Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
187
Countries
4
Sites
10
Early Symptomatic Alzheimer’s Disease (eAD), (Mild Cognitive Impairment due to AD, or probable AD dementia)
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify, Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 17 Feb 2026 → ongoing
- Decision date (initial)
- 2025-12-02
- 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
Early Symptomatic Alzheimer’s Disease (eAD), (Mild Cognitive Impairment due to AD, or probable AD dementia)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Locations
4 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruiting | 12 | 1 |
| Poland | Authorised, recruitment pending | 31 | 3 |
| Spain | Authorised, recruiting | 50 | 4 |
| Sweden | Ongoing, recruiting | 24 | 2 |
| Rest of world
Canada, United Kingdom
|
— | 70 | — |
Investigational sites
Brain Research Center Amsterdam B.V.
Neurology, Cronenburg 2, 1081 GN, Amsterdam
Krakowska Akademia Neurologii Sp. z o.o.
N/A, Ul. Arianska 7/3, 31-505, Cracow
Revit Sp. z o.o.
Podlaskie Centrum Psychogeriatrii, Ul. Swobodna 38, 15-756, Bialystok
Centrum Medyczne Neuroprotect
N/A, Ul. Klaudyny 16c, 1 Piętro, Warsaw
Hospital De La Santa Creu I Sant Pau
Neurology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitari General De Catalunya
Neurology, Carrer Pedro I Pons 1, 08195, Sant Cugat Del Valles
Fundacio Ace Institut Catala De Neurociencies Aplicades
Neurology, Gran Via De Carles III 85 Bis, 08028, Barcelona
Hospital Universitario Reina Sofia
Neurology, Avenida Menendez Pidal S/n, 14004, Cordoba
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 |
|---|---|---|---|---|---|
| Netherlands | 2026-02-17 | ||||
| Spain | 2026-05-07 | ||||
| Sweden | 2026-03-25 | 2026-04-07 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-07 | Spain | Acceptable with conditions 2025-12-01
|
2025-12-02 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-27 | Spain | Acceptable with conditions 2025-12-01
|
2026-01-27 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-02-11 | Spain | Acceptable with conditions 2025-12-01
|
2026-02-11 |