drugset / Trial / NCT07636811

A Study to Evaluate Mivelsiran in Adult Participants With Early-Stage Down Syndrome-Associated Alzheimer's Disease (DS-AD)

NCT07636811 ↗

Phase 2 Not yet recruiting 58 enrolled Alnylam Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of the study is to evaluate the effect of mivelsiran in adult participants with early-stage DS-AD and to characterize the safety, tolerability, and pharmacodynamics (PD) of mivelsiran. The study will be conducted over 2 periods: a 24-month double-blind period and an optional 12-month open-label treatment extension (OLE) period. The estimated duration of study participation, inclusive of screening, treatment, and additional safety follow-up, is up to 39 months.

Timeline

Start
2026-07-31
Primary completion
2030-05-18
Completion
2031-07-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Mivelsiran Unknown — Intrathecal

Indications