drugset / Trial / NCT05231785

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

NCT05231785 ↗

Phase 1 Recruiting 60 enrolled Alnylam Pharmaceuticals
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2022-02-04
Primary completion
2029-04-20
Completion
2029-04-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Mivelsiran Unknown — Intrathecal

Indications