Evaluation of Imaging Characteristics of [18F]PI-2620 PET in AD and PSP Patients Using High and L… (NCT04715750) | Clinical Trial Compass
CompletedPhase 1
Evaluation of Imaging Characteristics of [18F]PI-2620 PET in AD and PSP Patients Using High and Low Specific Activity
Germany10 participantsStarted 2020-11-12
Plain-language summary
This is an open-label study without randomisation. All eligible patients will receive two administrations of the investigational imaging agent \[18F\]PI-2620 at a radioactive dose of 185 MBq, one with high specific activity (≤ 5 µg tracer mass dose), another one with low specific activity (40-50 µg tracer mass dose).
Who can participate
Age range50 Years – 80 Years
SexALL
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Inclusion Criteria:
* Males and females aged 50-80 years
* Able to understand, sign and date written informed consent, which is confirmed by the judgment of the referring physician
* Written informed consent must be obtained before any assessment is performed
* Prior evaluable MRI
* Female patients 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 patients and their partners of childbearing potential must commit to the use of a highly effective method of contraception for a minimum of one week following each PET scan
* Male patients must commit to not donate sperm for a minimum of one week after each PET scan.
Inclusion Criteria for mild-moderate AD patients
* Patients with mild or moderate AD in accordance with NIA-AA guidelines 2011
* Have a CDR score of ≥ 0.5 at screening
* Have an MMSE score of ≤ 24 at screening
* Prior evaluable amyloid PET imaging confirming presence of beta-amyloid brain pathology
* Medications taken for symptomatic treatment of AD must be maintained on a stable dosage regimen for at least 30 days before the \[18F\]PI-2620 PET imaging visits
Inclusion Criteria for patients with probable PSP
* …
What they're measuring
1
Comparability of visual assessment of PI-2620 tau PET images obtained after injection of high specific activity and low specific activity in AD and PSP patients.