AzTrials
AzTrials

Alzheimer's DiseasePhase 3ENVISIONNCT05310071

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

A Phase 3 study testing Aducanumab in people with Alzheimer's Disease, run by Biogen at 265 sites in 16 countries.

Terminated

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

Official record
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Trial summary

The primary objective of this study is to verify the clinical benefit of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score as compared with placebo in participants with early Alzheimer's disease. Read more about this study

Who is it for?
Ages 60 to 85 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
Aducanumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,027 participants
Where
265 sitesin 16 countries
Study dates
2 Jun 2022to 12 Aug 2024
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 60 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Have an MMSE score between 22 and 30 inclusive
  • Have a CDR memory score >0.5
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  • Have a Clinical Dementia Rating Scale Global Score (CDR-GS) of 0.5 or 1.0
  • 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)

Who cannot join

  • 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
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  • 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

Trial locations and contacts

265 sites in 16 countries.

265 sites in 16 countries

United States130 sites

  • Abington Neurological Associates, LTD

    Abington, Pennsylvania, 19001

  • Neurological Associates of Albany, PC

    Albany, New York, 12208

  • Neurology of Central Florida Research Center, LLC

    Altamonte Springs, Florida, 32714

  • Dent Neurologic Institute

    Amherst, New York, 14226

  • JEM Research Institute

    Atlantis, Florida, 33462

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • Senior Adult Specialty Research

    Austin, Texas, 78757

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Mountain Neurological Research Center

    Basalt, Colorado, 81621

  • McLean Hospital

    Belmont, Massachusetts, 02478

  • The Memory Clinic

    Bennington, Vermont, 05201

  • Neurology Offices of South Florida, PLLC

    Boca Raton, Florida, 33428

  • ECommunity Research, LLC

    Boca Raton, Florida, 33486

  • Brigham and Women's Hospital Department of Neurology

    Boston, Massachusetts, 02115-5804

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Nova Clinical Research, LLC

    Bradenton, Florida, 34209

  • Social Psychiatry Research Institute (SPRI)

    Brooklyn, New York, 11235

  • Headlands Research - Brownsville

    Brownsville, Texas, 78526

  • University of Virginia Health System

    Charlottesville, Virginia, 22903

  • Great Lakes Clinical Trials, LLC Ravenswood dba Flourish Research

    Chicago, Illinois, 60637

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Neurology Clinic, PC

    Cordova, Tennessee, 38018

  • JY Research Institute

    Cutler Bay, Florida, 45417

  • Kerwin Medical Center

    Dallas, Texas, 75231

  • UT Southwestern Medical Center

    Dallas, Texas, 75390-8896

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • Wayne State University - Detroit Medical Center

    Detroit, Michigan, 48201

  • Duke University

    Durham, North Carolina, 27710

  • Rhode Island Hospital

    East Providence, Rhode Island, 02915-2237

  • Rhode Island Mood & Memory Research Institute

    East Providence, Rhode Island, 02915

  • Sun Valley Behaivoral Med Center

    El Centro, California, 92243

  • Alexian Brothers Medical Center - Neuroscience Research Institute

    Elk Grove Village, Illinois, 60007

  • Yale University

    Fairfield, Connecticut, 06824

  • University of Kansas Medical Center Research Institute, Inc.

    Fairway, Kansas, 66205

  • Michigan Institute for Neurological Disorders

    Farmington Hills, Michigan, 48334

  • Health Initiatives Research

    Fayetteville, Arkansas, 72703

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida, 33912

  • University of North Texas Health Science Center

    Fort Worth, Texas, 76107

  • Neuropain Medical Center

    Fresno, California, 93710

  • Neurology Center of North Orange County

    Fullerton, California, 92835

  • Gilbert Neurology Partners, PLLC

    Gilbert, Arizona, 85297

  • Hattiesburg Clinic, PA

    Hattiesburg, Mississippi, 39401

  • Infinity Clinical Research, LLC

    Hollywood, Florida, 33024

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii, 96817

  • Baylor College Of Medicine

    Houston, Texas, 77030

  • The Methodist Hospital Research Institute

    Houston, Texas, 77030

  • Clinical Trial Network LLC

    Houston, Texas, 77074

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • Irvine Center for Clinical Research, Inc.

