PET Imaging in ALS Patients

Amyotrophic Lateral Sclerosis (ALS) Clinical Trial

Official title:

Metabotropic Glutamate Receptor 5 (mGluR5) Imaging in Amyotrophic Lateral Sclerosis (ALS) Patients and Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02236897
• Other study ID #: NA_00073452
• Status: Completed
• Phase: N/A
• First received: September 8, 2014
• Last updated: March 6, 2017
• Start date: August 2013
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Amyotrophic Lateral Sclerosis (ALS)
• Motor Neuron Disease
• Sclerosis

Intervention

Other:
• PET Scanning

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	ALS Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glutamate Receptor Distribution	The two primary outcome variables (VT and BPND) are quantitative estimates of mGluR5 distribution in the defined central nervous system regions. We will employ plasma reference graphical analysis (PRGA) which yielded the most accurate estimates of BPND and VT in a test-retest scheme. We will perform various analyses to determine if BPND or VT measurements in the volumes of interest differ between the ALS and control subject groups.	1 year