Clinical trial • Phase I • Neurology
ALN-APP for Early-onset Alzheimer's disease
Phase I trial of ALN-APP for Early-onset Alzheimer's disease. 57 participants.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Early-onset Alzheimer's disease
- Trial Stage
- Phase I
- Drug Modality
- Oligonucleotide
Key dates
- Initial CTIS Submission Date
- 25-01-2024
- First CTIS Authorization Date
- 05-02-2024
Trial design
Phase I trial across 1 site in Netherlands.
- Target Sample Size
- 57
Eligibility
Recruits 57 Vulnerable population selected: patients with early-onset Alzheimer's disease (isVulnerablePopulationSelected = true); consent/assent handling not specified in source..
- Vulnerable Population
- Vulnerable population selected: patients with early-onset Alzheimer's disease (isVulnerablePopulationSelected = true); consent/assent handling not specified in source.
Recruitment
- Planned Sample Size
- 57
- Recruitment Window Months
- 78
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 57
Netherlands
- Earliest CTIS Part Ii Submission Date
- 01-02-2024
- Latest Decision Or Authorization Date
- 03-07-2025
- Processing Time Days
- 519
- Number Of Sites
- 1
- Number Of Participants
- 6
Sites
- Site Name
- Brain Research Center Amsterdam B.V.
- Department Name
- Neurology
- Principal Investigator Name
- Jort Vijverberg
- Principal Investigator Email
- j.vijverberg@brainresearchcenter.nl
- Contact Person Name
- Jort Vijverberg
- Contact Person Email
- j.vijverberg@brainresearchcenter.nl
Sponsor
Primary sponsor
- Full Name
- Alnylam Pharmaceuticals Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- ALN-APP
- Modality
- Oligonucleotide
- First In Human
- Yes
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