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 Aduhelm
surface form: aducanumab
drugTarget amyloid beta
drugType monoclonal antibody
evaluatesDrug Aduhelm
Aduhelm
surface form: aducanumab
geographicScope multinational
hasPhase Phase 3
indication Alzheimer's disease
surface form: 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 of America
surface form: 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)