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A Phase 1, Randomized, Placebo-controlled Study With a Double Blind Period With Open-label Extension Period to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ALN-5288 in Adult Patients With Alzheimer's Disease
The purpose of this study is to: * Evaluate the safety and tolerability of intrathecal (IT) ALN-5288 in patients with Alzheimer's Disease (AD) * Evaluate the pharmacodynamic (PD) and pharmacokinetic (PK) effects of ALN-5288 after dose administration
Age
40 - 80 years
Sex
ALL
Healthy Volunteers
No
Clinical Trial Site
Montreal, Canada
Clinical Trial Site
Ottawa, Canada
Clinical Trial Site
Toronto, Canada
Clinical Trial Site
Toronto, Canada
Clinical Trial Site
Glasgow, United Kingdom
Clinical Trial Site
London, United Kingdom
Start Date
October 15, 2025
Primary Completion Date
March 6, 2030
Completion Date
March 6, 2030
Last Updated
February 20, 2026
50
ESTIMATED participants
ALN-5288
DRUG
Placebo
DRUG
Lead Sponsor
Alnylam Pharmaceuticals
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07033494