ENGAGE (Study 301)
E133124
ENGAGE (Study 301) is a large Phase 3 clinical trial designed to evaluate the efficacy and safety of the anti-amyloid monoclonal antibody aducanumab (Aduhelm) in patients with early Alzheimer’s disease.
All labels observed (1)
| Label | Occurrences |
|---|---|
| ENGAGE (Study 301) canonical | 2 |
Statements (49)
| Predicate | Object |
|---|---|
| instanceOf |
Phase 3 clinical trial
ⓘ
multicenter clinical study ⓘ randomized controlled trial ⓘ |
| ageGroup | adult ⓘ |
| controlType | placebo ⓘ |
| coSponsor | Eisai ⓘ |
| dataTypeCollected |
biomarker data
ⓘ
clinical outcomes ⓘ neuroimaging data ⓘ neuropsychological test scores ⓘ |
| design |
double-blind
ⓘ
parallel-group ⓘ placebo-controlled ⓘ randomized ⓘ |
| diseaseArea |
neurodegenerative disorders
ⓘ
neurology ⓘ |
| drugClass | anti-amyloid monoclonal antibody ⓘ |
| evaluatesDrug |
Aduhelm
ⓘ
Aduhelm ⓘ
surface form:
aducanumab
|
| fullName | ENGAGE Phase 3 Study 301 ⓘ |
| geographicScope | multinational ⓘ |
| indication |
early Alzheimer’s disease
ⓘ
mild Alzheimer’s disease dementia ⓘ mild cognitive impairment due to Alzheimer’s disease ⓘ |
| interventionType | intravenous infusion of aducanumab ⓘ |
| mechanismOfAction | selective binding to aggregated forms of amyloid beta ⓘ |
| moleculeType | human monoclonal antibody ⓘ |
| phase | Phase 3 ⓘ |
| population | patients with early symptomatic Alzheimer’s disease ⓘ |
| primaryEndpoint | change from baseline in Clinical Dementia Rating–Sum of Boxes (CDR-SB) ⓘ |
| primaryEndpointType | clinical efficacy ⓘ |
| primaryObjective | evaluate efficacy of aducanumab in early Alzheimer’s disease ⓘ |
| relatedStudy | EMERGE (Study 302) ⓘ |
| routeOfAdministration | intravenous ⓘ |
| safetyAssessment |
adverse events monitoring
ⓘ
amyloid-related imaging abnormalities (ARIA) ⓘ |
| safetyPopulation | patients receiving aducanumab and placebo ⓘ |
| secondaryEndpoint |
CSF biomarker measures
ⓘ
amyloid PET imaging measures ⓘ change from baseline in Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog) ⓘ change from baseline in Alzheimer’s Disease Cooperative Study–Activities of Daily Living (ADCS-ADL) ⓘ change from baseline in Mini-Mental State Examination (MMSE) ⓘ |
| secondaryObjective | evaluate safety of aducanumab in early Alzheimer’s disease ⓘ |
| sponsor | Biogen ⓘ |
| sponsorCountry |
United States of America
ⓘ
surface form:
United States
|
| sponsorProgram |
Aduhelm
ⓘ
surface form:
aducanumab Phase 3 program
|
| targetsPathology | amyloid beta plaques ⓘ |
| therapeuticArea | Alzheimer’s disease ⓘ |
| therapeuticGoal | slow clinical decline in early Alzheimer’s disease ⓘ |
Referenced by (2)
Full triples — surface form annotated when it differs from this entity's canonical label.