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ALN-APP

Phase 2

Cerebral Amyloid Angiopathy | Small molecule | Other |Alnylam Pharmaceuticals, Inc.|Last Updated: May 14, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06393712A Phase 2 Trial of ALN-APP in Patients With Cerebral Amyloid AngiopathyPHASE2 RECRUITING 200May 17, 2024Dec 14, 2029May 14, 202657 United States, Australia +4
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Study Endpoints
Primary Endpoints
Double-blind Treatment Period: Annualized Rate of New Lobar Cerebral Microbleeds (CMBs) Assessed on Magnetic Resonance Imaging (MRI) of Brain in Patients with Sporadic Cerebral Amyloid Angiopathy (sCAA)
Up to 24 months
Secondary Endpoints
Double-blind Treatment Period: Global Rank Based on Severity, Count, Symptom Burden, and Timing of New Clinical Hemorrhagic Events and Hemorrhagic Lesions Assessed on MRI of Brain
Up to 24 months
Double-blind Treatment Period: Change from Baseline Over Time in Cerebrovascular Vasoreactivity Measured by Blood Oxygenation Level Dependent (BOLD) Parameters with Visual-evoked Functional MRI
Up to 24 months
Double-blind Treatment Period: Incidence of New Cerebral Hemorrhagic Lesions and White Matter Hyperintensities Assessed on MRI of Brain
Up to 24 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ALN-APPEXPERIMENTALParticipants will be administered multiple doses of ALN-APP during the double-blind treatment period and optional open-label extension period.
Placebo/ALN-APPPLACEBO_COMPARATORParticipants will be administered multiple doses of placebo during the double-blind treatment period. Participants who continue into the optional open-label extension period will be administered multiple doses of ALN-APP.
Interventions
NameTypeDescription
PlaceboDRUGPlacebo will be administered intrathecally
ALN-APPDRUGALN-APP will be administered intrathecally
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Eligibility Criteria
Age Range30 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites57

Inclusion Criteria (sporadic CAA patients): * Is 50 years or older * Has probable CAA per the Boston Criteria Version 2.0 Inclusion Criteria (Dutch-type CAA patients): * Is 30 years or older * Has known E693Q amyloid precursor protein (APP) gene mutation for Dutch-type CAA Exclusion Criteria: *...

Countries:United StatesAustraliaCanadaNetherlandsSwitzerlandUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06393712primaryCompletionDate: changed
LOWMay 24, 2026NCT06393712studyFirstPostDate: changed