221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease (EMERGE)
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ClinicalTrials.gov Identifier: NCT02484547 |
Recruitment Status :
Active, not recruiting
First Posted : June 29, 2015
Last Update Posted : August 6, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer's Disease | Drug: Aducanumab (BIIB037) Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1605 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects With Early Alzheimer's Disease |
Actual Study Start Date : | September 30, 2015 |
Estimated Primary Completion Date : | January 30, 2020 |
Estimated Study Completion Date : | April 30, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Low Dose
Monthly intravenous (IV) infusions
|
Drug: Aducanumab (BIIB037)
Low dose Drug: Placebo Placebo |
Experimental: High Dose
Monthly intravenous (IV) infusions
|
Drug: Aducanumab (BIIB037)
High dose Drug: Placebo Placebo |
- Change from baseline in CDR-SB score [ Time Frame: Week 78 ]
- Change from baseline in MMSE score [ Time Frame: Week 78 ]
- Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (13 items) (ADAS-Cog 13) [ Time Frame: Week 78 ]
- Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) (ADCS-ADL-MCI) score [ Time Frame: Week 78 ]

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Ages Eligible for Study: | 50 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Must meet all of the following clinical criteria for MCI due to AD or mild AD and must have:
- A Clinical Dementia Rating (CDR)-Global Score of 0.5.
- Objective evidence of cognitive impairment at screening
- An MMSE score between 24 and 30 (inclusive)
- Must have a positive amyloid Positron Emission Tomography (PET) scan
- Must consent to apolipoprotein E (ApoE) genotyping
- If using drugs to treat symptoms related to AD, doses must be stable for at least 8 weeks prior to screening visit 1
- Must have a reliable informant or caregiver
Key Exclusion Criteria:
- Any medical or neurological condition (other than Alzheimer's Disease) that might be a contributing cause of the subject's cognitive impairment
- Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year
- Clinically significant unstable psychiatric illness in past 6 months
- History of unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to Screening
- Indication of impaired renal or liver function
- Have human immunodeficiency virus (HIV) infection
- Have a significant systematic illness or infection in past 30 days
- Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities
- Any contraindications to brain magnetic resonance imaging (MRI) or PET scans
- Alcohol or substance abuse in past 1 year
- Taking blood thinners (except for aspirin at a prophylactic dose or less)
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02484547

Study Director: | Medical Director | Biogen |
Additional Information:
Responsible Party: | Biogen |
ClinicalTrials.gov Identifier: | NCT02484547 History of Changes |
Other Study ID Numbers: |
221AD302 2015-000967-15 ( EudraCT Number ) |
First Posted: | June 29, 2015 Key Record Dates |
Last Update Posted: | August 6, 2018 |
Last Verified: | August 2018 |
Keywords provided by Biogen:
Aducanumab BIIB037 |
Additional relevant MeSH terms:
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |