About this trial
Imaging PDE4B in people with psychiatric disorders with PET and the radiotracer \[18F\]PF974
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Willing and able to give voluntary written informed consent.
Is able to read and write, able to communicate effectively with the investigator, and comply with all study requirements, restrictions, and directions of the research staff.
Men or women, aged 18 to 70, at screening.
In good general health as evidenced by medical history, physical examination, electrocardiogram, serum/urine biochemistry, hematology, and serology tests.
Disqualifiers
Current significant medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology that would impact the integrity of the data (note that elevated liver enzymes for individuals with AUD will not be exclusionary).
Past or current neurological disorder or disorders affecting the brain including but not limited to multiple sclerosis, history of stroke, brain tumors, traumatic brain injury with loss of consciousness, seizure disorder.
Current significant psychiatric disorder including severe substance use disorder (other than alcohol or tobacco use disorders*) and past or current psychotic symptoms.
Regular use in the past 6 months of any prescription, psychoactive or herbal medications (e.g., antidepressants, antipsychotics, anxiolytics) that would impact the integrity of the data; No subject will be asked to stop taking medication to participate in the study. Participants who are regularly taking P-gp and BCRP inhibitors will be excluded.
Trial population
Up to 40 AUD subjects may be enrolled. Up to 40 PTSD subjects may be enrolled. Up to 40 HC subjects may be enrolled. Up to 40 TC subjects may be enrolled.
Trial design
Case-control
Prospective
Treatments tested in this trial
PF974
DrugPF974 Radiotracer.
Treatment groups
Trial outcomes
Primary outcomes
Regional [18F]PF974 volume of distribution (VT)
proportional to the levels of PDE4B available for radiotracer binding
Secondary outcomes
Secondary Region Of Interest (ROI) Binding of [18F]PF974
Ventromedial and dorsolateral prefrontal cortex; the insula, occipital, parietal, and temporal cortices; amygdala, and thalamus.
Sponsors and contacts
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