    Irvine, California, 92614

  • The Clinical Trial Center, LLC

    Jenkintown, Pennsylvania, 19046

  • Genesis Neuroscience Clinic

    Knoxville, Tennessee, 37909

  • Charter Research, LLC

    Lady Lake, Florida, 32159

  • ARS - Lake Oconee

    Lakeland, Florida, 33803

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Las Vegas, Nevada, 89106

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89113

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40506

  • Mary S. Easton Center for Alzheimer's Disease Research, UCLA

    Los Angeles, California, 90095

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53705

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • AMC Research, LLC

    Matthews, North Carolina, 28105

  • ActivMed Practices and Research

    Methuen, Massachusetts, 01844

  • Medical Research Center

    Miami, Florida, 33165

  • Medical College of Wisconsin, Inc.

    Milwaukee, Wisconsin, 53226

  • Institute for Neurodegenerative Disorders (IND)

    New Haven, Connecticut, 06510

  • Yale University School Of Medicine

    New Haven, Connecticut, 06511

  • Ochsner Health System PARENT

    New Orleans, Louisiana, 70121

  • New York University Medical Center PRIME

    New York, New York, 10016

  • Mount Sinai

    New York, New York, 10029

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

  • Boston Center for Memory

    Newton, Massachusetts, 02459

  • Glennan Center for Geriatrics and Gerontology

    Norfolk, Virginia, 23510

  • Neuro-Behavioral Clinical Research, Inc.

    North Canton, Ohio, 44720

  • Research Center for Clinical Studies, Inc.

    Norwalk, Connecticut, 06851

  • Renstar Medical Research

    Ocala, Florida, 34470

  • K2 Medical Research, LLC

    Ocoee, Florida, 34761

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-3285

  • K2 Medical Research, LLC

    Orlando, Florida, 32751

  • K2 Medical Research

    Orlando, Florida, 32751

  • Headlands Research LLC

    Orlando, Florida, 32819

  • Conquest Research

    Orlando, Florida, 32832

  • Sharlin Health and Neurology

    Ozark, Missouri, 65721

  • Stanford Hospital and Clinics

    Palo Alto, California, 94304

  • VA Palo Alto Health Care System

    Palo Alto, California, 94304

  • South Shore Neurologic Associates, P.C.

    Patchogue, New York, 11772

  • Penn Memory Center

    Philadelphia, Pennsylvania, 19104

  • Xenoscience Inc.

    Phoenix, Arizona, 85004

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • Donald S. Marks, M.D., P.C.

    Plymouth, Massachusetts, 02360

  • Quantum Laboratories Inc.

    Pompano Beach, Florida, 33064

  • United Medical Research

    Port Orange, Florida, 32127

  • Coastal Neurology PA

    Port Royal, South Carolina, 29935

  • Oregon Health & Science University (OHSU)

    Portland, Oregon, 97239

  • Butler Hospital

    Providence, Rhode Island, 02906

  • Anderson Clinical Research

    Redlands, California, 92374

  • National Clinical Research Inc. - Richmond

    Richmond, Virginia, 23294

  • Finger Lakes Clinical Research

    Rochester, New York, 14618

  • University of Rochester - PARENT

    Rochester, New York, 14642

  • Central Texas Neurology Consultants

    Round Rock, Texas, 78681

  • Center for Memory and Aging

    Saint Paul, Minnesota, 55130

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Sutter Health-San Francisco

    San Francisco, California, 94115

  • University of California San Francisco (PARENT)

