Study Purpose:
This is a pilot study to evaluate a potential imaging biomarker for aiding diagnosis and monitoring progression of ALS, based on a well established basic science pathway, published human autopsy data, preliminary data in ALS mutant mice, and our recently published data using brain PET scans to image the metabotropic glutamate receptor type 5 (mGluR5) in healthy human volunteers.Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis (ALS)
Study Type:
Interventional
Type of Intervention:
N/A
Intervention Name:
PET Scanning
Placebo:
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Lyle Ostrow, MD, PhD, Johns Hopkins University
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Johns Hopkins University
Baltimore, Maryland, 21287 United States
Full Study Summary:
This is a pilot study to evaluate a potential imaging biomarker for aiding diagnosis and monitoring progression of ALS, based on a well established basic science pathway, published human autopsy data, preliminary data in ALS mutant mice, and our recently published data using brain PET scans to image the metabotropic glutamate receptor type 5 (mGluR5) in healthy human volunteers.
Study Sponsor:
Johns Hopkins University
Estimated Enrollment:
36
Estimated Study Start Date:
07 / 31 / 2013
Estimated Study Completion Date:
03 / 01 / 2017
Posting Last Modified Date:
03 / 07 / 2017
Date Study Added to neals.org:
09 / 11 / 2014
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years. To learn more, visit: https://clinicalt...CT02236897&rank=1
Minimum Age:
18 Years
Maximum Age:
80 Years
Inclusion Criteria:- Male or female ALS patients, ranging in age from 18-80.
- Must meet El Escorial Criteria for Probable or Definite ALS.
- Disease duration >1 year, but <3 years.
- Weakness in at least two extremities.
- Forced vital capacity less than 80% and greater than 50%.
Exclusion Criteria:
- Documented orthopnea or otherwise unable to lie flat in a PET scanner for 90 minutes.
- Presence of pacemakers, aneurysm clips, shrapnel, or other implanted metallic devices that would preclude an MRI scan.
- Absence of sufficient collateral arterial circulation for radial arterial line placement in both wrists.
- Significant abnormalities of hepatic or renal function, or illicit substance use.
- Positive drug screen. (Subjects currently taking prescribed narcotic medication who have a positive drug screen for this medication will not be excluded. Medication history will be obtained during screening).
- Weighs > 350 lbs.
Johns Hopkins University
Baltimore, Maryland
21287
United States