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Glial Activation Measured by PBR28-PET in People with Neurogenerative Disease

Study Purpose:

The purpose of the study is to learn more about inflammation in the brains of people with Motor Neuron Disease (MND) using combined Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET).

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS, Primary Lateral Sclerosis (PLS), Hereditary Spastic Paraplegia (HSP), Healthy Volunteer, Healthy Volunteer with a Family History of ALS

Study Type:

Observational Study

Study Category:

Biomarkers/Imaging

Study Status:

Enrolling

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Suma Babu, Massachusetts General Hospital

Clinicaltrials.gov ID (11 digit #):

N/A

Neals Affiliated?

No

Coordinating Center Contact Information

Massachusetts General Hospital
Catherine Cebulla / .(JavaScript must be enabled to view this email address) / 617-643 6252
.(JavaScript must be enabled to view this email address) 165 Cambridge St.
Suite 600
Boston, Massachusetts 02114 United States

Full Study Summary:

Massachusetts General Hospital is seeking individuals to participate in a research study enrolling under the direction of Nazem Atassi, MD, MMSc. The purpose of the study is to learn more about inflammation in the brains of people with Motor Neuron Disease (MND) using combined Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET). Our study will examine whether particular cells, called microglia, are hyperactive in the nervous system of people with MND, such as those individuals with Amyotrophic Lateral Sclerosis (ALS). This information could help improve the diagnosis and development of treatments for other patients with MND in the future.

This study aims to enroll the following cohorts of individuals:

  • Individuals with a diagnosis of MND: ALS, Primary Lateral Sclerosis (PLS), Hereditary Spastic Paraplegia (HSP)
  • Healthy individuals who are known carriers of an ALS gene such as chromosome 9 open reading frame 72 (C9orf72) or superoxide dismutase 1 (SOD1)
  • Individuals with a diagnosis of Frontotemporal Dementia (FTD)
  • Healthy individuals without any neurodegenerative disease and no family history of MND

Study participation involves two visits to MGH over a maximum of three months (these visits can also be completed in one day). During the visit(s), participants will undergo a 90-minute MR-PET scan. Participants with MND will also undergo a breathing test, muscle test and questionnaires, and may choose to participate in an optional lumbar puncture (not to be completed on the same day as the scan). Individuals with MND may elect to participate for up to four years in up to 9 optional follow-up scans approximately every three months for the first year and every six months for the following three years. Individuals who do not have MND but are known ALS gene carriers may elect to participate in up to 7 optional follow-up scans approximately every six months for up to four years.

Participants must be between the ages of 18 and 80, be medically safe to undergo an MRI scan (i.e., no metallic particles in the body), and be able to safely lie flat for at least 90 minutes. Additionally, participants cannot be taking any immunosuppressive medications or have a diaphragm pacing system and cannot have a diagnosis of Parkinson’s disease, Alzheimer’s disease, unstable psychiatric disease, or renal failure.

All participants will be reimbursed for parking and receive compensation of $150 upon completion of each MR-PET scan. There will be additional compensation of $100 for each lumbar puncture completed by individuals with MND.

Study Sponsor:

Muscular Dystrophy Association, NIH, Voyager

Participant Duration:

Study participation involves two visits to MGH over a maximum of three months (these visits can also be completed in one day). During the visit(s), participants will undergo a 90-minute MR-PET scan. Participants with MND will also undergo a breathing test, muscle test and questionnaires, and may choose to participate in an optional lumbar puncture (not to be completed on the same day as the scan). Individuals with MND may elect to participate for up to four years in up to 9 optional follow-up scans approximately every three months for the first year and every six months for the following three years. Individuals who do not have MND but are known ALS gene carriers may elect to participate in up to 7 optional follow-up scans approximately every six months for up to four years. 

Estimated Enrollment:

300

Estimated Study Start Date:

02/28/2018

Estimated Study Completion Date:

Posting Last Modified Date:

02/05/2019

Date Study Added to alsconsortium.org:

04/10/2018
  • 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


  • Site Contact Information

    Massachusetts General Hospital
    Catherine Cebulla / .(JavaScript must be enabled to view this email address) / 617-643 6252
    165 Cambridge St.
    Boston, Massachusetts 02114
    United States