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 |
How this entity was disambiguated
This entity first appeared as the object of triple T1172238 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.
NED1
Entity disambiguation (via context triple)
gpt-5-mini-2025-08-07
Target entity: ENGAGE (Study 301) Context triple: [Aduhelm, clinicalTrial, ENGAGE (Study 301)]
-
A.
Study 301
Study 301 is a pivotal clinical trial evaluating the efficacy and safety of the Alzheimer’s disease drug Leqembi (lecanemab) in patients with early-stage disease.
-
B.
Jackson Heart Study
The Jackson Heart Study is a large, long-term epidemiological research project focused on understanding cardiovascular disease and its risk factors among African American communities, particularly in Jackson, Mississippi.
-
C.
ICH E2A Clinical Safety Data Management
ICH E2A Clinical Safety Data Management is an international guideline that standardizes the collection, reporting, and evaluation of clinical safety data in drug development to support consistent pharmacovigilance and regulatory decision-making.
-
D.
Intramural Research Program on Aging
The Intramural Research Program on Aging is a U.S. federal biomedical research program that conducts laboratory, clinical, and population studies to understand the biology of aging and age-related diseases.
-
E.
Multi-Ethnic Study of Atherosclerosis
The Multi-Ethnic Study of Atherosclerosis is a long-term, population-based medical research study that investigates the prevalence, progression, and risk factors of cardiovascular disease across diverse ethnic groups in the United States.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
NED2
Entity disambiguation (via description)
gpt-5-mini-2025-08-07
Target entity: ENGAGE (Study 301) Target entity description: 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.
-
A.
Study 301
Study 301 is a pivotal clinical trial evaluating the efficacy and safety of the Alzheimer’s disease drug Leqembi (lecanemab) in patients with early-stage disease.
-
B.
Jackson Heart Study
The Jackson Heart Study is a large, long-term epidemiological research project focused on understanding cardiovascular disease and its risk factors among African American communities, particularly in Jackson, Mississippi.
-
C.
ICH E2A Clinical Safety Data Management
ICH E2A Clinical Safety Data Management is an international guideline that standardizes the collection, reporting, and evaluation of clinical safety data in drug development to support consistent pharmacovigilance and regulatory decision-making.
-
D.
Intramural Research Program on Aging
The Intramural Research Program on Aging is a U.S. federal biomedical research program that conducts laboratory, clinical, and population studies to understand the biology of aging and age-related diseases.
-
E.
Multi-Ethnic Study of Atherosclerosis
The Multi-Ethnic Study of Atherosclerosis is a long-term, population-based medical research study that investigates the prevalence, progression, and risk factors of cardiovascular disease across diverse ethnic groups in the United States.
- F. None of above. chosen
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 ⓘ |
How these facts were elicited
The pipeline generated the facts above by prompting gpt-5.1 with this entity's name + description and the instruction below.
Instruction
You are a knowledge base construction expert. Given a subject entity and a description of it, return factual statements that you know for the subject as a JSON list of dictionaries(triples), where keys must be "subject", "predicate" and "object". The number of facts may be very high, between 25 to 50 or more, for very popular subjects. For less popular subjects, the number of facts can be very low, like 5 or 10. # Requirements - If you don't know the subject at all, return an empty list. - If the subject is not a named entity, return an empty list. - Include at least one triple where predicate is "instanceOf". - Do not get too wordy. - Separate several objects into multiple triples with one object.
Input
Subject: ENGAGE (Study 301) Description of subject: 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.
Referenced by (2)
Full triples — surface form annotated when it differs from this entity's canonical label.