    San Francisco, California, 94143

  • The Neuron Clinic

    San Marcos, California, 92069

  • Syrentis Clinical Research

    Santa Ana, California, 92705

  • HonorHealth Neurology

    Scottsdale, Arizona, 85251

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

  • University of Washington Medical Center

    Seattle, Washington, 98109

  • California Neuroscience Research, LLC

    Sherman Oaks, California, 91403

  • LSU Health Sciences Center Shreveport

    Shreveport, Louisiana, 71103

  • Kingfisher Cooperative, LLC

    Spokane, Washington, 99202

  • The Cognitive Research Center of New Jersey

    Springfield, New Jersey, 07081

  • Richmond Behavioral Associates ERG Clinical Research - New York PLLC

    Staten Island, New York, 10314

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

  • Brain Matters Research

    Stuart, Florida, 34997

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • K2 Medical Research Tampa

    Tampa, Florida, 33607

  • USF Health Byrd Institute

    Tampa, Florida, 33613

  • IMA Evaluations LLC

    Tarrytown, New York, 10591

  • Viking Clinical Research Center

    Temecula, California, 92591

  • CenExel Advanced Memory Research Institute of NJ

    Toms River, New Jersey, 08755

  • Banner Alzheimer's Institute

    Tucson, Arizona, 85012

  • Central States Research, LLC

    Tulsa, Oklahoma, 74136

  • Howard University Health Sciences

    Washington D.C., District of Columbia, 20060-0002

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

    Wichita, Kansas, 67214

  • Wake Forest Baptist Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

Japan19 sites

  • Tokushukai Shonan Atsugi Hospital

    Atsugi-shi, Kanagawa, 243-8551

  • Memory Clinic Ochanomizu

    Bunkyō City, Tokyo-To, 113-0034

  • Hakuyokai Kashiwado Hospital

    Chiba, Chiba, 260-8656

  • Inage Neurology and Memory Clinic

    Chiba, Chiba, 263-0043

  • Himeji Central Hospital Clinic

    Himeji-shi, Hyōgo, 672-8043

  • Tokushukai Shonan Kamakura General Hospital

    Kamakura-shi, Kanagawa, 247-8533

  • Midorikai Takesato Hospital

    Kasukabe-shi, Saitama, 344-0036

  • Teikyo University Hospital, Mizonokuchi

    Kawasaki-shi, Kanagawa, 213-8507

  • Tokushukai Kishiwada Tokushukai Hospital

    Kishiwada-shi, Osaka, 596-0042

  • Kagawa University Hospital

    Kita-gun, Kagawa-ken, 761-0793

  • National Center of Neurology and Psychiatry

    Kodaira-shi, Tokyo-To, 187-8551

  • Southern Tohoku Medical Clinic

    Koriyama-shi, Fukushima, 963-8563

  • Katayama Medical Clinic

    Kurashiki-shi, Okayama-ken, 710-0813

  • Rakuwakai Otowa Rehabilitation Hospital

    Kyoto, Kyoto, 607-8113

  • NHO Utano National Hospital

    Kyoto, Kyoto, 616-8255

  • National Center For Geriatrics And Gerontology

    Obu-shi, Aichi-ken, 474-8511

  • NHO Hiroshima-Nishi Medical Center

    Otake-shi, Hiroshima, 739-0696

  • Osaka University Hospital

    Suita-shi, Osaka, 565-0871

  • Tokushukai Yamagata Tokushukai Hospital

    Yamagata, Yamagata, 990-0834

Other trials in Japan

Germany18 sites

  • Zentrum für klinische Forschung Dr.med. Irma Schöll

    Bad Homburg, Hesse, 61350

  • Klinikum Bayreuth GmbH- Hohe Warte

    Bayreuth, Bavaria, 95445

  • NEUROZENTRUM tempelhof.berlin

    Berlin, 12099

  • Charité - Universitätsmedizin Berlin

    Berlin, 13125

  • Katholisches Klinikum Bochum gGmbH

    Bochum, North Rhine-Westphalia, 44791

  • Deutsches Zentrum fuer Neurodegenerative Erkrankungen (DZNE)

    Bonn, North Rhine-Westphalia, 53127

  • Universitaetsklinikum Koeln

    Cologne, North Rhine-Westphalia, 50937

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, Saxony, 1307

  • Universitaetsklinikum Duesseldorf AoeR

    Düsseldorf, North Rhine-Westphalia, 40225

  • Universitaetsklinikum Frankfurt Goethe-Universitaet

    Frankfurt am Main, Hesse, 60528

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Universitaetsmedizin Goettingen

    Göttingen, Lower Saxony, 37075

  • Universitaetsmedizin Greifswald

    Greifswald, Mecklenburg-Vorpommern, 17475

  • Universitaetsklinikum Magdeburg

    Magdeburg, Saxony-Anhalt, 39120

  • 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 Tuebingen

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Canada14 sites

  • University of Calgary - Heritage Medical Research Clinic

    Calgary, Alberta, T2N 4Z6

  • Clinique de la Memoire de l'Outaouais

    Gatineau, Quebec, J8T 8J1

  • MoCA Research and Innovation Inc

    Greenfield Park, Quebec, J4V 2J2

  • Centricity Research Halifax

    Halifax, Nova Scotia, B3S 1N2

  • Montreal Neurological Institute Clinical Research Unit

    Montreal, Quebec, H3A 2B4

  • Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic

    Ottawa, Ontario, K1Z 1G3

  • Kawartha Centre - Redefining Healthy Aging

    Peterborough, Ontario, K9H 2P4

  • CHU de Quebec- Hopital de l Enfant Jesus

    Québec, G1J1Z4

  • Toronto Memory Program (Neurology Research Inc.)

    Toronto, Ontario, M3B 2S7

  • Centricity Research Toronto LMC

    Toronto, Ontario, M4G 3E8

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

  • Baycrest Centre for Geriatric Care

    Toronto, Ontario, M6A 2E1

  • UBC Hospital

    Vancouver, British Columbia, V6T 2B5

Other trials in Canada

France12 sites

  • Groupe Hospitalier Pellegrin - Hôpital Pellegrin

    Bordeaux, Gironde, 33076

  • Hopital Roger Salengro - CHU Lille

    Lille, Nord, 59037

  • Hôpital de la Timone

    Marseille, Bouches-du-Rhône, 13385

  • Hopital Gui de Chauliac

    Montpellier, Herault, 34295

  • Hôpital Lariboisière

    Paris, Paris, 75010

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, 75013

  • Hôpital Broca

    Paris, 75013

  • CHU Rennes - Pontchaillou

    Rennes, Ille Et Vilaine, 35033

  • CHU Nantes - Hopital Nord Laënnec

    Saint-Herblain, Loire Atlantique, 44800

  • CHU Strasbourg - Hôpital Hautepierre

    Strasbourg, Bas Rhin, 67000

  • Hôpital La Grave

    Toulouse, Haute Garonne, 31059

  • Hôpital des Chapennes

    Villeurbanne, Rhone, 69100

Other trials in France

Italy12 sites

  • Ospedale di Arzignano

    Arzignano VI, Vicenza, 36071

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

    Brescia, 25123

  • Fondazione Istituto G.Giglio di Cefalù

    Cefalù, Palermo, 90015

  • IRCCS Ospedale Policlinico San Martino

    Genova, 16132

  • Ospedale San Raffaele

    Milan, 20132

  • ASST di Monza

    Monza, Milano, 20052

  • Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"

    Naples, 80138

  • Azienda Ospedaliera e Universitaria di Perugia

    Perugia, 6156

  • Fondazione Santa Lucia IRCCS

    Roma, 00179

  • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

    Roma, 00185

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

    Salerno, 84131

  • Azienda Ospedaliera Card. G. Panico

    Tricase, Lecce, 73039

Other trials in Italy

Spain11 sites

  • Fundacio ACE

    Barcelona, 08028

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Universitario Reina Sofia

    Córdoba, Córdoba, 14004

  • Policlinica Gipuzkoa

    Donostia / San Sebastian, Guipuzcoa, 20009

  • Hospital Universitari de Santa Maria

    Lleida, 25198

  • Clinica Universidad de Navarra (MAD)

    Madrid, 28027

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Hospital Victoria Eugenia

    Seville, 41009

  • Hospital Universitario Dr. Peset

    Valencia, 46017

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

United Kingdom11 sites

  • The RICE Centre

    Bath, Somerset, BA1 3NG

  • Re Cognition Health Bristol

    Bristol, BS32 4SY

  • The University of Edinburgh

    Edinburgh, East Lothian, EH8 9YL

  • Brain Health Scotland Life Sciences

    Edinburgh, Lothian Region, EH12 9DQ

  • Institute of Psychiatry, Psychology and Neuroscience

    London, Greater London, SE5 8AF

  • Re:Cognition Health Ltd (London)

    London, Greater London, W1G 9RU

  • Charing Cross Hospital

    London, Greater London, W6 8RF

  • Park House

    Manchester, Greater Manchester, MR8 5RB

  • Glasgow Memory Clinic Ltd

    Motherwell, Strathclyde, ML1 4UF

  • Southampton General Hospital

    Southampton, Hampshire, SO16 6YD

  • Moorgreen Hospital

    Southampton, Hampshire, SO30 3JB

Other trials in United Kingdom

Australia8 sites

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Frankston Hospital

    Frankston, Victoria, 3199

  • Austin Health

    Heidelberg, Victoria, 3084

  • KaRa Institute of Neurological Diseases

    Macquarie Park, New South Wales, 2113

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Australian Alzheimer's Research Foundation

    Nedlands, Western Australia, 6009

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

Other trials in Australia

Poland8 sites

  • Podlaskie Centrum Psychogeriatrii

    Bialystok, Podkarpackie Wojewódctwo, 15-756

  • PROMENTE Sp. z o.o.

