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Alzheimer's DiseasePhase 3ENGAGENCT02477800

221AD301 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 181 sites in 14 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
1,653 participants
Where
181 sitesin 14 countries
Study dates
13 Aug 2015to 8 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

181 sites in 14 countries.

181 sites in 14 countries

United States59 sites

  • Albany Medical College

    Albany, New York, 12208

  • Brigham & Women's Hosp End/Dbt

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

  • ANI Neurology, PLLC d/b/a Alzheimer's Memory Center

    Charlotte, North Carolina, 28270

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Neurology Clinic, PC

    Cordova, Tennessee, 38108

  • UT Southwestern Medical Center at Dallas

    Dallas, Texas, 75390

  • Brain Matters Research, Inc.

    Delray Beach, Florida, 33445

  • Rhode Island Mood & Memory Research Institute

    East Providence, Rhode Island, 02915

  • Alexian Brothers Neurosciences Institute

    Elk Grove Village, Illinois, 60007

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida, 33912

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana, 46804

  • Neurology Center of North Orange County

    Fullerton, California, 92835

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • The Clinical Trial Center, LLC

    Jenkintown, Pennsylvania, 19046

  • University of Kansas Medical Center Research Institute, Inc.

    Kansas City, Kansas, 66160

  • University of Tennessee Medical Center. Knoxville

    Knoxville, Tennessee, 37920

  • Senior Clinical Trials, Inc.

    Laguna Hills, California, 92653

  • Las Vegas Medical research

    Las Vegas, Nevada, 89113

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Torrance Clinical Research Institute, Inc.

    Lomita, California, 90717

  • University of California - Los Angeles

    Los Angeles, California, 90095

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee, 38119

  • ActivMed Practices & Research

    Methuen, Massachusetts, 01844

  • University of Miami

    Miami, Florida, 33136

  • Miami Jewish Health Systems

    Miami, Florida, 33137

  • Medical College of Wisconsin, Inc.

    Milwaukee, Wisconsin, 53266

  • Institute for Neurodegenerative Disorders

    New Haven, Connecticut, 06510

  • New York University Medical Center PRIME

    New York, New York, 10016

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Compass Research Main

    Orlando, Florida, 32806

  • Palm Beach Neurological Center

    Palm Beach Gardens, Florida, 33410

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Northeastern Pennsylvania Memory and Alzheimer's Center

    Plains, Pennsylvania, 18705

  • Donald S. Marks, M.D., P.C.

    Plymouth, Massachusetts, 02360

  • Butler Hospital

    Providence, Rhode Island, 02906

  • Raleigh Neurology Associates, P.A.

    Raleigh, North Carolina, 27607-6010

  • National Clinical Research Inc.-Richmond

    Richmond, Virginia, 23294

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14620

  • UCSF - Memory and Aging Center

    San Francisco, California, 94158

  • California Neuroscience Research Medical Group Inc.

    Sherman Oaks, California, 91403

  • Southern California Research LLC

    Simi Valley, California, 93065

  • Washington University

    St Louis, Missouri, 63131

  • Stedman Clinical Trials, LLC

    Tampa, Florida, 33613

  • USF Health Byrd Institute

    Tampa, Florida, 33616

  • Meridien Research

    Tampa, Florida, 33634

  • Compass Research Main

    The Villages, Florida, 32162

  • Advanced Memory Research Institute of NJ, PC

    Toms River, New Jersey, 08755

  • Center for Neurosciences

    Tucson, Arizona, 85718

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20057

  • Premiere Research Institute

    West Palm Beach, Florida, 33407

  • Cleveland Clinic Florida - Weston

    Weston, Florida, 33331

  • Via Christi Research, a division of Via Christi Hospitals Wichita, Inc.

