IZAFLORTAUCIPIR (18F) for Progressive supranuclear palsy | Parkinson's disease

Inclusion criteria

• {"criterion_text":"- Patients of both sexes aged between 40 and 80 years."}
• {"criterion_text":"- The subject must be able to comply with the protocols and procedures necessary for the development of the clinical trial."}
• {"criterion_text":"- Consent of the subject or his/her legal representative to voluntarily participate in the study by signing the informed consent."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Magnetic resonance imaging (MRI) study of the brain to rule out any other type of relevant neurological pathology."}
• {"criterion_text":"- PSP population: Have a clinical diagnosis of soPSP or probable PSP according to current diagnostic criteria (Höglinger et al. 2017)"}
• {"criterion_text":"- Parkinson population: Have a clinical diagnosis of soPSP or probable PSP according to current diagnostic criteria (Postuma et .a, 2015)"}
• {"criterion_text":"- Control population: Absence of clinical history of neuropsychiatric diseases."}

Exclusion criteria

• {"criterion_text":"- 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)."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Treatment with any other investigational medicinal products within 30 days prior to inclusion."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Abuse of alcohol or other legal or illegal drugs (except nicotine)."}
• {"criterion_text":"- Pregnancy."}
• {"criterion_text":"- Known allergy to PI-2620 or any of the other components of the radiopharmaceutical."}
• {"criterion_text":"- Any contraindication or impediment to the performance of the PET/CT study with PI-2620."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Subjects or their legal representatives who do not sign the informed consent."}

Primary endpoints

• {"endpoint_text":"- PI-2620 uptake determined by standard uptake value ratio (SUVR)","definition_or_measurement_approach":"Determined by standard uptake value ratio (SUVR) as stated in endpoint description."}

Secondary endpoints

• {"endpoint_text":"- SUVR of the base nuclei divided a reference region such as the brain stem.","definition_or_measurement_approach":"SUVR of basal nuclei using a reference region such as the brain stem."}
• {"endpoint_text":"- SUVR of the cerebral cortex divided into a reference region such as the brain stem.","definition_or_measurement_approach":"SUVR of cerebral cortex using a reference region such as the brain stem."}
• {"endpoint_text":"- Association of PI-2620 uptake values with demographics, clinical variables and CSF biomarkers","definition_or_measurement_approach":"Correlation/association analyses between PI-2620 SUVR uptake values and demographic, clinical variables and CSF biomarkers (4R-tau and NfL) as described in objectives."}

Spain

Earliest CTIS Part Ii Submission Date

15-01-2024

Latest Decision Or Authorization Date

05-03-2024

Processing Time Days

50

Number Of Sites

1

Number Of Participants

66

Primary sponsor

Full Name

Fundacio De Recerca Clinic Barcelona-Institut D’investigacions Biomediques August Pi I Sunyer

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain