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MRI Biomarkers in ALS

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ClinicalTrials.gov Identifier: NCT02405182
Recruitment Status : Recruiting
First Posted : April 1, 2015
Last Update Posted : May 14, 2018
Sponsor:
Collaborators:
University of Calgary
Western University, Canada
McGill University
University of Toronto
Information provided by (Responsible Party):
Sanjay Kalra, University of Alberta

Brief Summary:

Amyotrophic lateral sclerosis (ALS) is a disabling and rapidly progressive neurodegenerative disorder. There is no treatment that significantly slows progression. Increasing age is an important risk factor for developing ALS; thus, the societal impact of this devastating disease will become more profound as the population ages. A significant hurdle to finding effective treatment has been an inability to accurately measure brain degeneration in humans. Advanced magnetic resonance imaging (MRI) techniques hold promise in this respect, and may assist in aiding diagnosis and the efficient testing of new drugs.

Different MRI features of brain degeneration will be measured in a large sample of patients with ALS. The study will operate within the Canadian ALS Neuroimaging Consortium (CALSNIC). CALSNIC is a clinical research platform comprised of ALS clinics with standardized clinical and neuroimaging protocols.


Condition or disease Intervention/treatment
Amyotrophic Lateral Sclerosis ALS Motor Neuron Diseases Other: Magnetic Resonance Imaging

Detailed Description:

This study will use advanced Magnetic Resonance Imaging (MRI) techniques to measure brain changes in ALS and related neurological conditions. Results from cognitive and neurological tests will be compared to the MRI. It is believed that these techniques will reveal changes in the brain that will help us understand normal brain function and the symptoms of neurological diseases as seen in ALS, as well to provide an objective measurement of degeneration (which is called a biomarker). This could improve not only the process by which new drugs for the treatment of neurological diseases are evaluated, but also how health care professionals address the needs of patients with these diseases.

Furthermore, a biomarker may give insight into the biological factors related to the diverse and variable clinical features amongst different patients.

Subjects will be recruited from ALS clinics that are a part of the Canadian ALS Neuroimaging Consortium (CALSNIC). Patients will have a diagnosis of ALS, PLS, PMA, or FTD. Healthy controls will be age and gender matched to patients. Subjects will visit their respective sites to undergo a clinical evaluation and an MRI. Follow up visits will occur at approximately 3-6 month intervals. Most subjects will have 2 follow up visits; more visits may occur for subjects who are physically able to continue in the protocol.


Study Type : Observational
Estimated Enrollment : 195 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Magnetic Resonance Imaging Biomarkers in Amyotrophic Lateral Sclerosis
Actual Study Start Date : September 2014
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : January 2020


Group/Cohort Intervention/treatment
Patients
ALS patients (as well as patients with other motor neuron diseases such PLS and PMA) will be recruited from ALS clinics under the direction of ALS neurologists who are participating in this study. ALS patients should meet research criteria for possible, probable, probable laboratory-supported, or definite ALS. Patients with a history of CNS disease (e.g. stroke, head injury) or significant psychiatric disease will be ineligible. Patients must be able to undergo a brain MRI for approximately an hour.
Other: Magnetic Resonance Imaging
Other Name: MRI

Controls
Healthy controls who are age and gender matched to patients will be recruited. Controls with a history of CNS disease (e.g. stroke, head injury) or significant psychiatric disease will be ineligible. Controls must be able to undergo a brain MRI for approximately an hour.
Other: Magnetic Resonance Imaging
Other Name: MRI




Primary Outcome Measures :
  1. Change in neuronal and white matter integrity measures. [ Time Frame: 24 months ]
    The primary analysis will evaluate changes in the brain using various advanced MRI techniques at baseline and specified follow up periods. Patients and controls scans will be compared.


Secondary Outcome Measures :
  1. Correlation of neuronal and white matter integrity measures with clinical indices. [ Time Frame: 30 months ]
    Secondary analyses will involve MRI comparison to clinical measures both at the time of the baseline scan and over time.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited predominantly from ALS clinics at: the University of Alberta Hospital in Edmonton; the Foothills Medical Centre in Calgary; the Sunnybrook Health Sciences Centre in Toronto; the London Health Sciences Centre in London; and the Montreal Neurological Hospital in Montreal.
Criteria

Inclusion Criteria:

  • Patients will be adults with a diagnosis of motor neuron disease (MND), including those with ALS, PLS, and PMA, and as well frontotemporal dementia (FTD) without motor neuron signs.
  • Healthy controls over the age of 40 will also be recruited and will be age- and gender-matched to patients.

Exclusion Criteria:

  • Subjects with other psychiatric/CNS illnesses such as Major Depressive Disorder, Schizophrenia, and Bipolar disorder, and those with significant head injury.
  • Subjects ineligible for MRI investigation due to a pacemaker or other metallic foreign body, or significant claustrophobia that could affect the ability to have an MRI scan.

These exclusion criteria will also apply to controls.


Information from the National Library of Medicine

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): NCT02405182


Contacts
Contact: Dennell M Mah, BA 780-248-1805 dennell.mah@ualberta.ca

Locations
Canada, Alberta
University of Calgary / Heritage Medical Research Clinic Active, not recruiting
Calgary, Alberta, Canada, T2N 4Z6
University of Alberta Active, not recruiting
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
University of British Columbia / GF Strong Rehab Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 2G9
Contact: Marife Fabros, RN    604-737-6319    marife.fabros@vch.ca   
Canada, Ontario
Western University / London Health Sciences Centre Completed
London, Ontario, Canada, N6A 5A5
University of Toronto / Sunnybrook Health Sciences Centre Active, not recruiting
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
McGill University / Montreal Neurological Institute and Hospital Completed
Montreal, Quebec, Canada, H3A 2B4
Sponsors and Collaborators
University of Alberta
University of Calgary
Western University, Canada
McGill University
University of Toronto
Investigators
Principal Investigator: Sanjay Kalra, MD, FRCPC University of Alberta

Responsible Party: Sanjay Kalra, Associate Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT02405182     History of Changes
Other Study ID Numbers: RES0013831
First Posted: April 1, 2015    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

Keywords provided by Sanjay Kalra, University of Alberta:
Magnetic Resonance Imaging
MRI
Biomarker

Additional relevant MeSH terms:
Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases