Quantification Tools for a Novel Tau PET Marker in a Rare Neurological Disease: 18F-PI-2620 in Progressive Supranuclear Palsy

NCT07105384 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 2023-508718-40-00
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial is to explore the potential of novel 2nd generation tau PET radiotracers as biomarkers in cases suggestive of progressive supranuclear palsy (PSP), an atypical form of parkinsonism.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Differences in uptake levels of PET-PI-2620, a brain tau radiotracer, in participants with a diagnosis suggestive of PSP, probable PSP, Parkinson's and controls without neurological pathology.

  The aim of this clinical trial is to explore the potential of novel 2nd generation tau PET radiotracers as biomarkers in cases suggestive of progressive supranuclear palsy (PSP), an atypical form of parkinsonism( Molecular imaging)

  Day Zero Visit 1

Secondary Outcomes (16)

• Standard optic value ratio(SUVR) from basic core

  Day Zero Visit 1

• Standard optic value ratio(SUVR) from cerebral cortex

  Day Zero Visit 1

• PI-2620 Captation in compare to demographics as age

  Day Zero Visit 1

• PI-2620 Captation in compare to demographics as gender

  Day Zero Visit 1

• PI-2620 Captation in compare to demographics as reference Hospital

  Day Zero Visit 1

Study Arms (4)

Patients suggestive of progressive supranuclear paralysis

ACTIVE COMPARATOR

Patients will receive the radiotracer

Combination Product: Radiotracer

Patients with probable progressive supranuclear palsy

ACTIVE COMPARATOR

Patients will receive the radiotracer

Combination Product: Radiotracer

Control Arm. No pathologies control arm

ACTIVE COMPARATOR

Patients will receive the radiotracer

Combination Product: Radiotracer

Control arm. Patients with parkinson

ACTIVE COMPARATOR

Patients will receive the radiotracer

Combination Product: Radiotracer

Interventions

Radiotracer COMBINATION_PRODUCT

Patients will receive a brain tau radiotracer

Control Arm. No pathologies control arm; Control arm. Patients with parkinson; Patients suggestive of progressive supranuclear paralysis; Patients with probable progressive supranuclear palsy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For all patients:
• Patients of both sexes between 40 and 80 years of age.
• The subject must be able to comply with the protocols and procedures necessary for the development of the clinical trial.
• Conformity of the subject or his/her legal representative to voluntarily participate in the study by signing the informed consent form.
• For PSP patients:
• Have a clinical diagnosis of probable soPSP or PSP according to current diagnostic criteria (Höglinger et al. current diagnostic criteria (Höglinger et al. 2017).
• Magnetic resonance imaging (MRI) study that rules out any other relevant neurological pathology. relevant neurological pathology.
• For Parkinson patients:
• To have a clinical diagnosis of Parkinson's disease according to established criteria (Postuma et al. 2015).
• Magnetic resonance imaging (MRI) study that rules out any other relevant neurological pathology.
• For control patients:
• \- Absence of clinical history of neuropsychiatric disease.

You may not qualify if:

• For all patients:
• 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 traumatic brain injury, history of epilepsy or seizures history of major or recurrent traumatic brain injury, history of epilepsy or seizures(except febrile seizures in childhood without current antiepileptic medication).
• Presence of terminal illness or illnesses that may put the patient's health at risk by participating in the the patient's health by participating in the study or influencing the results of the study or the patient's or on 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.
• with PI-2620.
• Subjects who are not capable of understanding and/or complying with the guidelines necessary for the performance of the test (e.g.: interrogation, physical examination, attending the lumbar puncture, attending the visits, etc.) and who do not have responsible accompanying persons who understand and are committed to complying with these guidelines.
• Subjects who do not cooperate or are not capable of complying with the required procedures required for this clinical trial, such as (but not limited to): social disorders that anticipate an evident lack of collaboration, psychopathy, drug or alcohol abuse.
• Subjects or their legal representatives who do not sign the informed consent.
• Legal incapacity and/or circumstances that prevent the subject or his/her legal representatives from understanding the nature, objectives, potential and possible consequences of the trial.
• For PSP patients:
• \- 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.

Sponsors & Collaborators

• Fundacion Clinic per a la Recerca Biomédica: lead

Study Sites (1)

Laura Burunat

Barcelona, Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: August 5, 2025
• Study Start: February 4, 2025
• Primary Completion (Estimated): June 20, 2028
• Study Completion (Estimated): December 20, 2028
• Last Updated: August 5, 2025

Record last verified: 2025-03

Locations

ES (1)