EVOLVE

TerminatedPhase 2Results posted

A Study of Aducanumab in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease Dementia to Evaluate the Safety of Continued Dosing in Participants With Asymptomatic Amyloid-Related Imaging Abnormalities

A Phase 2, Multicenter, Randomized, Parallel-Group, Double-Blind, Controlled Study of Aducanumab (BIIB037) in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease Dementia to Evaluate the Safety of Continued Dosing in Subjects With Asymptomatic Amyloid-Related Imaging Abnormalities

Lead sponsor

Biogen

Asset

Aducanumab

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•MCI due to AD / mild AD dementia•CDR global 0.5•MMSE 24-30

Primary endpoint

•Clinically Impactful Amyloid-related Imaging Abnormalities (ARIA)

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 number2018-002102-31

Org study ID221AD205

NCT IDNCT03639987

Timeline

Milestones

Study first posted2018-08-21actual

Study start2018-12-20actual

Primary completion2019-07-30actual

Study completion2019-07-30actual

Last update posted2021-09-16actual

Results first posted2021-09-16actual

Assets

Drug assets

Aducanumab

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

Inclusion/ Exclusion Criteria

Key Inclusion Criteria:

•Ability of the participant or his/her legally authorized representative to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local participant privacy regulations.

•Must have at least 6 years of education or work experience to exclude mental deficits other than MCI due to AD or mild AD dementia.

•Must have evidence of cerebral Aβ accumulation, based on a positive PET scan of the brain. Previously obtained positron emission tomography (PET) scan (within 12 months of screening) is permissible. Previous PET scan images must be submitted to the central imaging vendor to confirm that study inclusion criteria are met.

•Must consent to apolipoprotein E (ApoE) genotyping.

•Must meet all of the following clinical criteria for MCI due to AD or mild AD dementia according to NIA-AA criteria [Albert 2011; McKhann 2011], and must have the following: MCI due to AD (a CDR global score of 0.5, and an MMSE score between 24 and 30 (inclusive)), or Mild AD dementia (a CDR global score of 0.5 or 1, and as MMSE score between 20 and 26 (inclusive))

Exclusion criteria

•Any uncontrolled medical or neurological/neurodegenerative condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause of the participant's cognitive impairment (e.g., substance abuse, vitamin B12 deficiency, abnormal thyroid function, stroke or other cerebrovascular condition, Lewy body dementia, frontotemporal dementia, head trauma).

•Clinically significant unstable psychiatric illness (e.g., uncontrolled major depression, uncontrolled schizophrenia, uncontrolled bipolar affective disorder) within 6 months prior to Screening.

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

•Vaccinations within 10 days prior to randomization (Day 1).

•Female participants who are pregnant or currently breastfeeding.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Endpoints (22)

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

Neuroimaging

Other (unclassified)

Global cognition

Amyloid biomarkers

Safety / tolerability / PK

Global cognition

2 endpoints

Secondary/protocol endpoint

Change From Baseline in the Montreal Cognitive Assessment (MoCA) at Week 54

Time frame:Baseline, Week 54

Montreal Cognitive Assessment (MoCA)

change from baseline, improvement

Secondary/registry result

Change From Baseline in the Montreal Cognitive Assessment (MoCA) at Week 54

Time frame:Baseline, Week 54

Montreal Cognitive Assessment (MoCA)

change from baseline, improvement

Amyloid biomarkers

2 endpoints

Primary/protocol endpoint

Number of Participants With Clinically Impactful Amyloid-related Imaging Abnormalities (ARIA)

Time frame:up to Week 54

event count, event

Primary/registry result

Number of Participants With Clinically Impactful Amyloid-related Imaging Abnormalities (ARIA)

Time frame:up to Week 54

event count, event

Neuroimaging

8 endpoints

Secondary/protocol endpoint

Number of Participants With ARIA by Severity as Obtained on Magnetic Resonance Imaging (MRI)

Time frame:up to Week 54

event count, event

Secondary/protocol endpoint

Time to Onset of ARIA as Obtained on MRI

Time frame:up to Week 54

time to event, event

Secondary/protocol endpoint

Time to Resolution of ARIA as Obtained on MRI

Time frame:up to Week 54

time to event, event

Secondary/protocol endpoint

Number of Participants With Symptomatic ARIA by Severity

Time frame:up to Week 54

event count, event

Secondary/registry result

Number of Participants With ARIA by Severity as Obtained on Magnetic Resonance Imaging (MRI)

Time frame:up to Week 54

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Group 1n=26 Participants	2	-
Group 2n=26 Participants	0	-

Secondary/registry result

Time to Onset of ARIA as Obtained on MRI

Time frame:up to Week 54

time to event, event

Secondary/registry result

Time to Resolution of ARIA as Obtained on MRI

Time frame:up to Week 54

time to event, event

Secondary/registry result

Number of Participants With Symptomatic ARIA by Severity

Time frame:up to Week 54

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Group 1n=26 Participants	1	-
Group 2n=26 Participants	0	-

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame:up to Week 54

event count, event

Secondary/registry result

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame:up to Week 54

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Group 1AEsn=26 Participants	15	-
SAEsn=26 Participants	2	-
Group 2AEsn=26 Participants	9	-
SAEsn=26 Participants	0	-

Other (unclassified)

8 endpoints

Secondary/protocol endpoint/low confidence

Time to Onset of Symptomatic ARIA

Time frame:up to Week 54

time to event, event

Secondary/protocol endpoint/low confidence

Time to Resolution of Symptomatic ARIA

Time frame:up to Week 54

time to event, event

Secondary/protocol endpoint/low confidence

Number of Participants With Aducanumab Concentration in Serum

Time frame:up to Week 54

concentration, descriptive

Secondary/protocol endpoint/low confidence

Number of Participants With Antiaducanumab Antibodies in Serum

Time frame:up to Week 54

event count, event

Secondary/registry result/low confidence

Time to Onset of Symptomatic ARIA

Time frame:up to Week 54

time to event, event

Secondary/registry result/low confidence

Time to Resolution of Symptomatic ARIA

Time frame:up to Week 54

time to event, event

Secondary/registry result/low confidence

Number of Participants With Aducanumab Concentration in Serum

Time frame:up to Week 54

concentration, descriptive

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Group 1n=26 Participants	1	-
Group 2n=26 Participants	1	-

Secondary/registry result/low confidence

Number of Participants With Antiaducanumab Antibodies in Serum

Time frame:up to Week 54

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Group 1n=26 Participants	0	-
Group 2n=26 Participants	0	-

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.