ALSNCT05966038
ALS/MND Natural History Study Data Repository
An observational study of ALS and PLS, run by Massachusetts General Hospital at 18 sites in 3 countries.
Trial summary
This is a data repository for multi-site multi-protocol clinic-based Natural History Study of ALS and Other Motor Neuron Disorders (MND). All people living with ALS or other MNDs who attend clinics at the Study hospitals (sites) are offered to participate in the Study. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- ALS, PLS, MND (Motor Neurone DIsease)
- How many people
- 5,000 participants
- Where
- 18 sitesin 3 countries
- Study dates
- 1 Apr 2015to 31 Dec 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All people living with ALS/MND at participating multidisciplinary ALS/MND clinics
Who may be able to join
- A clinical diagnosis of El Escorial of suspected, possible, probable, or definite ALS or
- Other motor neuron disorders, including but not limited to Spinal-Bulbar Muscular Atrophy (SBMA, Kennedy's disease), Spinal Muscular Atrophy (SMA), Primary Lateral Sclerosis (PLS), Progressive Muscular Atrophy (PMA), and Progressive Bulbar Palsy (PBP)
Who cannot join
- Disease does not meet criteria for any motor neuron disorder
Trial locations and contacts
18 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 3 countries
United States14 sites, 14 recruiting
- Recruiting
Lahey Clinic
Burlington, Massachusetts, 01805
Sorieba Fofanah, 781-744-2958, Sorieba.Fofanah@lahey.org
Melo Catia, catia.s.melo@lahey.org
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Emma Schmidt, 312-503-4362, emma.schmidt@northwestern.edu
Senda Ajroud-Driss
- Recruiting
Henry Ford Health System
Detroit, Michigan, 48202
Anne Vallis, 313-916-1364, avallis1@hfhs.org
Ximena Arcila Londono
- Recruiting
University of Florida
Gainesville, Florida, 32610
Jennifer Steshyn, Jennifer.Steshyn@neurology.ufl.edu
James Wymer
- Recruiting
Trinity Health Michigan
Grand Rapids, Michigan, 49503
Nicolina Evola, 616-685-6195, nicolina.evola@trinity-health.org
Katherine Schwass, 616-685-5437, Katherine.Schwass@trinity-health.org
- Recruiting
Loma Linda University Health
Loma Linda, California, 92354
Jeffrey Rosenfeld, MD
- Recruiting
Kaiser Permanente
Los Angeles, California, 90027
Chris Greer, 323-783-9284, chris.x.lindgren@kp.org
Abel Wu, MD
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Valerie Ferment, 612-301-1535, ferm0016@umn.edu
David Walk
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Gemma Krautzel, 267-582-6061, Gemma.Krautzel@jefferson.edu
Hristelina Ilieva, MD
- Recruiting
Temple University Lewis Katz School of Medicine
Philadelphia, Pennsylvania, 19140
John Furey, 267-694-0573, john.furey0001@temple.edu
Terry Heiman-Patterson
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15360
Helen Ismail, 412-864-2873, ismailhh@upmc.edu
Tawfiq Al-lahham, MD
- Recruiting
Providence ALS Clinic
Portland, Oregon, 97213
Tyler Regan, 503-215-2333, tyler.regan@providence.org
Nicholas Olney
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 22908
Demetrius Carter, Demetrius.R.Carter@vcuhealth.org
Kelly Gwathmey
- Recruiting
Saint Louis University
St Louis, Missouri, 63104
Katie Forsman, katie.forsman@health.slu.edu
Ghazala Hayat
Israel2 sites, 2 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem, 9112001
Michal Zabari, michalza@hadassah.org.il
Marc Gotkine, MD
- Recruiting
Tel Aviv Medical Center
Tel Aviv, 64239
Beatrice Abramovich, beatricen@tlvmc.gov.il
Vivian Drori, MD
Italy2 sites, 2 recruiting
- Recruiting
Centro Clinico NEMO Milano
Milan, 20162
Monica Montuori, monica.montuori@centrocliniconemo.it
Federica Cerri
- Recruiting
Istituti Clinici Scientifici Maugeri SpA
Milan, 20138
Camilla Garrè, camilla.garre@icsmaugeri.it
Christian Lunetta, MD
About this study
This is a data repository for multi-site multi-protocol clinic-based Natural History Study of ALS and Other Motor Neuron Disorders (MND).
All people living with ALS or other MNDs who attend clinics at the Study hospitals (sites) are offered to participate in the Study.
