Healthy Volunteers, Progressive Supranuclear Palsy
Conditions
Keywords
PSP, HV
Brief summary
The overall goal of this protocol is to evaluate \[18F\]APN-1607 as a PET radiotracer for measuring longitudinal change in tau pathology in participants with PSP.
Detailed description
The overall goal of this protocol is to evaluate \[18F\]APN-1607 as a PET radiotracer for measuring longitudinal change in tau pathology in participants with PSP. The specific objectives are: * To characterize and demonstrate the longitudinal progression of tau deposition in vivo in participants with PSP. * To determine optimal PET analysis parameters for \[18F\]APN-1607 quantification. * To characterize the stability of tau deposition in vivo over time in healthy volunteers (HVs). * To evaluate consistency of \[18F\]APN-1607 quantification in characterizing tau deposition.
Interventions
DRUG[18F] APN-1607
Subjects will undergo PET imaging using \[18F\]APN-1607.
Sponsors
Invicro
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
for all participants: * Males or females from 50 to 80 years of age at Screening, inclusive. * Body weight range of ≥ 43 kg to ≤ 120 kg. * Score ≥20 on the MMSE at Screening. * For women of childbearing potential, agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs, as defined below: * A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (ie, removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the Investigator (eg, Müllerian agenesis). The definition of childbearing potential may be adapted for alignment with local guidelines or regulations. * Women of childbearing potential must remain abstinent or use 2 methods of contraception, one of which is a barrier method (ie, male or female condom), for the study duration and 30 days after the last dose. * Male participants with partners of childbearing potential must commit to the use of 2 methods of contraception, one of which is a barrier method (ie, male condom with or without spermicidal jelly), for the study duration and 90 days after the last dose. * Male participants must not donate sperm for the duration of the study and 90 days after the last dose. * For participants receiving arterial cannulation, adequate circulation to the hand for safe placement of arterial line (as determined by Allen's test) and blood clotting (prothrombin time and partial thromboplastin time \[PT & PTT\]). Additional Inclusion Criteria for HVs * Understand the study procedures and agree to participate by providing written informed consent. * Healthy with no clinically relevant finding on physical examination at Screening. * No cognitive impairment based on neuropsychological testing, as judged by the Investigator. * No family history of neurological disease associated with dementia. Additional Inclusion Criteria for Participants with PSP * Agree to participate by providing written informed consent or written assent with informed consent from the participant's LAR or caregiver. * Has a clinical diagnosis of probable PSP based on the National Institute of Neurological Disorders and Stroke and the Society for PSP (NINDS-SPSP) criteria (Litvan, et al 1996). * Have Screening or prior DaTscan SPECT imaging demonstrating evidence of DaT deficit, based on visual read. * A brain MRI scan that supports a diagnosis of PSP, with no other evidence of significant neurologic pathology. * Deemed by the opinion of the Principal Investigator to be physically able to participate in all visits throughout the duration of the trial. * Medications taken for symptomatic treatment of PSP should be maintained on a stable dosage regimen for at least 30 days before Screening, if possible. * The participant has an appropriate caregiver capable of accompanying participant, if applicable.
Exclusion criteria
for all participants: * Participants are only eligible if they do not fulfill any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in standardized uptake value ratios (SUVRs) of regional [18F]APN-1607. | 72 weeks | The within-group change in standardized uptake value ratios (SUVRs) of regional \[18F\]APN-1607 binding within a priori defined cortical and subcortical brain regions from Baseline to Week 36 and Week 72. |
Countries
United States
Outcome results
None listed