame: Approximately every 4 months ] [ Designated as safety issue: No ]Hand Held Dynamometry (HHD) will be used as a quantitative measure of muscle strength for this study. Six proximal muscle groups will be examined bilaterally in both upper and lower extremities (shoulder flexion, elbow flexion, elbow extension, hip flexion, knee flexion, and knee extension), all of which have been validated against maximum voluntary isometric contraction (MVIC) testing.
- Ashworth Spasticity Scale [ Time Frame: Approximately every 4 months ] [ Designated as safety issue: No ]This is a standard measure for spasticity, has been used in a previous ALS clinical trials, and is applied in the current trial to evaluate the progression of spasticity due to upper motor neuron dysfunction in ALS.
- Fronto-Temporal Dementia (FTD) Assessment [ Time Frame: Approximately every 4 months ] [ Designated as safety issue: No ]The FTD Screening Assessment is a quickly administered scale used to evaluate memory, executive functions, and language. It is aimed at determining the presence of subtle dysfunction of these domains of cognition and behavior that may portend the onset of FTD or FTD-like symptoms.
- ALS Cognitive Behavioral Screen (ALS CBS) [ Time Frame: Approximately every 4 months ] [ Designated as safety issue: No ]
The ALS Cognitive Behavioral Screen (ALS-CBS™) is a short measure of cognition and behavior in patients with Amyotrophic Lateral Sclerosis (ALS). The cognitive section includes commonly used elements of standard testing batteries, consisting of 8 tasks, with a possible total score of 20. It can be administered by a physician or other clinical care staff and takes approximately 5 minutes to complete.
The behavioral section (ALS Caregiver Behavioral Questionnaire) is composed of questions sensitive to organic brain changes. It consists of a set of questions that compare changes in personality and behavior since the onset of ALS, as well as yes/no questions about mood, pseudobulbar affect, and fatigue. It is completed by a caregiver, family member or other informant during the same time that the patient completes the cognitive portion. The questionnaire typically takes about 2 minutes to complete.
Biospecimen Retention: Samples With DNA
Biological samples will be collected from participants with ALS over time. These biological samples include blood (plasma, serum, and RNA) and cerebrospinal fluid (CSF). DNA will be collected at one time point.
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495390
|Contact: Sylvia Baedorf Kassis, MPHfirstname.lastname@example.org|
|United States, Arizona|
|Barrow Neurological Institute||Recruiting|
|Phoenix, Arizona, United States, 85013|
|Contact: Gale Kittle, RN, MPH 602-406-4792 Gale.Kittle@DignityHealth.org|
|Principal Investigator: Shafeeq Ladha, MD|
|United States, Florida|
|Mayo Clinic Jacksonville||Recruiting|
|Jacksonville, Florida, United States, 32224|
|Contact: Karen Overstreet 904-953-6523 email@example.com|
|Principal Investigator: Kevin Boylan, MD|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Contact: Latoya Shaw 404-727-1673 Latoya.firstname.lastname@example.org|
|Principal Investigator: Jonathan Glass, MD|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Christina Dheel 617-643-6252 email@example.com|
|Principal Investigator: James Berry, MD, MPH|
|University of Massachusetts Medical Center||Recruiting|
|Worcester, Massachusetts, United States, 01655|
|Contact: Diane McKenna-Yasek 508-856-4697 firstname.lastname@example.org|
|Principal Investigator: Robert Brown, MD, DPhil|
|United States, Pennsylvania|
|University of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Danielle Rowlands, RN 412-648-9053 doerdx@UPMC.EDU|
|Principal Investigator: David Lacomis, MD|
|Principal Investigator:||James D. Berry, MD, MPH||Massachusetts General Hospital|