Clinical trial • Phase I • Neurology
ALN-5288 for Alzheimer's disease
Phase I trial of ALN-5288 for Alzheimer's disease. Randomised, open-label, placebo (dose/schedule not specified)-controlled. 35 participants.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Alzheimer's disease
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 02-10-2025
- First CTIS Authorization Date
- 10-02-2026
Trial design
Randomised, open-label, placebo (dose/schedule not specified)-controlled Phase I trial in Spain, Netherlands.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Placebo (dose/schedule not specified)
- Target Sample Size
- 35
- Trial Duration For Participant
- 1401
Recruitment
- Planned Sample Size
- 35
- Recruitment Window Months
- 46
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 15
Spain
- Earliest CTIS Part Ii Submission Date
- 02-02-2026
- Latest Decision Or Authorization Date
- 12-02-2026
- Processing Time Days
- 10
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Hospital Universitari General De Catalunya
- Department Name
- Neurology
- Principal Investigator Name
- Ernest Balaguer Martínez
- Principal Investigator Email
- ebalaguer@quironsalud.es
- Contact Person Name
- Ernest Balaguer Martínez
- Contact Person Email
- ebalaguer@quironsalud.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Neurology
- Principal Investigator Name
- Raquel Sanchez del Valle-Diaz
- Principal Investigator Email
- rsanchez@clinic.cat
- Contact Person Name
- Raquel Sanchez del Valle-Diaz
- Contact Person Email
- rsanchez@clinic.cat
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Neurology
- Principal Investigator Name
- Jordi Matias Guiu Antem
- Principal Investigator Email
- jordi.matiasguiu@salud.madrid.org
- Contact Person Name
- Jordi Matias Guiu Antem
- Contact Person Email
- jordi.matiasguiu@salud.madrid.org
Netherlands
- Earliest CTIS Part Ii Submission Date
- 30-01-2026
- Latest Decision Or Authorization Date
- 23-02-2026
- Processing Time Days
- 24
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Brain Research Center Den Bosch B.V.
- Department Name
- Neurology
- Principal Investigator Name
- Everard (Jort) Vijverberg
- Principal Investigator Email
- j.vijverberg@brainresearchcenter.nl
- Contact Person Name
- Everard (Jort) Vijverberg
- Contact Person Email
- j.vijverberg@brainresearchcenter.nl
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Neurology
- Principal Investigator Name
- Everard (Jort) Vijverberg
- Principal Investigator Email
- j.vijverberg@brainresearchcenter.nl
- Contact Person Name
- Everard (Jort) Vijverberg
- Contact Person Email
- j.vijverberg@brainresearchcenter.nl
- Site Name
- Brain Research Center Amsterdam B.V.
- Department Name
- Neurology
- Principal Investigator Name
- Everard (Jort) Vijverberg
- Principal Investigator Email
- j.vijverberg@brainresearchcenter.nl
- Contact Person Name
- Everard (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-5288
- Routes Of Administration
- Intrathecal
- Route
- Intrathecal
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