    Wichita, Kansas, 67214

Other trials in United States

Japan26 sites

  • Research Site

    Aizuwakamatsu-shi, Fukushima, 965-8585

  • Research Site

    Asahikawa-shi, Hokkaido, 070-8644

  • Research Site

    Atsugi-shi, Kanagawa, 243-8551

  • Research Site

    Bunkyō City, Tokyo-To, 113-0034

  • Research Site

    Chiba, Chiba, 263-0043

  • Research Site

    Inzai-shi, Chiba

  • Research Site

    Iruma-gun, Saitama, 350-0495

  • Research Site

    Kamakura-shi, Kanagawa, 247-8533

  • Research Site

    Kasukabe-shi, Saitama, 344-0036

  • Research Site

    Kawasaki-Shi, Kanagawa, 211-8533

  • Research Site

    Kiyose-shi

  • Research Site

    Kodaira-shi, 187-8551

  • Research Site

    Kurume-shi, Fukuoka, 830-0011

  • Research Site

    Kyoto, Kyoto, 616-8255

  • Research Site

    Nagaoka-shi, Niigata, 940-2081

  • Research Site

    Ōta-ku, Tokyo, 143-8541

  • Research Site

    Sapporo, Hokkaido, 006-8555

  • Research Site

    Sapporo, Hokkaido, 064-8570

  • Research Site

    Shinjuku-ku, Tokyo-To, 162-8655

  • Research Site

    Shinjuku-ku (I), Tokyo-To, 162-8655

  • Research Site

    tabashi City, 173-0015

  • Research Site

    tabashi City, 173-8610

  • Research Site

    Yamagata, Yamagata, 990-0834

  • Study site

    Yokohama, Kanagawa, 223-0059

  • Research Site

    Yokohama, Kanagawa, 225-0013

  • Research Site

    Yokohama, Kanagawa, 225-0025

Other trials in Japan

Italy13 sites

  • Azienda Ospedaliera Ospedali Riuniti di Bergamo

    Bergamo, 24100

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, 25100

  • Fondazione Istituto G.Giglio di Cefalù

    Cefalù, Palermo, 90015

  • Azienda Ospedaliero Universitaria San Martino

    Genova, 16132

  • Ospedale San Raffaele

    Milan, 20132

  • Casa di Cura del Policlinico

    Milan, 20144

  • Azienda Ospedaliera Universitaria "Federico II"

    Naples, 80131

  • Seconda Università degli Studi di Napoli

    Naples, 80138

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168

  • Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona

    Salerno, 84131

  • A.O.U. Senese Policlinico Santa Maria alle Scotte

    Siena, 53100

  • Azienda Ospedaliero Universitaria Ospedali Riuniti

    Torrette Di Ancona, Ancona, 60126

Other trials in Italy

United Kingdom13 sites

  • The RICE Centre

    Bath, Somerset, BA1 3NG

  • Manchester Royal Infirmary

    Blackburn, Merseyside, BB3 2HH

  • Southmead Hospital

    Bristol, Avon, BS16 1LE

  • Kingshill Research Centre

    Chippenham, Wiltshire, SN15 1GG

  • Ninewells Hospital

    Dundee, Tayside Region, DD2 1GZ

  • The University of Edinburgh

    Edinburgh, Lothian Region, EH8 9YL

  • Glasgow Memory Clinic Ltd

    Glasgow, Strathclyde, G20 0XA

  • Stobhill ACH Hospital

    Glasgow, Strathclyde, G21 3UW

  • Re:Cognition Health Ltd

    London, Greater London, W1G 9JF

  • Charing Cross Hospital

    London, Greater London, W6 8RF

  • The National Hospital for Neurology and Neurosurgery Centre

    London, Greater London, WC1N 3BG

  • Newcastle University

    Newcastle upon Tyne, Tyne & Wear, NE4 5PL

  • Salford Royal

    Salford, Greater Manchester, M6 8HD

Other trials in United Kingdom

Australia12 sites

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • The Prince Charles Hospital

    Chermside, Queensland, 4032

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Central Coast Neurosciences Research, Gosford

