ENVISION

TerminatedPhase 3Results posted

A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer's Disease

A Phase 3b/4 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Verify the Clinical Benefit of Aducanumab (BIIB037) in Participants With Alzheimer's Disease

Lead sponsor

Biogen

Asset

Aducanumab

Listed sites

265

Recruiting sites

Enrollment

1,027

actual

Study population

Alzheimer’s disease

Key I/E criteria

•MCI due to AD•Amyloid biomarker required (PET/CSF)•MMSE 22-30

Primary endpoint

•Clinical Dementia Rating-Sum of Boxes (CDR-SB)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Eudract number2022-001671-14

Org study ID221AD305

NCT IDNCT05310071

Timeline

Milestones

Study first posted2022-04-04actual

Study start2022-06-02actual

Primary completion2024-08-12actual

Study completion2024-08-12actual

Last update posted2025-04-23actual

Results first posted2025-04-23actual

Assets

Drug assets

Aducanumab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

Key Inclusion Criteria:

•The participant must have confirmed amyloid beta pathology by cerebrospinal fluid (CSF) or amyloid PET

•Must have a history of subjective memory decline with gradual onset and slow progression over the 6 months before Screening, confirmed by study partner

•The participant must have 1 informant/care partner who, in the Investigator's opinion, has frequent and sufficient contact with the participant (at least 10 hours/week in person or by phone) as to be able to provide accurate information about the participant's cognitive and functional abilities over time

•Must meet all of the following clinical criteria for MCI due to Alzheimer's disease or mild Alzheimer's disease according to National Institute on Aging and Alzheimer's Association (NIA-AA) criteria

1. Have an MMSE score between 22 and 30 inclusive

2. Have a CDR memory score >0.5

3. Have a Clinical Dementia Rating Scale Global Score (CDR-GS) of 0.5 or 1.0

4. Have a Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score of 85 or lower indicative of objective cognitive impairment

•Apart from a clinical diagnosis of early Alzheimer's disease, the participant must be in good health as determined by the Investigator based on medical history and screening assessments

•Must consent to apolipoprotein E (ApoE) genotyping. (Note: Participants are not required to be ApoE ε4 carriers)

Exclusion criteria

•Any uncontrolled medical or neurological/neurodegenerative condition (other than Alzheimer's disease) that, in the opinion of the Investigator, might be a contributing cause of the participant's cognitive impairment

•Clinically significant and/or unstable psychiatric illness within 6 months prior to Screening

•Transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year prior to Screening

•History of severe allergic or anaphylactic reactions or of hypersensitivity to any of the inactive ingredients in the drug product

•Participation in any study with purported disease-modifying effect in Alzheimer's disease within 12 months prior to Screening unless documentation of receipt of placebo is available

•Current use or previous use of medications with a purported disease-modifying effect in Alzheimer's disease, outside of investigational studies

•Use of any medications that, in the opinion of the Investigator, may contribute to cognitive impairment, put the participant at higher risk for AEs, or impair the participant's ability to perform cognitive testing or complete study procedures

•Use of any investigational drug

•Prior exposure to aducanumab either commercially or by participation in a previous study with aducanumab. (Participants are eligible if they did not receive active aducanumab.)

•A negative PET scan result with any amyloid-targeting ligand within 12 months prior to Screening

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Endpoints (20)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Function / daily living

Behavior / neuropsychiatric

Amyloid biomarkers

Tau biomarkers

Global cognition

10 endpoints

Primary/protocol endpoint

Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score at Week 78

Time frame:Baseline, Week 78

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Primary/registry result

Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score at Week 78

Time frame:Baseline, Week 78

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Placebon=6 Participants	0.67	0.408
Aducanumabn=8 Participants	1.56	1.635

Secondary/protocol endpoint

Change From Baseline in Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog13) at Weeks 78 and 106

Time frame:Baseline, Weeks 78 and 106

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Mini-Mental State Examination (MMSE) Scale Score at Weeks 78 and 106

Time frame:Baseline, Weeks 78 and 106

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in CDR-SB Score at Week 106

Time frame:Baseline, Week 106

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Global Statistical Test (GST) Composite Z-Score at Weeks 78 and 106

Time frame:Baseline, Weeks 78 and 106

ADAS-Cog

change from baseline, improvement

Secondary/registry result

Change From Baseline in Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog13) at Weeks 78 and 106

Time frame:Baseline, Weeks 78 and 106

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Placebon=3 Participants	9.667	0.8844
Aducanumabn=5 Participants	7.396	2.3262

Secondary/registry result

Change From Baseline in Mini-Mental State Examination (MMSE) Scale Score at Weeks 78 and 106

Time frame:Baseline, Weeks 78 and 106

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Placebon=3 Participants	-6.0	1.00
Aducanumabn=5 Participants	-1.2	1.48

Secondary/registry result

Change From Baseline in CDR-SB Score at Week 106

Time frame:Baseline, Week 106

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Global Statistical Test (GST) Composite Z-Score at Weeks 78 and 106

Time frame:Baseline, Weeks 78 and 106

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), z-score	Standard deviation
Placebon=3 Participants	0.88	0.116
Aducanumabn=4 Participants	0.48	0.515

Function / daily living

4 endpoints

Secondary/protocol endpoint

Change From Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Score at Weeks 78 and 106

Time frame:Baseline, Weeks 78 and 106

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Alzheimer's Disease Cooperative Study for Activities of Daily Living in Mild Cognitive Impairment (ADCS-ADL-MCI) Scale Score at Weeks 78 and 106

Time frame:Baseline, Weeks 78 and 106

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Score at Weeks 78 and 106

Time frame:Baseline, Weeks 78 and 106

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Placebon=3 Participants	-14.667	4.4869
Aducanumabn=5 Participants	-7.796	6.7805

Secondary/registry result

Change From Baseline in Alzheimer's Disease Cooperative Study for Activities of Daily Living in Mild Cognitive Impairment (ADCS-ADL-MCI) Scale Score at Weeks 78 and 106

Time frame:Baseline, Weeks 78 and 106

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Placebon=3 Participants	-5.0	3.61
Aducanumabn=5 Participants	-0.4	7.60

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Neuropsychiatric Inventory-10 (NPI-10) Score at Weeks 78 and 106

Time frame:Baseline, Weeks 78 and 106

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Neuropsychiatric Inventory-10 (NPI-10) Score at Weeks 78 and 106

Time frame:Baseline, Weeks 78 and 106

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
Placebon=3 Participants	-8.3	16.20
Aducanumabn=5 Participants	-1.8	6.94

Amyloid biomarkers

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Amyloid Positron Emission Tomography (PET) Signal at Weeks 78 and 104

Time frame:Baseline, Weeks 78 and 104

Amyloid PET Centiloid

change from baseline, improvement

Secondary/registry result

Change From Baseline in Amyloid Positron Emission Tomography (PET) Signal at Weeks 78 and 104

Time frame:Baseline, Weeks 78 and 104

Amyloid PET Centiloid

change from baseline, improvement

Posted result

Group	Value (mean), SUVR	Standard deviation
Aducanumabn=1 Participants	-2.360	NA

Tau biomarkers

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Tau PET Signal at Weeks 78 and 104

Time frame:Baseline, Weeks 78 and 104

change from baseline, improvement

Secondary/registry result

Change From Baseline in Tau PET Signal at Weeks 78 and 104

Time frame:Baseline, Weeks 78 and 104

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.