Evaluation of microglial activation using the PET imaging ligand [18F]PBR06 in patients with amyotrophic lateral sclerosis compared to healthy volunteers
The purpose of this study is to evaluate whether an investigational imaging agent called [18F]PBR06 is able to detect changes in the brain that occur in patients with ALS.
Disease:Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALS, Healthy Volunteer
Study Type:Observational Study
Study Category:Drug Trial , Biomarkers/Imaging
Study Status:Not enrolling
Study Chair(s)/Principal Investigator(s):
Ken Marek, MD (Institute for Neurodegenerative Disorders)
Michelle Lavallee Dagostine, MD (Institute for Neurodegenerative Disorders)
Clinicaltrials.gov ID (11 digit #):
Coordinating Center Contact InformationInstitute for Neurodegenerative Disorders
New Haven, Connecticut 06510 United States
Full Study Summary:
This research will evaluate whether an investigational imaging agent called [18F]PBR06 is able to detect changes in the brain that occur in patients with ALS.
The main purpose of this study is to find out whether this imaging test is able to detect inflammation in the brain of patients with ALS. In this study we will be using the experimental radioactive drug [18F]PBR06 in individuals with ALS and healthy volunteers.
Study Sponsor:Denali Therapeutics
72 days, including a 45 day screening period
Estimated Enrollment:20 (12 ALS and 8 Healthy Volunteers)
Estimated Study Start Date:06/27/2016
Estimated Study Completion Date:06/30/2017
Posting Last Modified Date:01/12/2018
Date Study Added to alsconsortium.org:10/19/2016
Time since Symptom Onset:N/A
Time since Diagnosis:N/A
Can participants use Riluzole?Yes
- Sporadic or familial ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by the modified El Escorial criteria;
- Medications for ALS subjects should be stable for 30 days prior to the Screening Visit and remain unchanged during the subject’s participation in the study
- Participant is able and willing to undergo testing (MRI, PET, radioactive tracer injection).
- Current or prior history of alcohol or drug abuse.
- Evidence of dementia
- Current tobacco use including cigarettes, cigars, and chewing tobacco, or nicotine-containing products such as gum, patch, or “electronic cigarettes”.
- Contraindications to PET, PET-CT, or MR (e.g. electronic medical devices, inability to lie still for long periods) that makes it unsafe for the individual to participate.
- Severe claustrophobia.
- Currently pregnant or breast-feeding.
- Subject has received an investigational therapeutic within 30 days prior to screening.
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