AzTrials
AzTrials

Alzheimer's DiseasePhase 3EMERGENCT02484547

221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease

A Phase 3 study testing Aducanumab (BIIB037) in people with Alzheimer's Disease, run by Biogen at 180 sites in 13 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
Aducanumab (BIIB037)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,643 participants
Where
180 sitesin 13 countries
Study dates
15 Sep 2015to 5 Aug 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

180 sites in 13 countries.

180 sites in 13 countries

United States58 sites

  • Lehigh Center for Clinical Research, LLC

    Allentown, Pennsylvania, 18104

  • Emory University Cognitive Neurology Clinic & ADRC

    Atlanta, Georgia, 30329

  • JEM Research Institute

    Atlantis, Florida, 33462

  • University Of Colorado Denver

    Aurora, Colorado, 80045

  • Senior Adult Specialty Research

    Austin, Texas, 78757

  • McLean Hospital

    Belmont, Massachusetts, 02478

  • Clinical Neuroscience Research Association, Inc

    Bennington, Vermont, 05201

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Bradenton Research Center, Inc.

    Bradenton, Florida, 34205

  • Meridien Research

    Brooksville, Florida, 34601

  • Medical Research Health and Education Foundation, Inc

    Columbus, Georgia, 31909

  • NeuroStudies.net, LLC

    Decatur, Georgia, 30033

  • Quantum Laboratories Inc.

    Deerfield Beach, Florida, 33064

  • Ohio State University Medical Center

    Dublin, Ohio, 43017

  • Associated Neurologists of Southern Connecticut, PC

    Fairfield, Connecticut, 06824

  • Hattiesburg Clinic, PA

    Hattiesburg, Mississippi, 39401

  • Infinity Clinical Research, LLC

    Hollywood, Florida, 33021

  • The Methodist Hospital Research Institute

    Houston, Texas, 77030

  • Clinical Trial Network

    Houston, Texas, 77074

  • Josephson, Wallack, Munshower Neurology, PC

    Indianapolis, Indiana, 46256

  • Institute for Memory Impairments

    Irvine, California, 92607

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Las Vegas, Nevada, 89106

  • Empire Neurology, PC

    Latham, New York, 12110

  • AdvanceMed Research

    Lawrenceville, New Jersey, 08648

  • Renewal Behavioral Health

    Long Beach, California, 85013

  • USC Keck School of Medicine

    Los Angeles, California, 90033

  • Yale University School Of Medicine

    New Haven, Connecticut, 06520

  • Weill Cornell Medical College-New York Presbyterian Hospital

    New York, New York, 10021

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

  • Boston Center for Memory

    Newton, Massachusetts, 05201

  • Roper St. Francis Healthcare

    North Charleston, South Carolina, 29406-6076

  • Research Center for Clinical Studies, Inc.

    Norwalk, Connecticut, 06851

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Excell Research, Inc.

    Oceanside, California, 92056

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32801

  • Pacific Neuroscience Medical Group

    Oxnard, California, 93030

  • Penn Memory Center

    Philadelphia, Pennsylvania, 19104

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

  • Xenoscience Inc.

    Phoenix, Arizona, 85013

  • ActivMed Practices & Research

    Portsmouth, New Hampshire, 03801

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Anderson Clinical Research

    Redlands, California, 92354

  • University of Utah Health Sciences Center

    Salt Lake City, Utah, 84132

  • Pacific Research Network

    San Diego, California, 92103

  • University of California San Diego Medical Center

    San Diego, California, 92103

  • California Pacific Medical Center

    San Francisco, California, 94114

  • Syrentis Clinical Research

    Santa Ana, California, 92705

  • St Joseph Heritage Healthcare

    Santa Rosa, California, 95403

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Northwest Neurological, PLLC

