Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
37
Countries
4
Sites
10
Alzheimer’s Disease
Key facts
- Sponsor
- Novartis Pharma AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 23 Feb 2023 → ongoing
- Decision date (initial)
- 2024-08-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-514004-14-00
- EudraCT number
- 2022-000921-26
- ClinicalTrials.gov
- NCT05469360
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
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel
- Postcode
- 4056
- Country
- Switzerland
Scientific contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Public contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Locations
4 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ended | 3 | 2 |
| France | Ongoing, recruitment ended | 13 | 3 |
| Spain | Ongoing, recruitment ended | 15 | 3 |
| Sweden | Ended | 6 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Clinical Research Services Turku CRST Oy
1101 : Clinical Research Unit (Phase I), Joukahaisenkatu 2 B, 20520, Turku
University Of Eastern Finland
1102 : Institute of Clinical Medicine, Brain Research Unit, P. O. Box 1627, 70211, Kuopio
Assistance Publique Hopitaux De Paris
3001 : département des maladies du système nerveux, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Centre Hospitalier Universitaire De Lille
3002 : Centre Mémoire de Ressources et de Recherche, Rue Emile Laine, 59037, Lille Cedex
Centre Hospitalier Universitaire De Toulouse
3000 : Département de Neurologie, 1 Place Du Docteur Joseph Baylac, 31300, Toulouse
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 |
|---|---|---|---|---|---|
| Finland | 2023-10-03 | 2025-08-05 | 2023-10-03 | 2023-12-12 | |
| France | 2023-06-21 | 2023-06-21 | 2026-03-12 | ||
| Spain | 2023-09-05 | 2023-09-05 | 2026-02-03 | ||
| Sweden | 2023-02-23 | 2025-07-31 | 2023-02-23 | 2023-11-29 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-12 | Sweden | Acceptable with conditions 2024-08-02
|
2024-08-02 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-04 | Sweden | Acceptable with conditions 2024-08-02
|
2024-12-04 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-11 | Sweden | Acceptable 2025-05-08
|
2025-05-09 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-05-27 | Acceptable 2025-05-08
|
2025-05-27 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-06 | Sweden | Acceptable 2025-08-25
|
2025-08-27 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-15 | Acceptable 2026-01-07
|
2026-01-09 |