Clinical trial • Phase III • Neurology
trontinemab for Alzheimer's disease
Phase III trial of trontinemab for Alzheimer's disease. 20 participants.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Alzheimer's disease
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 07-08-2024
- First CTIS Authorization Date
- 15-10-2024
Trial design
Phase III trial in Netherlands.
- Target Sample Size
- 20
Eligibility
Recruits 20 Vulnerable population selected in the protocol metadata; no further details on consent or assent handling are provided in the available record..
- Vulnerable Population
- Vulnerable population selected in the protocol metadata; no further details on consent or assent handling are provided in the available record.
Recruitment
- Planned Sample Size
- 20
- Recruitment Window Months
- 5
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 20
Netherlands
- Earliest CTIS Part Ii Submission Date
- 11-10-2024
- Latest Decision Or Authorization Date
- 15-08-2025
- Processing Time Days
- 308
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- Stichting Amsterdam UMC
- Department Name
- Department of Radiology and Nuclear Medicine
- Contact Person Name
- Elsmarieke van de Giessen
- Contact Person Email
- ctis@amsterdamumc.nl
- Number Of Participants
- 20
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- Trontinemab
- Active Substance
- trontinemab
- Modality
- Monoclonal antibody
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