    Spokane, Washington, 99202

  • Stanford University Medical Center

    Stanford, California, 94305

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33609

  • IMMUNOe International Research Centers

    Thornton, Colorado, 80233

  • PMG Research of Winston-Salem, LLC

    Winston-Salem, North Carolina, 27103

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27103

Other trials in United States

Japan27 sites

  • Research Site

    Amagasaki-shi, Hyōgo, 660-8511

  • Research Site

    Fukuoka, Fukuoka, 814-0180

  • Research site

    Himeji-shi, Hyōgo, 670-0981

  • Research Site

    Himeji-shi, Hyōgo, 672-8043

  • Research Site

    Iwata-shi, Shizuoka, 438-0043

  • Research Site

    Kishiwada-shi, Osaka, 596-8522

  • Research Site

    Kita-gun, Kagawa-ken, 761-0793

  • Research Site

    Kobe, Hyōgo, 650-0047

  • Research Site

    Kurashiki-shi, Okayama-ken, 710-0813

  • Research Site

    Kurume-shi, Fukuoka, 830-0011

  • Research Site

    Kyoto, Kyoto, 607-8113

  • Research Site

    Kyoto, Kyoto, 616-8255

  • Research Site

    Nishisonogi, Nagasaki, 851-2103

  • Research Site

    Obu-shi, Aichi-ken, 474-8511

  • Research Site

    Okayama, Okayama-ken, 703-8265

  • Research Site

    Osaka, Osaka, 530-0001

  • Research Site

    Osaka, Osaka, 545-8586

  • Research Site

    Osaka, Osaka, 553-0003

  • Research Site

    Otake-shi, Hiroshima, 739-0696

  • Research Site

    Sennan-shi, Osaka, 590-0503

  • Research Site

    Shizuoka, Shizuoka, 420-8688

  • Research Site

    Shizuoka, Shizuoka, 424-8636

  • Research Site

    Suita-shi, Osaka, 565-0871

  • Research Site

    Toon-shi, Ehime, 791-0295

  • Research Site

    Tsu, Mie-ken, 514-8507

  • Research Site

    Tsukuba-gun, Okayama-ken, 701-0304

  • Research Site

    Yufu-shi, Oita Prefecture, 879-5593

Other trials in Japan

Germany19 sites

  • Klinikum Altenburger Land GmbH

    Altenburg, Thuringia, 04600

  • Klinik Hohe Warte Bayreuth

    Bayreuth, Bavaria, 95445

  • emovis GmbH

    Berlin, 10629

  • Neurologie im Tempelhofer Hafen

    Berlin, 12099

  • Schwerpunktpraxis fuer Neurologie, Psychiatrie und Klinische Studien

    Bielefeld, North Rhine-Westphalia, 33647

  • Klinikum Chemnitz gGmbH

    Chemnitz, Saxony, 09131

  • Universitaetsklinikum Duesseldorf AoeR

    Düsseldorf, North Rhine-Westphalia, 40629

  • Neuro Centrum Odenwald

    Erbach im Odenwald, Hesse, 64711

  • Bezirkskrankenhaus Guenzburg

    Gunzburg, Baden-Wurttemberg, 89312

  • Kopfzentrum Leipzig

    Leipzig, Saxony, 04275

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

    Mainz, Rhineland-Palatinate, 55131

  • ISPG - Institut fuer Studien zur Psychischen Gesundheit

    Mannheim, Baden-Wurttemberg, 68165

  • Institut fuer Schlaganfall- und Demenzforschung (ISD)

    Munich, Bavaria, 81377

  • Klinikum rechts der Isar der TU Muenchen

    Munich, Bavaria, 81675

  • Universitaetsklinikum Muenster

    Münster, North Rhine-Westphalia, 48149

  • Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung

    Siegen, North Rhine-Westphalia, 57076

  • Nervenfachaerztlichen Gemeinschaftspraxis Ulm

    Ulm, Baden-Wurttemberg, 89078

  • Universitaetsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

  • Neuropraxis Muenchen Sued

    Unterhaching, Bavaria, 82008

Other trials in Germany

Poland14 sites

  • Podlaskie Centrum Psychogeriatrii

    Bialystok, 15-732

  • PALLMED Sp. z o.o.

    Bydgoszcz, 85-796

  • Uniwersyteckie Centrum Kliniczne

    Gdansk

  • Novo-Med Zielinski i wspolnicy Sp. j.

    Katowice, 40-650

  • SPZOZ Centralny Szpital Kliniczny UM w Lodzi

    Lodz, 92-216

  • Centrum Diagnostyczno - Terapeutyczne "MEDICUS" Sp.z o.o.

