Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
51
Countries
1
Sites
2
Progressive supranuclear palsy
To compare the brain deposit of tau 4R protein by means of the PET-Tau imaging study using the 18F-PI2620 radiotracer in patients with PSP compared to controls.
Key facts
- Sponsor
- University Clinic Of Navarra
- 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
- 13 Nov 2023 → ongoing
- Decision date (initial)
- 2023-08-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Proyectos de investigacion en salud (AES 2020). Instituto de Salud Carlos III.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
To compare the brain deposit of tau 4R protein by means of the PET-Tau imaging study using the 18F-PI2620 radiotracer in patients with PSP compared to controls.
Secondary objectives 4
- Evaluate the localization and load of tau in controls (PD patients and healthy subjects).
- Evaluate the localization and load of tau in different subtypes of PSP (SR, non-SR).
- Compare the topographic distribution of PET-Tau with the pattern of glucose metabolism by PET-FDG at the individual and group level according to PSP subtypes.
- To explore the correlation between PET-Tau (18F-PI2620) and PET-FDG (18F-FDG) uptake with the severity of motor (rigidity, bradykinesia, falls, dysarthria, etc.) and non-motor (depression, apathy, cognitive impairment) symptoms.
Conditions and MedDRA coding
Progressive supranuclear palsy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10036813 | Progressive supranuclear palsy | 100000004852 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Subjects from one of the following two groups: a) Patients aged between 40 and 79 years, with a clinical diagnosis of different variants of PSP. Clinical diagnosis will be based on the MDS-PSP criteria for PSP subtypes (Höglinger et al., 2017). In addition, we will apply the recently proposed Multiple Allocations eXtinction (MAX) rules to approach ambiguous multiple allocations (Grimm et al., 2019). b) Control group: b.1.. Patients aged 40 to 79 years, with a clinical diagnosis of PD according to the UK Parkinson's Disease Society Brain Bank Diagnostic Criteria (Hughes et al., 1992) and normal cognitive status (MoCA>24). b.2.. Healthy subjects (male or female) aged 40 to 79 years, with normal neurological examination and normal cognitive status (MoCA>24).
- The subject, or their representative, has given their consent to participate in the study.
- The subject must, in the opinion of the investigator, be able to meet all the requirements of the clinical trial.
Exclusion criteria 3
- Patients with evidence of relevant structural brain abnormalities or significant leukoencephalopathy on magnetic resonance imaging (MRI) (Fazekas score ≥3 or a score of ≥3 on the age-related white matter changes Rating Scale) (Wahlund et al., 2001).
- Patients with PD with cognitive impairment (MoCA<24).
- Pregnant, breastfeeding or childbearing women who are not going to use contraception.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Brain deposit of tau 4R protein by means of the PET-Tau imaging study using the 18F-PI2620 radiotracer
Secondary endpoints 2
- Pattern of glucose metabolism by PET-FDG
- Motor (rigidity, bradykinesia, falls, dysarthria, etc.) and non-motor (depression, apathy, cognitive impairment) symptoms
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD8361304 · Product
- Active substance
- Izaflortaucipir (18F)
- Substance synonyms
- [18F]PI-2620, 2-(2-(18F)fluoropyridin-4-yl)-9H-pyrrolo[2,3-b:4,5-c']dipyridine, [18F]MNI-960
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS SLOW BOLUS INJECTION
- Max daily dose
- 5 mCi millicurie(s)
- Max total dose
- 5 mCi millicurie(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- LIFE MOLECULAR IMAGING GMBH
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University Clinic Of Navarra
- Sponsor organisation
- University Clinic Of Navarra
- Address
- Pio XII Etorbidea 36
- City
- Pamplona
- Postcode
- 31008
- Country
- Spain
Scientific contact point
- Organisation
- University Clinic Of Navarra
- Contact name
- UCEC
Public contact point
- Organisation
- University Clinic Of Navarra
- Contact name
- UCEC
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruitment ended | 51 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2023-11-13 | 2023-12-11 | 2025-06-30 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-16 | Spain | Acceptable 2023-08-07
|
2023-08-07 |