    East Gosford, New South Wales, 2250

  • Central Coast Neurosciences Research

    Erina, New South Wales, 2250

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4006

  • KARA Institute for Neurological Diseases

    North Ryde, New South Wales, 2113

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Toowoomba Base Hospital

    Toowoomba, Queensland, 4350

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

  • Neurodegenerative Disorders Research

    West Perth, Western Australia, 6005

Other trials in Australia

Germany11 sites

  • Universitaetsklinikum Aachen AOeR

    Aachen, North Rhine-Westphalia, 52074

  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berlin, 14050

  • Praxis Dr. Scholz

    Böblingen, Baden-Wurttemberg, 71034

  • Universitaetsklinikum Bonn AoeR

    Bonn, North Rhine-Westphalia, 53127

  • Universitaetsklinikum Koeln

    Cologne, North Rhine-Westphalia, 53105

  • Klinikum der Johann Wolfgang Goethe-Universitaet

    Frankfurt, Bavaria, 97080

  • Klinische Forschung Hannover-Mitte GmbH

    Hanover, Lower Saxony, 30159

  • Neurologische Gemeinschaftspraxis Kassel

    Kassel, Hesse, 34121

  • Praxis Dr. med. Bergmann

    Neuburg am Inn, Bavaria, 86633

  • Aerztliche Gemeinschaftspraxis

    Ostfildern, Baden-Wurttemberg, 73760

  • Neuro MVZ Stuttgart

    Stuttgart, Baden-Wurttemberg, 70182

Other trials in Germany

Canada8 sites

  • Heritage Medical Research Clinic

    Calgary, Alberta, T2N 1N4

  • The Montreal Neurological Institute

    Montreal, Quebec, H3A 2B4

  • The Medical Arts Health Research Group

    Penticton, British Columbia, V2A 5C8

  • CHU de Quebec - Hôpital de l' Enfant Jésus

    Québec, G1J 1Z4

  • Toronto Memory Program (Neurology Research Inc.)

    Toronto, Ontario, M3B 2S7

  • Toronto Sunnybrook Hospital

    Toronto, Ontario, M4N 3M5

  • UBC Hospital

    Vancouver, British Columbia, V6T 2B5

  • McGill Centre for Studies in Aging

    Verdun, Quebec, H4H 1R3

Other trials in Canada

Spain8 sites

  • Hospital de Cruces

    Barakaldo, Vizcaya, 48903

  • Fundacio ACE

    Barcelona, 08028

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Policlinica Guipuzcoa

    Donostia / San Sebastian, Guipuzcoa, 20014

  • Clinica Ruber

    Madrid, 28006

  • Hospital Universitario Dr. Peset

    Valencia, 46017

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

France7 sites

  • Groupe Hospitalier Pellegrin - Hôpital Pellegrin

    Bordeaux, Gironde, 33076

  • Hopital Neurologique Pierre Wertheimer

    Bron, Rhone, 69677

  • Groupe hospitalier Broca - La Rochefoucauld - La Collégiale

    Paris, 75013

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, 75013

  • CHU Reims - Hôpital Maison Blanche

    Reims, Marne, 51092

  • Hopital Louis Pasteur Colmar

    Strasbourg, Bas Rhin, 67091

  • CHU Strasbourg - Hôpital Hautepierre

    Strasbourg, Bas Rhin, 67098

Other trials in France

Portugal6 sites

  • Hospital Professor Doutor Fernando Fonseca, E.P.E.

    Amadora, 2720-276

  • Hospital de Braga

    Braga, 4710-243

  • Centro Hospitalar e Universitário de Coimbra E.P.E

    Coimbra, 3040-278

  • CUF Alvalade

    Lisbon, 1600-618

  • Hospital Beatriz Ângelo

    Loures, 2674-514

  • Campus Neurologico Senior

    Torres Vedras, 2560-280

Other trials in Portugal

South Korea6 sites

  • Inha University Hospital

    Incheon, Gyeonggi-do, 22332

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Konkuk University Medical Center

    Seoul, 143-729

Other trials in South Korea

Taiwan6 sites

  • Changhua Christian Hospital

    Changhua, 500

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan County, 333

Other trials in Taiwan

Denmark4 sites

  • CCBR - Ålborg - DK

    Aalborg, 9100

  • CCBR - Ballerup - DK

    Ballerup Municipality, 2750

  • Rigshospitalet

    København Ø, 2100

  • CCBR - Vejle - DK

    Vejle, 7100

Other trials in Denmark

Austria2 sites

  • LKH - Universitaetsklinikum Graz

    Graz, 8036

  • Christian-Doppler-Klinik - Universitätsklinikum Salzburg

    Salzburg, 5020

Other trials in Austria

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
BIIB037, Aducanumab
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 NCT02477800
Study groupRoleWhat they receive
Low DoseExperimentalMonthly intravenous (IV) infusion
Receives: Drug: Aducanumab (BIIB037); Drug: Placebo
High DoseExperimentalMonthly intravenous (IV) infusion
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 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) Score 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 posted23 Jun 2015 (estimated)
  2. Study start13 Aug 2015
  3. Primary completion8 Aug 2019
  4. Study completion8 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
1,653 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02477800
Sponsor's protocol ID
221AD301
Other IDs
2015-000966-72, 2015
Acronym
ENGAGE
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

  • 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 181 sites in 14 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 181 sites in United States, Japan, Italy, United Kingdom, Australia and 9 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 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 NCT02477800, which also lists 5 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.

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