CLARITY AD

E125383

CLARITY AD is a pivotal phase 3 clinical trial that evaluated the efficacy and safety of the anti-amyloid Alzheimer’s disease drug lecanemab (Leqembi) in patients with early Alzheimer’s disease.

All labels observed (1)

Label Occurrences
CLARITY AD canonical 1

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Statements (47)

Predicate Object
instanceOf Alzheimer’s disease clinical trial
phase 3 clinical trial
allocation parallel assignment
blinding double-blind
coDevelopment Eisai and Biogen
conditionStudied Alzheimer's disease
surface form: Alzheimer’s disease
controlGroup placebo-treated participants
controlType placebo
coSponsor Biogen
design double-blind
placebo-controlled
randomized
drugBrandName Leqembi
drugClass disease-modifying therapy for Alzheimer’s disease
drugGenericName Leqembi
surface form: lecanemab
drugMechanism anti-amyloid monoclonal antibody
drugTarget aggregated amyloid beta
evaluatesDrug Leqembi
Leqembi
surface form: lecanemab
experimentalGroup lecanemab-treated participants
geographicScope multinational
indication early Alzheimer’s disease
mild Alzheimer’s disease dementia
mild cognitive impairment due to Alzheimer’s disease
interventionType intravenous lecanemab
phase Phase 3
population patients with early symptomatic Alzheimer’s disease
populationRequirement evidence of brain amyloid pathology
primaryEndpointType clinical efficacy
cognitive and functional outcomes
primaryObjective evaluate efficacy of lecanemab in early Alzheimer’s disease
relatedRegulatoryOutcome support for FDA approval of lecanemab
support for regulatory submissions for Leqembi
safetyEndpointType adverse events
amyloid-related imaging abnormalities
safetyFocus monitoring of ARIA-E
monitoring of ARIA-H
secondaryObjective evaluate safety of lecanemab in early Alzheimer’s disease
sponsor Eisai
sponsorCountry Japan
United States of America
surface form: United States
sponsorRole Eisai as lead sponsor
targetPathology amyloid beta
therapeuticArea neurodegenerative disease
neurology
trialRoleInField pivotal evidence for anti-amyloid therapy in early Alzheimer’s disease
trialType interventional

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Referenced by (1)

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

Leqembi hasKeyClinicalTrial CLARITY AD