Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
90
Countries
1
Sites
1
Alzheimer's Disease (Healthy Participants)
Key facts
- Sponsor
- Janssen Cilag International
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 17 Oct 2022 → 21 May 2025
- Decision date (initial)
- 2024-06-19
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513656-15-00
- EudraCT number
- 2021-006228-42
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Alzheimer's Disease (Healthy Participants)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Janssen Cilag International
- Sponsor organisation
- Janssen Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen Cilag International
- Contact name
- CTIS Point of Contact
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 90 | 1 |
| 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 |
|---|---|---|---|---|---|
| Belgium | 2022-10-17 | 2025-05-21 | 2022-10-19 | 2025-02-14 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-11 | Belgium | Acceptable 2024-06-19
|
2024-06-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-29 | Belgium | Acceptable 2024-08-27
|
2024-08-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-26 | Belgium | Acceptable | 2024-10-18 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-01-31 | Belgium | Acceptable 2025-03-10
|
2025-03-10 |