A Longitudinal Study of Amyotrophic Lateral Sclerosis (ALS) Biomarkers

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

A Multicenter Study for the Discovery and Validation of ALS Biomarkers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01495390
• Other study ID #: BIO-ALS-02
• Status: Completed
• Phase: N/A
• First received: December 16, 2011
• Last updated: May 24, 2017
• Start date: November 2011
• Est. completion date: December 31, 2016

Study information

• Verified date: May 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ALS
• Amyotrophic Lateral Sclerosis
• Central Nervous System Diseases
• Motor Neuron Disease
• Nervous System Diseases
• Neurodegenerative Diseases
• Neuromuscular Diseases
• Sclerosis
• Spinal Cord Diseases

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Massachusetts Medical Center	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	ALS Association, ALS Finding a Cure

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ALS Functional Rating Scale	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.	Approximately every 4 months
Primary	Vital Capacity (VC)	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.	Approximately every 4 months
Primary	Hand Held Dynamometry (HHD)	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.	Approximately every 4 months
Primary	Ashworth Spasticity Scale	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.	Approximately every 4 months
Primary	Fronto-Temporal Dementia (FTD) Assessment	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.	Approximately every 4 months
Primary	ALS Cognitive Behavioral Screen (ALS CBS)	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.	Approximately every 4 months

External Links

•   Northeast ALS Consortium Website