Read more
The Sites collect so-called Baseline information including demographics, disease history and diagnosis, family history, etc. At each visit, the Sites also collect multiple disease-specific outcome measures and events. The information is captured in NeuroBANK, a patient-centric clinical research platform.
The Sites have an option to choose to collect data into 20+ additional forms capturing biomarkers and outcome measures. Captured data after its curation are anonymized (all personal identifiers and dates are being removed), and the anonymized dataset is shared with medical researchers via a non-exclusive revocable license.
Funding Source - Biogen, Inc.; Mitsubishi Tanabe Pharma America; FDA OOPD.
Read the detailed description
Most people with ALS or MND who are seen clinically by the PI or PI designees at participating sites will be recruited into this study. This well-established framework provides an opportunity to offer to a large proportion of people with ALS/MND a chance to participate in a clinical research project.
Upon obtaining consent, the following is done:
People with ALS/MND are assigned a Neurological Global Unique Identifier (NeuroGUID) and its study-specific derivative, NeuroSTAmP, which is used to link this Study's information to biological samples, images, and clinical data obtained from those individuals in this Study and other studies/trials, in which these patients participate(d).
The following information is captured in NeuroBANK platform:
Baseline information
- Longitudinal clinical and phenotypical data from routine clinical visits
- Longitudinal clinical and historical phenotypical data transcribed from electronic health records and notes
- Any other observational data that are of interest to the Investigator may be captured or linked to information in NeuroBANK.
Other Key Features
The site should track numbers of patients who declined participation. The site should have a mechanism in place to include an offer of participation to each patient in clinic (consenting does not require immediate data entry) Regular Data Quality checks may be performed at the site. Site personnel who intend to have access to NeuroBANK are trained and certified prior to given access.
Several registries, both cross-sectional and longitudinal, currently exist in ALS. NeuroBANK is distinct from other current registries in that it is a patient-centered platform that is designed to function as a data repository of patient data from clinical visits and multiple clinical research projects as well as linking these data to biorepository for tissue, imaging, and other biological information. This natural history study can act as a clinical research framework that may link clinical and clinical research data from current and past studies with biological specimens and image collections.
With obtained consents, biological specimens may be collected with bar-coded labels containing patient assigned study specific NeuroSTAmPs, printed from within NeuroBANK, and scanned into NeuroBANK's virtual distributed BioRepository module. Imaging studies are de-identified with NeuroSTAmPs and linked to clinical and phenotypical information. Anonymized clinical data obtained through this protocol are available to other researchers.
Study Population
Individuals who are seen during their clinical care visits are asked to allow their data to be uploaded and captured for clinical research. The NeuroBANK platform is located at and managed by the Center for Innovation and Bioinformatics (CIB), Neurological Clinical Research Institute (NCRI) of Massachusetts General Hospital (Boston, MA).
Consent Process
Every participant in the ALS clinic is approached to participate in this study. A signed informed consent form is obtained before any data are recorded for study purposes.
- Conditions
- ALS, PLS, MND (Motor Neurone DIsease), Kennedy Disease, PMA - Progressive Muscular Atrophy, PBP - Progressive Bulbar Palsy
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Bulbo-Spinal Atrophy, X-Linked, Muscular Atrophy, Spinal, Bulbar Palsy, Progressive
What is being measured
The primary outcome is the main question the study is designed to answer.
ALS Functional Rating Scale-Revised (ALSFRS-R)
The ALS Functional Rating Scale revised is a 12-item rating scale that measures the progression of disability in patients with ALS. The ALSFRS-r assesses patients' levels of self-sufficiency in areas of feeding, grooming, ambulation and communication. The higher the score, the earlier in the disease progression.
It consists of 12 questions with a maximum score of 48 points.
Measured: Every 3-4 months up to 5 years
Slow Vital Capacity (SVC)
Slow vital capacity test normalized to age, sex, and height
Measured: Every 3-4 months up to 5 years
Survival
Patient survival or survival equivalent (time to ventilator or feeding tube). Survival equivalent is assessed during routine clinical visits, while mortality event may be reported when becomes known to the treating clinician..
Measured: Every 3-4 months up to 5 years
Secondary outcomes (9)
Vital Signs
Vital Signs (Weight, BP, HR). Both systolic and diastolic pressure are measured.
Measured: Every 3-4 months up to 5 years
Neurological Examination
Neurological exam that tests for abnormality various areas, from general assessment to coordination and cerebellar function, to sensation and reflexes, to cranial nerves and plantar
Measured: Through study completion, annually up to 5 years
El Escorial Criteria
The El Escorial criteria are diagnostic criteria for ALS. They classify patients into categories of possible, probable, or definite ALS, based on signs of degeneration of upper and lower motor neurons in different body regions.
