Quantification tools for a novel tau PET marker in a rare neurological disease: 18F-PI-2620 in progressive supranuclear palsy

Overview

Sponsor-declared trial summary

Key facts

Sponsor

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

Participant type

Healthy volunteers, Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

9 Jan 2025 → ongoing

Decision date (initial)

2024-03-05

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

CIBER-BBN

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Diagnosis

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.

Secondary objectives 3

1. To develop a new algorithm for the quantification of PET images of the tau [18F]PI-2620 tracer that allows a better characterization of the images obtained
2. To correlate tau values quantified by PET-PI-2620 with demographic, clinical, and biomarker data of 4R-tau and NfL in cerebrospinal fluid (CSF)
3. To evaluate [18F]PI-2620 as a possible biomarker for PSP cases

Conditions and MedDRA coding

Progressive supranuclear palsy

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Patients of both sexes aged between 40 and 80 years.
2. The subject must be able to comply with the protocols and procedures necessary for the development of the clinical trial.
3. Consent of the subject or his/her legal representative to voluntarily participate in the study by signing the informed consent.
4. 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.
5. Magnetic resonance imaging (MRI) study of the brain to rule out any other type of relevant neurological pathology.
6. PSP population: Have a clinical diagnosis of soPSP or probable PSP according to current diagnostic criteria (Höglinger et al. 2017)
7. Parkinson population: Have a clinical diagnosis of soPSP or probable PSP according to current diagnostic criteria (Postuma et .a, 2015)
8. Control population: Absence of clinical history of neuropsychiatric diseases.

Exclusion criteria 12

1. 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).
2. 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.
3. Abuse of alcohol or other legal or illegal drugs (except nicotine).
4. Pregnancy.
5. Known allergy to PI-2620 or any of the other components of the radiopharmaceutical.
6. Any contraindication or impediment to the performance of the PET/CT study with PI-2620.
7. 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.
8. 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.
9. Subjects or their legal representatives who do not sign the informed consent.
10. 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.
11. Treatment with any other investigational medicinal products within 30 days prior to inclusion.
12. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. PI-2620 uptake determined by standard uptake value ratio (SUVR)

Secondary endpoints 3

1. SUVR of the base nuclei divided a reference region such as the brain stem.
2. SUVR of the cerebral cortex divided into a reference region such as the brain stem.
3. Association of PI-2620 uptake values with demographics, clinical variables and CSF biomarkers

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

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

Sponsor organisation

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

Address

Calle Rosellon 149-153

City

Barcelona

Postcode

08036

Country

Spain

Scientific contact point

Organisation

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

Contact name

Yaroslau Compta Hirnyj

Public contact point

Organisation

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

Contact name

Maria Eugenia Sáez

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications