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 ALSStudy Type:
Observational StudyStudy Category:
Biomarkers/ImagingStudy Status:
EnrollingPhase:
Not ApplicableStudy Chair(s)/Principal Investigator(s):
Suma Babu, Massachusetts General Hospital
Clinicaltrials.gov ID (11 digit #):
N/ANeals Affiliated?
NoCoordinating Center Contact Information
Massachusetts General HospitalAustin Lewis / .(JavaScript must be enabled to view this email address) / 617-724-7928
Mackenzie Keegan / .(JavaScript must be enabled to view this email address) / 617-643-6252
165 Cambridge Street
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 Suma Babu, MD. 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, VoyagerParticipant 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.