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 range
50 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.