Imaging Biomarkers in ALS
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology, Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 21 - 75 |
| Updated: | 5/9/2018 |
| Start Date: | September 2015 |
| End Date: | September 2025 |
A Longitudinal Study of Imaging Biomarkers in Amyotrophic Lateral Sclerosis (ALS)
The purpose of the study is to determine if we are able to find one or more biomarkers of
Amyotrophic Lateral Sclerosis (ALS) and Primary Lateral Sclerosis (PLS) using magnetic
resonance imaging (MRI) scans at different levels, 3 tesla (3T) and 7 tesla (7T). A biomarker
is a measurable characteristic that can be used as an indicator of a particular disease
state. Identifying biomarkers of a disease can lead to a better understanding of the disease
as well as improved treatments. This study will enroll patients with ALS, PLS, and healthy
controls.
Amyotrophic Lateral Sclerosis (ALS) and Primary Lateral Sclerosis (PLS) using magnetic
resonance imaging (MRI) scans at different levels, 3 tesla (3T) and 7 tesla (7T). A biomarker
is a measurable characteristic that can be used as an indicator of a particular disease
state. Identifying biomarkers of a disease can lead to a better understanding of the disease
as well as improved treatments. This study will enroll patients with ALS, PLS, and healthy
controls.
Inclusion Criteria:
- 21 to 75 years of age inclusive.
- Willing and able to give signed informed consent that has been approved by the
Institutional Review Board (IRB).
ALS patients:
- A clinical diagnosis of possible, laboratory-supported probable, probable, or definite
ALS, according to a modified El Escorial criteria.
Exclusion Criteria:
- Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease,
etc).
- Clinically significant history of unstable medical illness (unstable angina, advanced
cancer, etc) over the last 30 days.
- Inability to undergo MRI scanning, including but not limited to unable to remain still
in an MRI scanner for more than 30 minutes, claustrophobia, presence of paramagnetic
substances or pacemakers in body, weight over 300 lbs, or in the opinion of the
investigator, if there is a strong likelihood that the subject would not be able to
lie flat comfortably for 75-90 minutes.
- The subject requires assistance to ambulate OR climb stairs, unless in the opinion of
the investigator, and based upon the subject's rate of disease progression, the
subject is likely to be able to participate in the MRI screening 12 months after
enrollment.
We found this trial at
1
site
Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: David Walk, MD
Phone: 612-301-1535
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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