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Quantification tools for a novel tau PET marker in a rare neurological disease: 18F-PI-2620 in progressive supranuclear palsy
EU CTIS ID: 2023-508718-40-00
What this study is testing
To analyze differences in in vivo regional tau uptake (quantified by PET-PI-2620) between participants with a diagnosis suggestive of PSP (soPSP), patients with a probable diagnosis of PSP, patients with Parkinson's disease, and controls without neurological pathology.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients of both sexes aged between 40 and 80 years.
- The subject must be able to comply with the protocols and procedures necessary for the development of the clinical trial.
- Consent of the subject or his/her legal representative to voluntarily participate in the study by signing the informed consent.
- In women, postmenopausal status (one year without menstruation without other medical causes) or negative pregnancy test. Subjects (women and male partners of participants) of childbearing age must agree to a commitment to practice sexual abstinence or use highly effective contraceptive methods (hormonal contraceptives that inhibit ovulation, IUDs, surgical sterilization) from their inclusion in the study until one month after the PET scan.
- Magnetic resonance imaging (MRI) study of the brain to rule out any other type of relevant neurological pathology.
- PSP population: Have a clinical diagnosis of soPSP or probable PSP according to current diagnostic criteria (Höglinger et al. 2017)
You likely can't join if
- Diagnosis of relevant central nervous system disease such as Huntington's disease, normotensive hydrocephalus, cerebrovascular disease, frontotemporal dementia, Alzheimer's disease, history of major or recurrent head trauma, history of epilepsy or seizures (except febrile seizures in childhood without antiepileptic medication at present).
- Legal incapacity and/or circumstances that prevent the subject or his/her legal representatives from understanding the nature, objectives and possible consequences of the trial.
- Treatment with any other investigational medicinal products within 30 days prior to inclusion.
- PSP population: Diagnosis or suspicion of any Parkinsonian syndrome other than PSP such as idiopathic Parkinson's disease, pharmacological parkinsonism, essential tremor, primary dystonias, or any other cause that may produce symptoms similar to those of Parkinson's disease.
- Presence of terminal illnesses or illnesses that may put the patient's health at risk from participating in the study or influencing the results of the study or the patient's ability to participate in the study.
- Abuse of alcohol or other legal or illegal drugs (except nicotine).
See the full eligibility criteria
Who can join
- Patients of both sexes aged between 40 and 80 years.
- The subject must be able to comply with the protocols and procedures necessary for the development of the clinical trial.
- Consent of the subject or his/her legal representative to voluntarily participate in the study by signing the informed consent.
- In women, postmenopausal status (one year without menstruation without other medical causes) or negative pregnancy test. Subjects (women and male partners of participants) of childbearing age must agree to a commitment to practice sexual abstinence or use highly effective contraceptive methods (hormonal contraceptives that inhibit ovulation, IUDs, surgical sterilization) from their inclusion in the study until one month after the PET scan.
- Magnetic resonance imaging (MRI) study of the brain to rule out any other type of relevant neurological pathology.
- PSP population: Have a clinical diagnosis of soPSP or probable PSP according to current diagnostic criteria (Höglinger et al. 2017)
- Parkinson population: Have a clinical diagnosis of soPSP or probable PSP according to current diagnostic criteria (Postuma et .a, 2015)
- Control population: Absence of clinical history of neuropsychiatric diseases.
What rules you out
- Diagnosis of relevant central nervous system disease such as Huntington's disease, normotensive hydrocephalus, cerebrovascular disease, frontotemporal dementia, Alzheimer's disease, history of major or recurrent head trauma, history of epilepsy or seizures (except febrile seizures in childhood without antiepileptic medication at present).
- Legal incapacity and/or circumstances that prevent the subject or his/her legal representatives from understanding the nature, objectives and possible consequences of the trial.
- Treatment with any other investigational medicinal products within 30 days prior to inclusion.
- PSP population: Diagnosis or suspicion of any Parkinsonian syndrome other than PSP such as idiopathic Parkinson's disease, pharmacological parkinsonism, essential tremor, primary dystonias, or any other cause that may produce symptoms similar to those of Parkinson's disease.
- Presence of terminal illnesses or illnesses that may put the patient's health at risk from participating in the study or influencing the results of the study or the patient's ability to participate in the study.
- Abuse of alcohol or other legal or illegal drugs (except nicotine).
- Pregnancy.
- Known allergy to PI-2620 or any of the other components of the radiopharmaceutical.
- Any contraindication or impediment to the performance of the PET/CT study with PI-2620.
- Subjects who are not able to understand and/or comply with the necessary guidelines for the conduct of the trial (e.g.: interrogation, physical examination, lumbar puncture, attending visits, etc.) and that they do not have responsible companions who understand and commit to comply with these guidelines.
- Subjects who do not cooperate or are unable to comply with the procedures required for this clinical trial, such as (but not limited to): social disorders that anticipate an obvious lack of cooperation, psychopathy, drug or alcohol abuse.
- Subjects or their legal representatives who do not sign the informed consent.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.