Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
45
Countries
3
Sites
4
Early Alzheimer's disease
Key facts
- Sponsor
- Janssen Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 25 Feb 2025 → 9 Jan 2026
- Decision date (initial)
- 2024-12-16
- 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
Early Alzheimer's disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10012271 | Dementia Alzheimer's type | 100000004852 |
| 20.0 | PT | 10074616 | Prodromal Alzheimer's disease | 100000004852 |
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
3 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 10 | 2 |
| Netherlands | Ended | 5 | 1 |
| Spain | Ended | 5 | 1 |
| Rest of world
Canada, United States
|
— | 25 | — |
Investigational sites
Pellegrin Hospital
Neurology, Place Amelie Raba Leon, 33000, Bordeaux
Centre Hospitalier Universitaire De Lille
Neurology, Avenue Du Professeur Emile Laine, 59037, Lille Cedex
Brain Research Center Den Bosch B.V.
Brain Research Center Den Bosch / Jeroen Bosch Ziekenhuis, Statenlaan 37, 5223 LA, 's-Hertogenbosch
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 | 2025-03-25 | 2025-03-25 | 2026-01-08 | ||
| Netherlands | 2025-02-25 | 2025-02-25 | 2026-01-08 | ||
| Spain | 2025-11-24 | 2025-11-24 | 2026-01-08 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-30 | Spain | Acceptable 2024-12-16
|
2024-12-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-16 | Spain | Acceptable 2025-05-22
|
2025-05-22 |