    Lubin, 59-300

  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

    Lublin, 20-950

  • Neurologiczny NZOZ Centrum Leczenia SM

    Plewiska, 62-064

  • NZOZ "NEURO-KARD", "Ilkowski i Partnerzy" Sp. Partn. Lek.

    Poznan, 61-853

  • Centrum Medyczne Medyk

    Rzeszów, 35-055

  • Neuro-Care Gabriela Klodowska

    Śląskie, 41-100

  • NZOZ "SENIOR" Poradnia Psychogeriatryczna

    Sopot, 81-855

  • Osrodek Badan Klinicznych EUROMEDIS

    Szczecin, 70-111

  • mMED Maciej Czarnecki

    Warsaw, 01-697

Other trials in Poland

Canada13 sites

  • JBN Medical Diagnostic Services Inc.

    Burlington, Ontario, L7M 4Y1

  • Recherches Neuro-Hippocampe Inc.

    Gatineau, Quebec, J8T 8J1

  • Recherche Sepmus, Inc.

    Greenfield Park, Quebec, J4V 2J2

  • True North Clinical Research - Halifax Inc.

    Halifax, Nova Scotia, B3S 1M7

  • Health Research.

    Kamloops, British Columbia

  • True North Clinical Research Kentville, Inc

    Kentville, Nova Scotia, B4N 4K9

  • St. Joseph's HC- Parkwood Institute

    London, Ontario, N6C 5J1

  • Bruyere Continuing Care

    Ottawa, Ontario, K1N 5C8

  • Kawartha Regional Memory Clinic

    Peterborough, Ontario, K9H 2P4

  • DIEX Recherche Sherbrooke Inc.

    Sherbrooke, Quebec, J1H 1Z1

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

  • Douglas Hospital Research Centre

    Verdun, Quebec, H4H 1R3

  • Health Research

    West Vancouver, British Columbia

Other trials in Canada

France9 sites

  • Hopital Roger Salengro - CHU Lille

    Lille, Nord, 59037

  • Hôpital de la Timone

    Marseille, Bouches-du-Rhône, 13385

  • Hôpital Gui de Chauliac

    Montpellier, Herault, 34295

  • CHU Nantes - Hopital Nord Laënnec

    Nantes, Loire Atlantique, 44093

  • Hôpital Fernand Widal

    Paris, 75010

  • CHU Rennes - Hopital Pontchaillou

    Rennes, Ille Et Vilaine, 35033

  • Centre de Recherche Clinique du Gérontopôle - Cité de la Santé

    Toulouse, Haute Garonne, 31052

  • CHU de Toulouse - Hôpital Purpan

    Toulouse, Haute Garonne, 31059

  • Hôpital des Charpennes

    Villeurbanne, Rhone, 69100

Other trials in France

Spain9 sites

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitari Quiron Dexeus

    Barcelona, 08028

  • Hospital Universitari de Bellvitge

    Barcelona, 8907

  • Hospital Universitario Reina Sofía

    Córdoba, Córdoba, 14011

  • Hospital General Universitario de Elche

    Elche, Alicante, 3203

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198

  • ALTHAIA Hospital Sant Joan de Deu

    Manresa, Barcelona, 08243

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario Virgen Macarena

    Seville, 41009

Other trials in Spain

Belgium8 sites

  • A.Z. Klina

    Brasschaat

  • AZ Sint-Jan Brugge

    Bruges, 8000

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

  • Centre Neurologique & de Réadaptation Fonctionnelle

    Fraiture, 4557

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • AZ Groeninge - Campus Kennedylaan

    Kortrijk, 8500

  • UZ Leuven

    Leuven, 3000

  • AZ Delta

    Roeselare, 8800

Other trials in Belgium

Italy8 sites

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, 20133

  • ASST di Monza

    Monza, Milano, 20052

  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

    Palermo, 90100

  • Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia

    Perugia, 06156

  • Ospedale degli Infermi

    Ponderano, Biella, 13875

  • Fondazione Santa Lucia IRCCS

    Roma, 00179

  • Umberto I Pol. di Roma-Università di Roma La Sapienza

    Roma, 00185

  • Azienda Ospedaliera Card. G. Panico

    Tricase, Lecce, 73039

Other trials in Italy

Switzerland6 sites

  • Universitären Psychiatrischen Kliniken Basel (UPK)

