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NCT07636811

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

Recruiting
PHASE2Ages 40–55InterventionalTreatment
Alnylam Pharmaceuticals
~58 participants
Updated 2026-09-04 on ClinicalTrials.gov
What's tested:MivelsiranPlacebo

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Double-Blind Period: Change from baseline in brain amyloid burden measured in centiloids (CLs)
Measured over Up to 24 months

Conditions

Down Syndrome-Associated Alzheimer's Disease (DS-AD)

Explore related trials

Down Syndrome-Associated Alzheimer's DiseaseAmyloid

NCT07636811

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Clinical Study Site

    Maitland, Floridano site contact published

    Recruiting

  • Clinical Study Site

    Naples, Floridano site contact published

    Recruiting

  • Clinical Trial Site

    Seville, Spainno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Medical Director · STUDY_DIRECTOR · Alnylam Pharmaceuticals

Who to contact

Alnylam Clinical Trial Information Line
[email protected]
1-877-ALNYLAM
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Clinical diagnosis of Down-Syndrome (DS) associated with trisomy 21
Positive amyloid PET scan
Cognitively stable in the opinion of the investigator
Seizures must be well controlled with no occurrence of seizures in the 6 months prior to screening

Exclusion

Has severe intellectual disability (ID)
Has a history of DS regression disorder
Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2×upper limit of normal (ULN) at Screening
Has estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73m\^2 at Screening
Has recently received an investigational agent
Has had treatment with amyloid-targeting antibody
Comorbidities such as obstructive sleep apnea and hypothyroidism that are not well controlled

What this trial measures

  • Double-Blind Period: Change from baseline in brain amyloid burden measured in centiloids (CLs)Up to 24 months