Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
150
Countries
1
Sites
1
Cognitive Disorders including Alzheimer's Disease, Frontotemporal dementia, Lewy Body Disease and psychiatric disorders.
Key facts
- Sponsor
- UZ Leuven
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Trial duration
- 12 Jul 2024 → 8 Jul 2025
- Decision date (initial)
- 2024-06-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-514577-22-00
- ClinicalTrials.gov
- NCT05384353
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Cognitive Disorders including Alzheimer's Disease, Frontotemporal dementia, Lewy Body Disease and psychiatric disorders.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
UZ Leuven
- Sponsor organisation
- UZ Leuven
- Address
- Herestraat 49
- City
- Leuven
- Postcode
- 3000
- Country
- Belgium
Scientific contact point
- Organisation
- UZ Leuven
- Contact name
- Koen Van Laere
Public contact point
- Organisation
- UZ Leuven
- Contact name
- Koen Van Laere
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 150 | 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 |
|---|---|---|---|---|---|
| Belgium | 2024-07-12 | 2024-07-12 | 2025-05-28 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-12 | Belgium | Acceptable 2024-06-19
|
2024-06-19 |