Test-retest Study With [18F]PI-2620 in PSP-RS and NDC (NCT05187546) | Clinical Trial Compass
CompletedPhase 1
Test-retest Study With [18F]PI-2620 in PSP-RS and NDC
Germany15 participantsStarted 2022-03-10
Plain-language summary
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)
Who can participate
Age range50 Years – 80 Years
SexALL
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Inclusion Criteria (for all subjects)
* 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
Inclusion criteria for non-demented controls (NDC)
* 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 demonstr…
What they're measuring
1
Test-retest variability of the [18F]PI-2620 binding parameters in brain of patients with PSP-RS and non-demented controls
Timeframe: The duration of the study for participants may be up to 74 days
2
Number of adverse events
Timeframe: The duration of the study for participants may be up to 74 days