Molecular Neuroimaging of Neuroinflammation in Neurodegenerative Dementias
Primary Purpose
Frontotemporal Dementia
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
(18F)-FEPPA
Sponsored by
About this trial
This is an interventional diagnostic trial for Frontotemporal Dementia focused on measuring PET, MRI, Inflammation, Microglia, FEPPA
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed with a probable Frontotemporal Dementia or neurologically healthy control participants with no history of neurological problems
- Study partner is available who has frequent contact with the subject and can accompany the subject to all clinic visits for the duration of the protocol.
- Visual and auditory acuity adequate for neuropsychological testing
- Good general health with no diseases expected to interfere with the study.
- Subject is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal, surgically sterile or practicing an effective form of family planning
- Willing to participate in a longitudinal imaging study at 12 months.
- Willing to undergo MRI (3Tesla)/ PET scan (with FEPPA ligand) and no medical contraindications to MRI.
Exclusion Criteria:
- Any significant neurologic disease other than suspected Frontotemporal Dementia that would better account for symptoms (i.e. frontal lobe stroke).
- Screening/baseline MRI scans with evidence of infection, infarction, or other focal lesions. Subjects with multiple lacunes are excluded.
- Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body that may preclude MRI participation as per MRI screening form.
- Major depression, bipolar disorder as described in DSM-IV within the past 1 year. Psychotic features, agitation or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol.
- History of schizophrenia (DSM IV criteria).
- Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol.
- Clinically significant abnormalities in B12, or thyroid function tests that might interfere with the study.
- Investigational agents are prohibited one month prior to entry and for the duration of the trial.
- Exclusion for FEPPA: Current or recent participation in any procedures involving radioactive agents such that the total radiation dose exposure to the subject in any given year would exceed the limits of annual and total dose commitment set forth. The current regulation for radiation dose to patient volunteers and health control volunteers are contained within Health Canada's recently amended (June 19, 2012) Regulations Amending the Food and Drug Regulations (Positron-emitting Radiopharmaceuticals). Limitations for effective total body dose is 50 mSv (C.03.305 (c)) which has been increased from the previous values of 20 mSv (Table 1 in INFO-0491).
- Exclusion Criteria for controls undergoing arterial line placement: Absent pulse, Thromboangiitis obliterans (Buerger disease), Burns over the cannulation site, Inadequate circulation to the extremity, Raynaud syndrome, Anticoagulation therapy, Atherosclerosis of upper extremity vessels, Coagulopathy, inadequate collateral flow, Infection at the cannulation site, Previous surgery in the area, Synthetic vascular graft.
Sites / Locations
- Parkwood InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
(18F)-FEPPA
Arm Description
Outcomes
Primary Outcome Measures
Group differences in regional PET FEPPA ligand imaging
Secondary Outcome Measures
Correlation between PET FEPPA ligand images and specified MR images
Full Information
NCT ID
NCT02945774
First Posted
October 25, 2016
Last Updated
March 16, 2023
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02945774
Brief Title
Molecular Neuroimaging of Neuroinflammation in Neurodegenerative Dementias
Official Title
Molecular Neuroimaging of Neuroinflammation in Neurodegenerative Dementias
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2016 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Neuroinflammation is increasingly implicated as a potential critical pathogenic mechanism in a variety of neurologic and psychiatric disorders. This study will use hybrid PET/MRI imaging to evaluate neuroinflammation and its relationship to cerebral perfusion in frontotemporal dementia (FTD). Patients with FTD will be recruited from the Cognitive Neurology and Aging Brain clinics at Parkwood Institute and will undergo neurocognitive assessment and MRI/PET using the PET ligand FEPPA which binds to activated microglia, a marker of neuroinflammation. Correlations will be conducted to determine whether abnormal neuroinflammation is present in Frontotemporal dementia and whether differential patterns of neuroinflammation are present in different FTD clinical and molecular subtypes, and to determine the relationship between neuroinflammation, cerebral perfusion using arterial spin labeling MRI imaging techniques, and indices of brain structure including volumetric and white matter analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frontotemporal Dementia
Keywords
PET, MRI, Inflammation, Microglia, FEPPA
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
(18F)-FEPPA
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
(18F)-FEPPA
Intervention Description
PET ligand that binds to activated microglia, a marker of neuroinflammation
Primary Outcome Measure Information:
Title
Group differences in regional PET FEPPA ligand imaging
Time Frame
120 Minutes
Secondary Outcome Measure Information:
Title
Correlation between PET FEPPA ligand images and specified MR images
Time Frame
120 Minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with a probable Frontotemporal Dementia or neurologically healthy control participants with no history of neurological problems
Study partner is available who has frequent contact with the subject and can accompany the subject to all clinic visits for the duration of the protocol.
Visual and auditory acuity adequate for neuropsychological testing
Good general health with no diseases expected to interfere with the study.
Subject is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal, surgically sterile or practicing an effective form of family planning
Willing to participate in a longitudinal imaging study at 12 months.
Willing to undergo MRI (3Tesla)/ PET scan (with FEPPA ligand) and no medical contraindications to MRI.
Exclusion Criteria:
Any significant neurologic disease other than suspected Frontotemporal Dementia that would better account for symptoms (i.e. frontal lobe stroke).
Screening/baseline MRI scans with evidence of infection, infarction, or other focal lesions. Subjects with multiple lacunes are excluded.
Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body that may preclude MRI participation as per MRI screening form.
Major depression, bipolar disorder as described in DSM-IV within the past 1 year. Psychotic features, agitation or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol.
History of schizophrenia (DSM IV criteria).
Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol.
Clinically significant abnormalities in B12, or thyroid function tests that might interfere with the study.
Investigational agents are prohibited one month prior to entry and for the duration of the trial.
Exclusion for FEPPA: Current or recent participation in any procedures involving radioactive agents such that the total radiation dose exposure to the subject in any given year would exceed the limits of annual and total dose commitment set forth. The current regulation for radiation dose to patient volunteers and health control volunteers are contained within Health Canada's recently amended (June 19, 2012) Regulations Amending the Food and Drug Regulations (Positron-emitting Radiopharmaceuticals). Limitations for effective total body dose is 50 mSv (C.03.305 (c)) which has been increased from the previous values of 20 mSv (Table 1 in INFO-0491).
Exclusion Criteria for controls undergoing arterial line placement: Absent pulse, Thromboangiitis obliterans (Buerger disease), Burns over the cannulation site, Inadequate circulation to the extremity, Raynaud syndrome, Anticoagulation therapy, Atherosclerosis of upper extremity vessels, Coagulopathy, inadequate collateral flow, Infection at the cannulation site, Previous surgery in the area, Synthetic vascular graft.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
S Jesso, BA
Phone
519-646-6000
Email
cognitiveneurology@sjhc.london.on.ca
Facility Information:
Facility Name
Parkwood Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 0A7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S Jesso, BA
Phone
519-646-6000
12. IPD Sharing Statement
Learn more about this trial
Molecular Neuroimaging of Neuroinflammation in Neurodegenerative Dementias
We'll reach out to this number within 24 hrs