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

How this entity was disambiguated

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 ⓘ
linked to: 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 lecanemab ⓘ
linked to: Leqembi
drugMechanism anti-amyloid monoclonal antibody ⓘ
drugTarget aggregated amyloid beta ⓘ
evaluatesDrug Leqembi ⓘ
lecanemab ⓘ
linked to: Leqembi
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 ⓘ
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 ⓘ

How these facts were elicited

Referenced by (1)

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

Leqembi → hasKeyClinicalTrial → CLARITY AD ⓘ