Evaluation of microglial activation using the PET imaging ligand [18F]PBR06 in patients with amyotrophic lateral sclerosis compared to healthy volunteers

Study Purpose:

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:

Active, currently recruiting

Phase:

Phase I

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 #):

Neals Affiliated?

No

Coordinating Center Contact Information

Institute for Neurodegenerative Disorders
Meghan Pajonas, RN / .(JavaScript must be enabled to view this email address) / 203-508-1506
.(JavaScript must be enabled to view this email address) 60 Temple Street
Suite 8B
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

Participant Duration:

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:

11/29/2016

Date Study Added to alsconsortium.org:

10/19/2016
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    80

    Time since Symptom Onset:

    N/A

    Time since Diagnosis:

    N/A

    Can participants use Riluzole?

    Yes


    Inclusion Criteria:

    • 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).

    Exclusion Criteria:

    • 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.

  • Site Contact Information

    Institute for Neurodegenerative Disorders
    Meghan Pajonas, RN / .(JavaScript must be enabled to view this email address) / 203-508-1506
    60 Temple Street, Suite 8A
    New Haven, Connecticut 06510
    United States