NCT07636811
A Study to Evaluate Mivelsiran in Adult Participants With Early-Stage Down Syndrome-Associated Alzheimer's Disease (DS-AD)
Not Yet Recruiting
PHASE2Ages 40–55InterventionalTreatmentAlnylam Pharmaceuticals
~58 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:MivelsiranPlacebo
At a glance
Recruiting sites
0 of 2 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
Where it's being run
2 sites across 1 statesFlorida2
Study leadership
- Medical Director · STUDY_DIRECTOR · Alnylam Pharmaceuticals
Who to contact
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Do you actually qualify for this trial?
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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