Measured: Through study completion, annually up to 5 years
Handheld Dynamometry
Handheld Dynamometry for quantitative strength testing of 18 muscles that is a reliable and reproducible measure of decline in ALS
Measured: Every 3-4 months up to 5 years
Grip Strength Testing
Grip Strength Testing
Measured: Every 3-4 months up to 5 years
Rasch Overall ALS Disability Scale (ROADS)
Rasch Overall ALS Disability Scale, the ROADS provides a normed total score on 28 items from 0-146 to capture overall disability level in a linearly-weighted manner, with lower scores indicating disease progression
Measured: Every 3-4 months up to 5 years
5 Times Sit to Stand
5 Times Sit to Stand Test
Measured: Every 3-4 months up to 5 years
10 Meter Walk Test
10 Meter Walk Test
Measured: Every 3-4 months up to 5 years
Physical Examination
Physical Examination that includes the following test areas for abnormality and clinical significance: respiratory, cardio, gastrointestinal, genitourinary. and musculoskeletal
Measured: Through study completion, annually up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Apr 2015
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALSStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Henry Ford Health System, Northwestern University, Temple University, St. Louis University, University of Florida, University of Minnesota, Virginia Commonwealth University, Fondazione Serena Onlus - Centro Clinico NeMO Milano, Providence Health & Services, University of Pittsburgh, Istituti Clinici Scientifici Maugeri SpA, Lahey Clinic, Hadassah Medical Organization, Tel Aviv Medical Center, Kaiser Permanente, Trinity Health Michigan, Thomas Jefferson University
- Responsible party
- Principal investigator, Alexander Sherman, Massachusetts General Hospital
- Investigators
- Alexander Sherman, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966038
- Sponsor's protocol ID
- 2013P001670
- Other IDs
- 5U01FD008125-02, 2022A011556, 2022A018800
- Status last verified
- May 2026
- First submitted
- 15 Jun 2023
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized IPD are being shared with data requestors upon submission of the research proposal online. Data Access Committee reviews submissions and upon approval and execution of the Data Sharing Agreement, the dataset is provided to the data requestor.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALS/MND Natural History Study Data Repository
- ClinicalTrials.gov ID
- NCT05966038
- Acronym / sponsor ID
- 2013P001670
- Conditions
- ALS, PLS, MND (Motor Neurone DIsease), Kennedy Disease, PMA - Progressive Muscular Atrophy, PBP - Progressive Bulbar Palsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Henry Ford Health System, Northwestern University, Temple University, St. Louis University, University of Florida, University of Minnesota, Virginia Commonwealth University, Fondazione Serena Onlus - Centro Clinico NeMO Milano, Providence Health & Services, University of Pittsburgh, Istituti Clinici Scientifici Maugeri SpA, Lahey Clinic, Hadassah Medical Organization, Tel Aviv Medical Center, Kaiser Permanente, Trinity Health Michigan, Thomas Jefferson University
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a data repository for multi-site multi-protocol clinic-based Natural History Study of ALS and Other Motor Neuron Disorders (MND).
All people living with ALS or other MNDs who attend clinics at the Study hospitals (sites) are offered to participate in the Study.
The Sites collect so-called Baseline information including demographics, disease history and diagnosis, family history, etc. At each visit, the Sites also collect multiple disease-specific outcome measures and events. The information is captured in NeuroBANK, a patient-centric clinical research platform.
The Sites have an option to choose to collect data into 20+ additional forms capturing biomarkers and outcome measures. Captured data after its curation are anonymized (all personal identifiers and dates are being removed), and the anonymized dataset is shared with medical researchers via a non-exclusive revocable license.
Funding Source - Biogen, Inc.; Mitsubishi Tanabe Pharma America; FDA OOPD.
Detailed description
Most people with ALS or MND who are seen clinically by the PI or PI designees at participating sites will be recruited into this study. This well-established framework provides an opportunity to offer to a large proportion of people with ALS/MND a chance to participate in a clinical research project.
Upon obtaining consent, the following is done:
People with ALS/MND are assigned a Neurological Global Unique Identifier (NeuroGUID) and its study-specific derivative, NeuroSTAmP, which is used to link this Study's information to biological samples, images, and clinical data obtained from those individuals in this Study and other studies/trials, in which these patients participate(d).
