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

StatusRecruiting
PhasePhase 2
Started2026-08-17
View on ClinicalTrials.gov ↗

Amendment history

2026-09-03
Study Status, Contacts/Locations v3
Start dateestimated 2026-08-31→confirmed 2026-08-17
Study sites2→3
2026-08-11
Study Status, Contacts/Locations v2
Recruitment opened
Start date2026-07-31→2026-08-31
Study sitesdetails revised at 2 of 2 sites
2026-07-14
Study Status v1
Start date2026-07-01→2026-07-31
2026-06-04
Original filing
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.
Trial Details
NCT Number NCT07636811
Lead Sponsor Alnylam Pharmaceuticals
Conditions Down Syndrome-Associated Alzheimer's Disease (DS-AD)
Enrollment 58 participants
Start Date 2026-08-17
Primary Completion 2030-05-18 (estimated)
Study Completion 2031-07-23 (estimated)
Updated on ClinicalTrials.gov 2026-09-04