Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
45
Countries
1
Sites
1
Alzheimer's Disease
Key facts
- Sponsor
- AC Immune SA
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 20 Nov 2024 → ongoing
- Decision date (initial)
- 2024-10-30
- 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 | HLT | 10012268 | Dementia (excl Alzheimer's type) | 10029205 |
| 20.0 | LLT | 10001896 | Alzheimer's disease | 10029205 |
| 21.1 | PT | 10002026 | Amyotrophic lateral sclerosis | 100000004852 |
| 21.1 | PT | 10068968 | Frontotemporal dementia | 100000004852 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AC Immune SA
- Sponsor organisation
- AC Immune SA
- Address
- Innovation Park
- City
- Lausanne
- Postcode
- 1015
- Country
- Switzerland
Scientific contact point
- Organisation
- AC Immune SA
- Contact name
- Clinical Trial Information
Public contact point
- Organisation
- AC Immune SA
- Contact name
- Clinical Trial Information
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 45 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Amsterdam UMC
Radiology and Nuclear Medicine, De Boelelaan 1117, 1081 HV, Amsterdam
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 | 2024-11-20 | 2025-01-21 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-29 | Netherlands | Acceptable 2024-10-30
|
2024-10-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-11 | Netherlands | Acceptable | 2025-04-01 |