Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
64
Countries
1
Sites
1
Corticobasal syndrome (CBS)
Key facts
- Sponsor
- ZRO Imaging AB
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Trial duration
- 6 Nov 2025 → ongoing
- Decision date (initial)
- 2025-11-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Corticobasal syndrome (CBS)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10036813 | Progressive supranuclear palsy | 100000004852 |
| 21.1 | PT | 10068968 | Frontotemporal dementia | 100000004852 |
| 20.1 | LLT | 10036223 | Positron emission tomography | 10022891 |
| 20.0 | PT | 10078208 | Corticobasal degeneration | 100000004852 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
ZRO Imaging AB
- Sponsor organisation
- ZRO Imaging AB
- Address
- Mardgatan 20, Alvsborg Alvsborg
- City
- Vastra Frolunda
- Postcode
- 426 71
- Country
- Sweden
Scientific contact point
- Organisation
- ZRO Imaging AB
- Contact name
- Dr. Alexis Moscoso
Public contact point
- Organisation
- ZRO Imaging AB
- Contact name
- Dr. Alexis Moscoso
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 64 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Complexo Hospitalario Universitario De Santiago
Medicina Nuclear, Calle Choupana Da S/n, 15706, Santiago De Compostela
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 | 2025-11-06 | 2025-11-11 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-14 | Spain | Acceptable 2025-11-03
|
2025-11-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-12-08 | Spain | Acceptable 2026-04-06
|
2026-04-13 |