Imaging neuroinflammation in frontotemporal dementia

Molecular Neuroimaging of Neuroinflammation in Neurodegenerative Dementias

This study is testing a new imaging technique to see how inflammation in the brain affects people with frontotemporal dementia and how it varies among different types of the condition.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 30 Years to 95 Years
• Sex: All
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (London, Ontario)
• Trial ID: NCT02945774 on ClinicalTrials.gov

What this trial studies

This study evaluates neuroinflammation in patients with frontotemporal dementia (FTD) using hybrid PET/MRI imaging techniques. It aims to assess the relationship between neuroinflammation, cerebral perfusion, and brain structure in FTD patients. Participants will undergo neurocognitive assessments and imaging with the PET ligand FEPPA, which targets activated microglia, a marker of neuroinflammation. The study will also explore differential patterns of neuroinflammation across various clinical and molecular subtypes of FTD.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with probable frontotemporal dementia or neurologically healthy controls without a history of neurological issues.

Not a fit: Patients with significant neurological diseases other than suspected frontotemporal dementia may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of neuroinflammation in FTD, potentially leading to improved diagnostic and therapeutic strategies.

How similar studies have performed: While the approach of using PET/MRI imaging for neuroinflammation is gaining traction, this specific application in frontotemporal dementia is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Patients diagnosed with a probable Frontotemporal Dementia or neurologically healthy control participants with no history of neurological problems
2. 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.
3. Visual and auditory acuity adequate for neuropsychological testing
4. Good general health with no diseases expected to interfere with the study.
5. 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
6. Willing to participate in a longitudinal imaging study at 12 months.
7. Willing to undergo MRI (3Tesla)/ PET scan (with FEPPA ligand) and no medical contraindications to MRI.

Exclusion Criteria:

1. Any significant neurologic disease other than suspected Frontotemporal Dementia that would better account for symptoms (i.e. frontal lobe stroke).
2. Screening/baseline MRI scans with evidence of infection, infarction, or other focal lesions. Subjects with multiple lacunes are excluded.
3. 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.
4. 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.
5. History of schizophrenia (DSM IV criteria).
6. Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol.
7. Clinically significant abnormalities in B12, or thyroid function tests that might interfere with the study.
8. Investigational agents are prohibited one month prior to entry and for the duration of the trial.
9. 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).
10. 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.

Where this trial is running

London, Ontario

• Parkwood Institute — London, Ontario, Canada (Recruiting)

Study contacts

• Study coordinator: S Jesso, BA

Conditions Frontotemporal Dementia; PET; MRI; Inflammation; Microglia; FEPPA