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A Longitudinal Study of Amyotrophic Lateral Sclerosis (ALS) Biomarkers

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ClinicalTrials.gov Identifier: NCT01495390
Recruitment Status : Completed
First Posted : December 20, 2011
Last Update Posted : May 30, 2017
ALS Association
ALS Finding a Cure
Information provided by (Responsible Party):
James D. Berry MD, Massachusetts General Hospital

Tracking Information
First Submitted Date December 16, 2011
First Posted Date December 20, 2011
Last Update Posted Date May 30, 2017
Study Start Date November 2011
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 14, 2015)
  • ALS Functional Rating Scale [ Time Frame: Approximately every 4 months ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title A Longitudinal Study of Amyotrophic Lateral Sclerosis (ALS) Biomarkers
Official Title A Multicenter Study for the Discovery and Validation of ALS Biomarkers
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
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.
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
  • Amyotrophic Lateral Sclerosis
  • Nervous System Diseases
  • Sclerosis
  • Motor Neuron Disease
  • Spinal Cord Diseases
  • Central Nervous System Diseases
  • Neurodegenerative Diseases
  • Neuromuscular Diseases
  • ALS
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 24, 2017)
Original Estimated Enrollment
 (submitted: December 19, 2011)
Actual Study Completion Date December 31, 2016
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
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.
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT01495390
Other Study ID Numbers BIO-ALS-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party James D. Berry MD, Massachusetts General Hospital
Original Responsible Party Merit E. Cudkowicz, MD, Massachusetts General Hospital, Principal Investigator
Current Study Sponsor Massachusetts General Hospital
Original Study Sponsor Same as current
  • ALS Association
  • ALS Finding a Cure
Principal Investigator: James D. Berry, MD, MPH Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date May 2017