EMERGE (Study 302)

E133123

EMERGE (Study 302) is a pivotal Phase 3 clinical trial designed to evaluate the efficacy and safety of the Alzheimer’s disease drug aducanumab (Aduhelm) in patients with early-stage Alzheimer’s.

All labels observed (1)

Label Occurrences
EMERGE (Study 302) canonical 2

How this entity was disambiguated

Statements (37)

Predicate Object
instanceOf Phase 3 clinical trial ⓘ
clinical trial ⓘ
pivotal trial ⓘ
biomarkerAssessment amyloid plaque levels in the brain ⓘ
coDeveloperCompany Eisai ⓘ
controlType placebo ⓘ
designFeature double-blind ⓘ
placebo-controlled ⓘ
randomized ⓘ
diseaseCategory dementia ⓘ
neurocognitive disorder ⓘ
drugBrandName Aduhelm ⓘ
drugGenericName aducanumab ⓘ
linked to: Aduhelm
drugTarget amyloid beta ⓘ
drugType monoclonal antibody ⓘ
evaluatesDrug Aduhelm ⓘ
aducanumab ⓘ
linked to: Aduhelm
geographicScope multinational ⓘ
hasPhase Phase 3 ⓘ
indication Alzheimer’s disease ⓘ
linked to: Alzheimer's disease
intervention intravenous aducanumab ⓘ
mechanismOfAction anti-amyloid beta monoclonal antibody ⓘ
patientPopulation patients with early Alzheimer’s disease ⓘ
patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia ⓘ
primaryEndpointDomain cognition and function in Alzheimer’s disease ⓘ
primaryEndpointType clinical efficacy ⓘ
primaryObjective evaluate efficacy of aducanumab in early-stage Alzheimer’s disease ⓘ
regulatoryRole pivotal study supporting FDA review of aducanumab ⓘ
relatedTrial ENGAGE (Study 301) ⓘ
safetyAssessment adverse events related to aducanumab ⓘ
amyloid-related imaging abnormalities (ARIA) ⓘ
secondaryObjective evaluate safety of aducanumab in early-stage Alzheimer’s disease ⓘ
sponsor Biogen ⓘ
sponsorCountry United States ⓘ
targetsDiseaseStage early-stage Alzheimer’s disease ⓘ
therapeuticArea neurodegenerative diseases ⓘ
neurology ⓘ

How these facts were elicited

Referenced by (2)

Full triples — surface form annotated when it differs from this entity's canonical label.

Aduhelm → clinicalTrial → EMERGE (Study 302) ⓘ
ENGAGE (Study 301) → relatedStudy → EMERGE (Study 302) ⓘ