Answer ALS: Individualized Initiative for ALS Discovery (AnswerALS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02574390 |
Recruitment Status :
Completed
First Posted : October 12, 2015
Last Update Posted : January 13, 2020
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Condition or disease |
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Amyotrophic Lateral Sclerosis Primary Lateral Sclerosis Flail Arm ALS Progressive Muscular Atrophy Monomelic Amyotrophy Motor Neuron Disease Asymptomatic ALS Gene Carriers Healthy Controls |
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 1049 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 1 Year |
Official Title: | Answer ALS -Creation of a Large Bio-repository of iPS Cells, Cell Lines, and Bio-fluid Samples, Combined With Clinical Information to Rapidly Advance Therapeutics That Could Treat ALS |
Actual Study Start Date : | December 2015 |
Actual Primary Completion Date : | December 31, 2019 |
Actual Study Completion Date : | January 1, 2020 |

- ALS Functional Rating Scale-Revised (ALSFRS-R) [ Time Frame: once every 3 months for one year ]12 questions about patient's ability to function in certain activities of daily living. Each question is out of 4 with 4 being normal and 0 being completely impaired.
- ALS Cognitive Behavioral Scale (ALS-CBS) [ Time Frame: once every 3 months for one year ]short measure of cognition and behavior in patients with ALS. The cognitive portion consists of 8 tasks with a perfect score being 20. The behavioral portion measures changes in personality and behavior since the onset of ALS symptoms as well as mood, pseudobulbar affect and fatigue and is completed by a family member or caregiver. A normal score is 45.
- Slow Vital Capacity (SVC) [ Time Frame: once every 3 months for one year ]measurement of the maximum amount of air that can be exhaled following a deep breath.
- Strength Testing with Hand Held Dynamometer (HHD) [ Time Frame: once every 3 months for one year ]muscle strength testing performed on upper and lower limbs, ankles, wrists and fingers using a small hand held device. These measurements are followed over time and compared to measure decline.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Participants with familial or sporadic ALS diagnosed as possible, laboratory-supported probable, probable or definite according to the World Federation of Neurology (WFN) El Escorial criteria, Primary Lateral Sclerosis Flail Arm ALS, Progressive Muscular Atrophy, Monomelic Amyotrophy, Motor Neuron Disease, Asymptomatic ALS Gene Carriers
- Participants who are ages 18-100, inclusive.
Exclusion Criteria:
- Participants with Spinal-Bulbar Muscular Atrophy
- Known diagnosis of HIV/AIDS, Hepatitis B, or Hepatitis C.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02574390
United States, California | |
Cedars-Sinai Medical Center | |
Los Angeles, California, United States, 90048 | |
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30322 | |
United States, Illinois | |
Northwestern University Feinberg School of Medicine | |
Chicago, Illinois, United States, 60611 | |
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21205 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
United States, Missouri | |
Washington University School of Medicine | |
Saint Louis, Missouri, United States, 63110 | |
United States, Ohio | |
Ohio State University Wexner Medical Center | |
Columbus, Ohio, United States, 43221 | |
United States, Texas | |
Texas Neurology | |
Dallas, Texas, United States, 75214 |
Principal Investigator: | Nicholas J Maragakis, MD | Johns Hopkins University | |
Principal Investigator: | James D Berry, MD | Massachusetts Generel Hospital |
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT02574390 |
Other Study ID Numbers: |
IRB00082277 |
First Posted: | October 12, 2015 Key Record Dates |
Last Update Posted: | January 13, 2020 |
Last Verified: | January 2020 |
ALS stem cell biomarker disease progression |
Motor Neuron Disease Amyotrophic Lateral Sclerosis Muscular Atrophy Muscular Atrophy, Spinal Sclerosis Pathologic Processes Atrophy Pathological Conditions, Anatomical Neurodegenerative Diseases |
Nervous System Diseases Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases Neuromuscular Manifestations Neurologic Manifestations |