The following information is captured in NeuroBANK platform:
Baseline information
- Longitudinal clinical and phenotypical data from routine clinical visits
- Longitudinal clinical and historical phenotypical data transcribed from electronic health records and notes
- Any other observational data that are of interest to the Investigator may be captured or linked to information in NeuroBANK.
Other Key Features
The site should track numbers of patients who declined participation. The site should have a mechanism in place to include an offer of participation to each patient in clinic (consenting does not require immediate data entry) Regular Data Quality checks may be performed at the site. Site personnel who intend to have access to NeuroBANK are trained and certified prior to given access.
Several registries, both cross-sectional and longitudinal, currently exist in ALS. NeuroBANK is distinct from other current registries in that it is a patient-centered platform that is designed to function as a data repository of patient data from clinical visits and multiple clinical research projects as well as linking these data to biorepository for tissue, imaging, and other biological information. This natural history study can act as a clinical research framework that may link clinical and clinical research data from current and past studies with biological specimens and image collections.
With obtained consents, biological specimens may be collected with bar-coded labels containing patient assigned study specific NeuroSTAmPs, printed from within NeuroBANK, and scanned into NeuroBANK's virtual distributed BioRepository module. Imaging studies are de-identified with NeuroSTAmPs and linked to clinical and phenotypical information. Anonymized clinical data obtained through this protocol are available to other researchers.
Study Population
Individuals who are seen during their clinical care visits are asked to allow their data to be uploaded and captured for clinical research. The NeuroBANK platform is located at and managed by the Center for Innovation and Bioinformatics (CIB), Neurological Clinical Research Institute (NCRI) of Massachusetts General Hospital (Boston, MA).
Consent Process
Every participant in the ALS clinic is approached to participate in this study. A signed informed consent form is obtained before any data are recorded for study purposes.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All people living with ALS/MND at participating multidisciplinary ALS/MND clinics
Key inclusion criteria (2 listed)
- A clinical diagnosis of El Escorial of suspected, possible, probable, or definite ALS or
- Other motor neuron disorders, including but not limited to Spinal-Bulbar Muscular Atrophy (SBMA, Kennedy's disease), Spinal Muscular Atrophy (SMA), Primary Lateral Sclerosis (PLS), Progressive Muscular Atrophy (PMA), and Progressive Bulbar Palsy (PBP)
Key exclusion criteria (1 listed)
- Disease does not meet criteria for any motor neuron disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ALS Functional Rating Scale-Revised (ALSFRS-R)
Time frame: Every 3-4 months up to 5 years
The ALS Functional Rating Scale revised is a 12-item rating scale that measures the progression of disability in patients with ALS. The ALSFRS-r assesses patients' levels of self-sufficiency in areas of feeding, grooming, ambulation and communication. The higher the score, the earlier in the disease progression. It consists of 12 questions with a maximum score of 48 points.
Slow Vital Capacity (SVC)
Time frame: Every 3-4 months up to 5 years
Slow vital capacity test normalized to age, sex, and height
Survival
Time frame: Every 3-4 months up to 5 years
Patient survival or survival equivalent (time to ventilator or feeding tube). Survival equivalent is assessed during routine clinical visits, while mortality event may be reported when becomes known to the treating clinician..
9 secondary outcomes
Vital Signs
Time frame: Every 3-4 months up to 5 years
Neurological Examination
Time frame: Through study completion, annually up to 5 years
El Escorial Criteria
Time frame: Through study completion, annually up to 5 years
Handheld Dynamometry
Time frame: Every 3-4 months up to 5 years
Grip Strength Testing
Time frame: Every 3-4 months up to 5 years
Rasch Overall ALS Disability Scale (ROADS)
Time frame: Every 3-4 months up to 5 years
5 Times Sit to Stand
Time frame: Every 3-4 months up to 5 years
10 Meter Walk Test
Time frame: Every 3-4 months up to 5 years
Physical Examination
Time frame: Through study completion, annually up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- ALS/MND NATURAL HISTORY CONSORTIUMLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized IPD are being shared with data requestors upon submission of the research proposal online. Data Access Committee reviews submissions and upon approval and execution of the Data Sharing Agreement, the dataset is provided to the data requestor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander Sherman principal investigator
Massachusetts General Hospital
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ALS and PLS, run by Massachusetts General Hospital at 18 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Israel, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalia Tarasenko (1617240346, ntarasenko@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ALS Functional Rating Scale-Revised (ALSFRS-R) (time frame: Every 3-4 months up to 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.