Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
900
Countries
2
Sites
5
Alzheimer’s Disease
Key facts
- Sponsor
- Othair Prothena Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 27 Mar 2024 → 16 Jan 2026
- Decision date (initial)
- 2024-01-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
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
Othair Prothena Limited
- Sponsor organisation
- Othair Prothena Limited
- Address
- Block C, 77 Sir John Rogersons Quay, Grand Canal Docklands 77 Sir John Rogersons Quay Grand Canal Docklands
- City
- Dublin 2
- Postcode
- D02 VK60
- Country
- Ireland
Scientific contact point
- Organisation
- Othair Prothena Limited
- Contact name
- Regulatory Affairs
Public contact point
- Organisation
- Othair Prothena Limited
- Contact name
- Regulatory Affairs
Locations
2 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ended | 20 | 3 |
| Spain | Ended | 20 | 2 |
| Rest of world
United States
|
— | 860 | — |
Investigational sites
Promente Sp. z o.o.
Promente -Centrum Neurologii i Psychogeriatrii w Bydgoszczy-this is medical entity where is trial, Ul. Teofila Lenartowicza 33/35, 85-133, Bydgoszcz
Neurologia Śląska Centrum Medyczne
Neurologia Śląska Centrum Medyczne, ul. Małachowskiego 51, 40-689, Katowice
Centrum Medyczne Neuromed Sp. z o.o.
Centrum Medyczne Neuromed Sp z o.o, Ul. Jana Biziela 14, 85-163, Bydgoszcz
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 |
|---|---|---|---|---|---|
| Poland | 2024-04-12 | 2024-04-15 | 2024-11-20 | ||
| Spain | 2024-03-27 | 2024-04-15 | 2024-12-11 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-15 | Poland | Acceptable 2024-01-22
|
2024-01-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-01-30 | Acceptable | 2024-02-28 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-02-01 | Poland | Acceptable | 2024-03-29 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-07-05 | Poland | Acceptable 2024-08-19
|
2024-08-20 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-06-04 | Poland | Acceptable 2025-07-21
|
2025-07-23 |