Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
32
Countries
1
Sites
2
Alzheimer's Disease
Key facts
- Sponsor
- Therini Bio Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 8 May 2025 → ongoing
- Decision date (initial)
- 2025-04-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519899-72-00
- ClinicalTrials.gov
- NCT06814730
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Alzheimer's Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10001896 | Alzheimer's disease | 10029205 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Therini Bio Inc.
- Sponsor organisation
- Therini Bio Inc.
- Address
- 2108 N Street Suite 4963
- City
- Sacramento
- Postcode
- 95816-5712
- Country
- United States
Scientific contact point
- Organisation
- Therini Bio Inc.
- Contact name
- Nuno Mendonca, MD
Public contact point
- Organisation
- Therini Bio Inc.
- Contact name
- Nuno Mendonca, MD
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruitment ended | 12 | 2 |
| Rest of world
United Kingdom
|
— | 20 | — |
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 |
|---|---|---|---|---|---|
| Netherlands | 2025-05-08 | 2025-06-23 | 2026-05-20 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-03 | Netherlands | Acceptable with conditions 2025-04-07
|
2025-04-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-01 | Netherlands | Acceptable 2025-05-20
|
2025-05-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-07 | Netherlands | Acceptable 2025-08-11
|
2025-08-11 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-08-13 | Netherlands | Acceptable 2025-08-11
|
2025-08-13 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-10-29 | Netherlands | Acceptable 2025-11-25
|
2025-11-28 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-01-23 | Netherlands | Acceptable 2026-02-20
|
2026-02-20 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-04-02 | Netherlands | Acceptable 2026-02-20
|
2026-04-02 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-05-27 | Netherlands | Acceptable 2026-02-20
|
2026-05-27 |