Frontotemporal DementiaNCT02945774
Molecular Neuroimaging of Neuroinflammation in Neurodegenerative Dementias
A study testing (18F)-FEPPA in people with Frontotemporal Dementia, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Frontotemporal Dementia
- What is being tested?
- (18F)-FEPPA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2016to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Parkwood Institute
London, Ontario, N6C 0A7
S Jesso, BA, 519-646-6000
About this study
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
- Being tested
- (18F)-FEPPA
- Keywords
- PET, MRI, Inflammation, Microglia, FEPPA
- Medical subject headings
- Frontotemporal Dementia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(18F)-FEPPARadiation
PET ligand that binds to activated microglia, a marker of neuroinflammation
| Study group | Role | What they receive |
|---|---|---|
| (18F)-FEPPA | Experimental | Not described Receives: Radiation: (18F)-FEPPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group differences in regional PET FEPPA ligand imaging
Measured: 120 Minutes
Secondary outcomes (1)
Correlation between PET FEPPA ligand images and specified MR images
Measured: 120 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startAug 2016
- Primary completionFeb 2028 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frontotemporal DementiaStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945774
- Sponsor's protocol ID
- 107561
- Status last verified
- Mar 2025
- First submitted
- 25 Oct 2016
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Neuroimaging of Neuroinflammation in Neurodegenerative Dementias
- ClinicalTrials.gov ID
- NCT02945774
- Acronym / sponsor ID
- 107561
- Conditions
- Frontotemporal Dementia
- Keywords
- PET, MRI, Inflammation, Microglia, FEPPA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| (18F)-FEPPA | Experimental | Radiation: (18F)-FEPPA |
Who may qualify
- Ages
- 30 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (18F)-FEPPAPET ligand that binds to activated microglia, a marker of neuroinflammation | Radiation | (18F)-FEPPA |
Primary outcome
Group differences in regional PET FEPPA ligand imaging
Time frame: 120 Minutes
1 secondary outcome
Correlation between PET FEPPA ligand images and specified MR images
Time frame: 120 Minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (18F)-FEPPA in people with Frontotemporal Dementia, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact S Jesso, BA (519-646-6000, cognitiveneurology@sjhc.london.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Group differences in regional PET FEPPA ligand imaging (time frame: 120 Minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.