    Basel, 4025

  • Medizinisches Zentrum MZB Biel

    Biel/Bienne, 2502

  • Hôpitaux Universitaires de Genève - HUG

    Geneva, 1211

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

  • Ospedale Civico

    Lugano, 6903

  • Institut fuer Regenerative Medizin (IREM) der Universitaet Zuerich, Zentrum fuer Praevention und Demenztherapie

    Schlieren, 8952

Other trials in Switzerland

Sweden4 sites

  • Skånes Universitetssjukhus, Malmö

    Malmö, 20502

  • Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus

    Mölndal, 43141

  • Karolinska Universitetssjukhuset, Huddinge

    Stockholm, 14186

  • Akademiska Sjukhuset

    Uppsala, 75185

Other trials in Sweden

Finland3 sites

  • Terveystalo Kamppi

    Helsinki, 00100

  • Itä-Suomen yliopisto, Aivotutkimusyksikkö

    Kuopio, 70210

  • CRST, Clinical Research Services Turku

    Turku, 20520

Other trials in Finland

Netherlands2 sites

  • Alzheimer Research Center

    Amsterdam, 1081 GM

  • Erasmus Medisch Centrum

    Rotterdam, 3015 CE

Other trials in Netherlands

About this study

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

The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) [ADCS-ADL-MCI].

Being tested
Aducanumab (BIIB037), Placebo
Keywords
Aducanumab, BIIB037
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aducanumab (BIIB037)Drug

    Low dose

  • Aducanumab (BIIB037)Drug

    High dose

  • PlaceboDrug

    Placebo

Study groups in NCT02484547
Study groupRoleWhat they receive
Low DoseExperimentalMonthly intravenous (IV) infusions
Receives: Drug: Aducanumab (BIIB037); Drug: Placebo
High DoseExperimentalMonthly intravenous (IV) infusions
Receives: Drug: Aducanumab (BIIB037); Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    CDR-SB integrates assessments from 3 domains of cognition (memory, orientation, judgment/problem-solving) and 3 domains of function (community affairs, home/hobbies, personal care). Following caregiver interview and systematic patient examination, the rater assigns a score describing the participant's current performance level in each of these domains of life functioning. Prespecified severity anchors range from none = 0, questionable = 0.5, mild = 1, moderate = 2 to severe = 3 (the personal care domain omits the 0.5 score). "Sum of boxes" scoring methodology sums the score for each of the 6 domains and provides a value ranging from 0 to 18 that can change in increments of 0.5 or greater. Higher scores indicate greater disease severity. Mixed model for repeated measures (MMRM) analysis was used to analyze change from baseline in CDR-SB. A positive change from baseline indicates clinical decline.

    Measured: Baseline, Week 78

Secondary outcomes (3)

  1. Change From Baseline in Mini Mental State Examination (MMSE) Score at Week 78

    The MMSE is a widely used performance-based test of global cognitive status. It consists of 11 tasks that assess orientation, word recall, attention and calculation, language abilities, and visuospatial functions. The scores from the 11 tests are combined to obtain the total score, which ranges from 0 to 30, with lower scores over time indicating increasing cognitive impairment. MMRM analysis was used to analyze change from baseline in MMSE. A negative change from baseline indicates clinical decline.

    Measured: Baseline, Week 78

  2. Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (13 Items) (ADAS-Cog 13) at Week 78

    ADAS-Cog13 comprises both cognitive tasks and clinical ratings of cognitive performance. The scale items capture word recall, ability to follow commands, the ability to correctly copy or draw an image, naming, the ability to interact with everyday objects, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure for delayed word recall and concentration/distractibility. The total score ranges from 0 to 85. An increase in score over time indicates increasing cognitive impairment. MMRM analysis was used to analyze change from baseline in ADAS-Cog 13. A positive change from baseline indicates clinical decline.

    Measured: Baseline, Week 78

  3. Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment Version) (ADCS-ADL-MCI) Score at Week 78

    The ADCS-ADL-MCI consists of 17 instrumental items (e.g., shopping, preparing meals, using household appliances) and 1 basic item (getting dressed). Ratings reflect caregiver observations about the patient's actual functioning over the previous month and provide an assessment of change in the functional state of the participant over time. The total score ranges from 0 to 53, with lower values over time reflecting functional deterioration. MMRM analysis was used to analyze change from baseline in ADAS-ADL-MCI. A negative change from baseline indicates clinical decline.

