Molecular Neuroimaging of Neuroinflammation in Neurodegenerative Dementias

NCT02945774 | Recruiting DMC

• 1 other identifier: 107561
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Frontotemporal Dementia

Keywords

PET; MRI; Inflammation; Microglia; FEPPA

Outcome Measures

Primary Outcomes (1)

• Group differences in regional PET FEPPA ligand imaging

  120 Minutes

Secondary Outcomes (1)

• Correlation between PET FEPPA ligand images and specified MR images

  120 Minutes

Study Arms (1)

(18F)-FEPPA

EXPERIMENTAL

Radiation: (18F)-FEPPA

Interventions

(18F)-FEPPA RADIATION

PET ligand that binds to activated microglia, a marker of neuroinflammation

(18F)-FEPPA

Eligibility Criteria

• Age: 30 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

Parkwood Institute

London, Ontario, N6C 0A7, Canada

RECRUITING

MeSH Terms

Conditions

Frontotemporal Dementia; Inflammation

Interventions

N-(2-((N-(4-phenoxypyridin-3-yl)acetamido)methyl)phenoxy)ethyl fluoride

Condition Hierarchy (Ancestors)

Frontotemporal Lobar Degeneration; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; TDP-43 Proteinopathies; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

S Jesso, BA

CONTACT

519-646-6000; cognitiveneurology@sjhc.london.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: October 26, 2016
• Study Start: August 1, 2016
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: March 5, 2025

Record last verified: 2025-03

Locations

CA (1)