Clinical trial for Frontotemporal Dementia
Official title Molecular Neuroimaging of Neuroinflammation in Neurodegenerative Dementias
ClinicalTrials.gov ID: NCT02945774
What this study is testing
- What it's testing
- Researchers want to see if brain inflammation is present in frontotemporal dementia and how it differs among its subtypes. They also want to know how inflammation relates to blood flow and brain structure.
- Who it's for
- The study is looking for adults who have been diagnosed with frontotemporal dementia.
- What's involved
- Participants will have a brain scan that combines PET and MRI. The PET scan uses a special tracer that sticks to activated microglia, cells that signal inflammation. They will also get a cognitive test and other MRI measurements of brain blood flow and structure.
- Time commitment
- The study involves a single visit that includes the scans and tests, lasting a few hours.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 95. Healthy volunteers may be eligible.
You may be able to join 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...
- 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.
You likely can't join 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. people 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...
- Major depression, bipolar disorder as described in DSM-IV within the past 1 year.
- History of schizophrenia (DSM IV criteria).
- Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol.
See the full eligibility 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.
- 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. people 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...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- London, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 95 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at London, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.