Clinical Trial

A Study to Evaluate the Safety and Tolerability of ALN-APP in Patients With EOAD

Recruiting Phase 1
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Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of a single dose and multiple doses of ALN-APP administered by intrathecal (IT) injection in adult patients with early-onset Alzheimer's Disease (EOAD). Maximum treatment duration for Part A: single dose. Maximum treatment duration for Part B: 12 months.
Protocol Amendment History 47 amendments
This ClinicalTrials.gov record has been amended 47 times since 2022-01-30; most recent amendment 2026-07-14.
Status change: Not Yet Recruiting → Recruiting 2022-03-14
Trial Details
NCT Number NCT05231785
Lead Sponsor Alnylam Pharmaceuticals
Conditions Early-Onset Alzheimer Disease
Enrollment 60 participants
Start Date 2022-02-04
Primary Completion 2029-04-20 (estimated)
Study Completion 2029-04-20 (estimated)
Updated on ClinicalTrials.gov 2026-08-12