Clinical trial • Phase I • Neurology
[18F]ACI-19626 for Alzheimer's disease | Amyotrophic lateral sclerosis | Frontotemporal dementia | Limbic-predominant age-related TDP-43 encephalopathy (LATE)
Phase I trial of [18F]ACI-19626 for Alzheimer's disease | Amyotrophic lateral sclerosis | Frontotemporal dementia | Limbic-predominant age-related TDP-43…
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Alzheimer's disease | Amyotrophic lateral sclerosis | Frontotemporal dementia | Limbic-predominant age-related TDP-43 encephalopathy (LATE)
- Trial Stage
- Phase I
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 29-07-2024
- First CTIS Authorization Date
- 30-10-2024
Trial design
Phase I trial across 1 site in Netherlands.
- Target Sample Size
- 45
- Trial Duration For Participant
- 730
Recruitment
- Planned Sample Size
- 45
- Recruitment Window Months
- 24
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 45
Netherlands
- Earliest CTIS Part Ii Submission Date
- 27-09-2024
- Latest Decision Or Authorization Date
- 01-04-2025
- Processing Time Days
- 186
- Number Of Sites
- 1
- Number Of Participants
- 45
Sites
- Site Name
- Amsterdam UMC
- Department Name
- Radiology and Nuclear Medicine
- Contact Person Name
- Elsmarieke van de Giessen
- Contact Person Email
- e.m.vandegiessen@amsterdamumc.nl
Sponsor
Primary sponsor
- Full Name
- AC Immune SA
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- [18F]ACI-19626
- Active Substance
- [18F]ACI-19626
- Modality
- Radiopharmaceutical
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