Phase
Condition
Dementia
Memory Loss
Frontotemporal Dementia
Treatment
(18F)-FEPPA
Clinical Study ID
Ages 30-95 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients diagnosed with a probable Frontotemporal Dementia or neurologically healthycontrol participants with no history of neurological problems
Study partner is available who has frequent contact with the subject and canaccompany 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 betwo years post-menopausal, surgically sterile or practicing an effective form offamily planning
Willing to participate in a longitudinal imaging study at 12 months.
Willing to undergo MRI (3Tesla)/ PET scan (with FEPPA ligand) and no medicalcontraindications to MRI.
Exclusion
Exclusion Criteria:
Any significant neurologic disease other than suspected Frontotemporal Dementia thatwould better account for symptoms (i.e. frontal lobe stroke).
Screening/baseline MRI scans with evidence of infection, infarction, or other focallesions. Subjects with multiple lacunes are excluded.
Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metalfragments or foreign objects in the eyes, skin or body that may preclude MRIparticipation 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 whichcould lead to difficulty complying with the protocol.
History of schizophrenia (DSM IV criteria).
Any significant systemic illness or unstable medical condition which could lead todifficulty complying with the protocol.
Clinically significant abnormalities in B12, or thyroid function tests that mightinterfere with the study.
Investigational agents are prohibited one month prior to entry and for the durationof the trial.
Exclusion for FEPPA: Current or recent participation in any procedures involvingradioactive agents such that the total radiation dose exposure to the subject in anygiven year would exceed the limits of annual and total dose commitment set forth.The current regulation for radiation dose to patient volunteers and health controlvolunteers are contained within Health Canada's recently amended (June 19, 2012)Regulations Amending the Food and Drug Regulations (Positron-emittingRadiopharmaceuticals). 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 inINFO-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 collateralflow, Infection at the cannulation site, Previous surgery in the area, Syntheticvascular graft.
Study Design
Connect with a study center
Parkwood Institute
London, Ontario N6C 0A7
CanadaActive - Recruiting
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