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

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
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
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

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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