An Open Label, Single Center Study to Evaluate the Safety and Test-retest Characteristics of [18F]PI-2620 as PET Radioligand for Imaging Tau Deposition in the Brains of Patients With Progressive Supranuclear Palsy Richardson Syndrome (PSP-RS) Compared to Non-demented Controls (NDC)
The overall goal of this protocol is to evaluate the imaging characteristics of [18F]PI-2620 using positron emission tomography (PET) in patients with progressive supranuclear palsy, Richardson's syndrome (PSP-RS)
• Males and females aged 50-80 years
• Able to understand, sign and date written informed consent
• Signed and dated written informed consent obtained from the subject
• The subject has an appropriate caregiver capable of accompanying subject, if necessary
• Have an Montreal Cognitive Assessment (MoCa) score ≥ 27
• Female subjects must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or post-menopausal for at least 1 year (no menses for 12 months without an alternative medical cause). If they are of child-bearing potential, must commit to use of a highly effective contraceptive measure for the duration of the study
• Male subjects and their partners of childbearing potential must commit to the use of a highly effective method of contraception for a minimum of 90 days following each PET scan
• Male subjects must commit to not donate sperm for a minimum of 90 days after each PET scan
• Willing and able to cooperate with study procedures including lying flat and still on the scanning bed for 60 minutes
• Healthy with no clinically relevant finding on physical examination at screening
• No cognitive impairment from neuropsychological battery as judged by the investigator
• A brain MRI without evidence of significant neurological pathology
• A beta-amyloid Neuraceq® PET demonstrating a negative beta-amyloid status
• No signs of movement disorder as judged by Progressive Supranuclear Palsy Rating Scale (PSPRS), Movement Disorder Society - Unified Parkinson's Disability Rating Scale (MDS-UPDRS) and Progressive Supranuclear Palsy Clinical Deficits Scale (PSP-CDS)
• Patients with a clinical diagnosis of probable PSP-RS based on the Movement Disorder Society criteria (Höglinger et al., 2017)
• Medications taken for symptomatic treatment of PSP must be maintained on a stable dosage regimen for at least 30 days before the [18F]PI-2620 PET imaging visits