Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
5
Countries
1
Sites
1
Alzheimer's disease
Key facts
- Sponsor
- Hopital Fondation Adolphe De Rothschild
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 16 Apr 2025 → ongoing
- Decision date (initial)
- 2024-07-01
- 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
Hopital Fondation Adolphe De Rothschild
- Sponsor organisation
- Hopital Fondation Adolphe De Rothschild
- Address
- 25 Rue Manin
- City
- Paris
- Postcode
- 75019
- Country
- France
Scientific contact point
- Organisation
- Hopital Fondation Adolphe De Rothschild
- Contact name
- Amélie Yavchitz
Public contact point
- Organisation
- Hopital Fondation Adolphe De Rothschild
- Contact name
- Amélie Yavchitz
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 5 | 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 |
|---|---|---|---|---|---|
| France | 2025-04-16 | 2026-03-17 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-11 | France | Acceptable 2024-07-01
|
2024-07-01 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-29 | France | Acceptable 2025-03-28
|
2025-03-28 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-20 | France | Acceptable 2025-08-01
|
2025-08-01 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-04-09 | France | Acceptable 2026-05-11
|
2026-05-21 |