    Measured: Baseline, Week 78

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2015 (estimated)
  2. Study start15 Sep 2015
  3. Primary completion5 Aug 2019
  4. Study completion5 Aug 2019

Why it stopped: Study was discontinued based on futility analysis done and not based on safety concerns. Follow-up visits and closing out study activities are completed

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,643 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02484547
Sponsor's protocol ID
221AD302
Other IDs
2015-000967-15, 2015
Acronym
EMERGE
Status last verified
Aug 2021
First submitted
18 Jun 2015
Last updated
2 Sep 2021
Data monitoring committee
Yes

Publications

  • Atri A, Curiale GG, Aisen P, Barakos J, Purcell D, Bracoud L, Haeberlein SB, Grassi C, Hughes R, Smirnakis K. Spectrum of amyloid-related imaging abnormalities associated with aducanumab treatment: a case series report. BMC Neurol. 2026 Jul 30;26(1):671. doi: 10.1186/s12883-026-05097-9.

    PubMed 42934592

  • Pang M, Brothers HM, O'Gorman J, Murphy J, Zabar Y, Lasky T, Shen C, Rubino I, Knopman D. Longitudinal clinical outcomes after amyloid clearance in aducanumab phase 3 studies. Alzheimers Dement. 2026 Oct;22(10):e71758. doi: 10.1002/alz.71758.

    PubMed 42841310

  • Cummings J, Cohen S, Murphy J, Brothers HM, Nejati M, Forrestal F, de Moor C, O'Gorman J, Harrison J, Jaeger J, Mummery CJ, Porsteinsson AP, Potashman M, Tian Y, Yang L, He P, Haeberlein SB. Evaluation of cognitive, functional, and behavioral effects observed in EMERGE, a phase 3 trial of aducanumab in people with early Alzheimer's disease. Alzheimers Dement. 2025 Jun;21(6):e70224. doi: 10.1002/alz.70224.

    PubMed 40545559

  • Burton J, Brothers HM, Hutchison RM, Murphy J, Sun T, Dent G, Curiale G, Kowalski K. Lower baseline amyloid beta burden is associated with greater percent of amyloid beta positron emission tomography reduction and better clinical outcomes in the aducanumab Phase 3 trials ENGAGE and EMERGE in early Alzheimer's disease. J Prev Alzheimers Dis. 2025 Aug;12(7):100202. doi: 10.1016/j.tjpad.2025.100202. Epub 2025 May 24.

    PubMed 40413110

  • Loomis SJ, Miller R, Castrillo-Viguera C, Umans K, Cheng W, O'Gorman J, Hughes R, Budd Haeberlein S, Whelan CD. Genome-Wide Association Studies of ARIA From the Aducanumab Phase 3 ENGAGE and EMERGE Studies. Neurology. 2024 Feb 13;102(3):e207919. doi: 10.1212/WNL.0000000000207919. Epub 2023 Dec 28.

    PubMed 38165296

  • Muralidharan KK, Kowalski KG, Tong X, Haeberlein SB, Rajagovindan R, Nestorov I. Characterization of exposure-Clinical Dementia Rating-Sum of Boxes relationship in subjects with early Alzheimer's disease from the aducanumab Phase 3 trials. J Pharmacokinet Pharmacodyn. 2023 Feb;50(1):45-62. doi: 10.1007/s10928-022-09839-3. Epub 2023 Jan 4.

    PubMed 36600109

  • Salloway S, Chalkias S, Barkhof F, Burkett P, Barakos J, Purcell D, Suhy J, Forrestal F, Tian Y, Umans K, Wang G, Singhal P, Budd Haeberlein S, Smirnakis K. Amyloid-Related Imaging Abnormalities in 2 Phase 3 Studies Evaluating Aducanumab in Patients With Early Alzheimer Disease. JAMA Neurol. 2022 Jan 1;79(1):13-21. doi: 10.1001/jamaneurol.2021.4161.

    PubMed 34807243

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aducanumab (BIIB037) in people with Alzheimer's Disease, run by Biogen at 180 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 180 sites in United States, Japan, Germany, Poland, Canada and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score at Week 78 (time frame: Baseline, Week 78). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02484547, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in