Testing (18F)-FEPPA for frontotemporal dementia
Official title: Molecular Neuroimaging of Neuroinflammation in Neurodegenerative Dementias
Interventions
(18F)-FEPPA
PET ligand that binds to activated microglia, a marker of neuroinflammation
Canadian Sites (1)
Parkwood Institute
London, Ontario, Canada
Eligibility Criteria
See who this study is looking for17 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Patients diagnosed with a probable Frontotemporal Dementia or neurologically healthy controlControl groupThe group a new treatment is measured against.Read more → 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 protocolProtocolThe detailed plan a study must follow.Read more →.
- +Visual and auditory acuity adequate for neuropsychological testing
- +Good general health with no diseases expected to interfere with the study.
- +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.
- +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
Exclusion
- −Any significant neurologic disease other than suspected Frontotemporal Dementia that would better account for symptoms (i.e. frontal lobe stroke).
- −ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →/baselineBaselineYour starting measurements, taken before treatment begins.Read more → 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 protocolProtocolThe detailed plan a study must follow.Read more →.
- −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.
- −ExclusionExclusion criteriaThe things that would prevent someone from taking part.Read more → 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 controlControl groupThe group a new treatment is measured against.Read more → 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 siteTrial siteA hospital or clinic where a study is actually run.Read more →, 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.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to identify or measure a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: (18F)-FEPPA.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There is one group in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 30 years to 95 years.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 40 people.
The study is currently expected to finish around August 2029.
The main measurement is taken over: 120 Minutes.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Group differences in regional PET FEPPA ligand imaging — measured over 120 Minutes.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT02945774 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About (18F)-FEPPARadiation
PET ligand that binds to activated microglia, a marker of neuroinflammation
From the trial registry — its own words, unedited.
What a radiation is here: A form of radiotherapy or radiation-based treatment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 30 years to 95 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 30 years to 95 years.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 120 Minutes.
The study as a whole is currently expected to finish around 2029-08.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 40 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: London, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.