Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
72
Countries
1
Sites
1
Alzheimer
Key facts
- Sponsor
- Remynd
- 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
- 20 Mar 2025 → 15 Dec 2025
- Decision date (initial)
- 2025-03-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Alzheimer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Remynd
- Sponsor organisation
- Remynd
- Address
- Gaston Geenslaan 1
- City
- Leuven
- Postcode
- 3001
- Country
- Belgium
Scientific contact point
- Organisation
- Remynd
- Contact name
- -
Public contact point
- Organisation
- Remynd
- Contact name
- -
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 72 | 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 | 2025-03-20 | 2025-03-20 | 2025-12-15 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-31 | Belgium | Acceptable 2025-03-07
|
2025-03-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-07 | Belgium | Acceptable 2025-11-10
|
2025-11-12 |