    Bydgoszcz, Kujawsko-Pomorskie Województwo, 85-133

  • Nzoz Novo-Med

    Katowice, Śląskie Województwo, 40-650

  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Kliniczny Oddział Neurologii Oddział Udarowy

    Lublin, 20-090

  • Neuro-Care Gabriela Klodowska

    Siemianowice Śląskie, Śląskie Województwo, 41-100

  • Centrum Medyczne Senior

    Sopot, Pomorskie Województwo, 81-855

  • Centrum Medyczne NeuroProtect

    Warsaw, Mazowieckie Województwo, 01-684

  • NZOZ Wroclawskie Centrum Alzheimerowskie

    Wroclaw, 53659

Other trials in Poland

Brazil5 sites

  • Trial Tech Tecnologia em Pesquisas com Medicamentos Ltda

    Curitiba, Paraná, 80240-280

  • Instituto de Neurologia de Curitiba - Hospital Ecoville

    Curitiba, Paraná, 81210-310

  • IMV Pesquisa Neurologica Sociedade Simples Ltda

    Porto Alegre, Rio Grande do Sul, 90110-000

  • Instituto do Cerebro do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul, 90610-000

  • IPq-HCFMUSP - Instituto de Psiquiatria do Hospital das Clínicas da FMUSP

    São Paulo, São Paulo, 05403-010

Other trials in Brazil

Mexico5 sites

  • Hospital Mexico Americano SC

    Guadalara, Jalisco, 44610

  • Health Pharma Professional Research S.A. de C.V.

    Mexico City, Mexico City, 3103

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, Nuevo León, 64460

  • Centro de Estudios Clinicos y Especialidades Medicas, S.C.

    Monterrey, Nuevo León, 64620

  • AVIX Investigación Clínica S.C

    Monterrey, Nuevo León, 64710

Other trials in Mexico

Belgium4 sites

  • AZ Sint-Jan

    Bruges, 8000

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

  • AZ Groeninge

    Kortrijk, 8500

  • UZ Leuven

    Leuven, Flemish Brabant, 3000

Other trials in Belgium

South Korea3 sites

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Konkuk University Medical Center

    Seoul, 5030

  • Asan Medical Center

    Seoul, 5505

Other trials in South Korea

Sweden3 sites

  • Skane University Hospital

    Malmö, Skåne County, 205 02

  • Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus

    Mölndal, Västra Götaland County, 43180

  • Karolinska Universitetssjukhuset

    Stockholm, 14186

Other trials in Sweden

Finland2 sites

  • Terveystalo Ruoholahti

    Helsinki, 00100

  • CRST, Clinical Research Services Turku

    Turku, 20520

Other trials in Finland

About this study

Official title: 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

The primary objective of this study is to verify the clinical benefit of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score as compared with placebo in participants with early Alzheimer's disease.

Being tested
Aducanumab, Placebo
Medical subject headings
Alzheimer Disease

What participants receive

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

  • AducanumabDrug

    Also called BIIB037, Aducanumab-avwa, Aduhelm

    Administered as specified in the treatment arm.

  • PlaceboDrug

    Administered as specified in the treatment arm.

Study groups in NCT05310071
Study groupRoleWhat they receive
AducanumabExperimentalParticipants will receive aducanumab, up to 10 milligrams per kilogram (mg/kg), monthly (once every four weeks), administered as intravenous (IV) infusion.
Receives: Drug: Aducanumab
PlaceboPlacebo comparatorParticipants will receive placebo, monthly (once every four weeks), administered as IV infusion.
Receives: 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

    The Clinical Dementia Rate Scale integrates assessments from 3 domains of cognition (memory, orientation, judgment/problem-solving) and 3 domains of function (community affairs, home/hobbies, personal care). Following the caregiver interview and systematic participant examination, the rater assigns a score describing the participant's current performance level in each of these domains of life functioning. The "Sum of boxes" scoring methodology sums the score for each of the 6 domains and provides a value ranging from 0 to 18. Higher scores indicate greater impairment. A positive change from baseline indicates greater impairment.

    Measured: Baseline, Week 78

Secondary outcomes (9)

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

    The iADRS composite captures a decline in both cognition and daily function. It is a simple linear combination of the Alzheimer's disease assessment scale, cognitive subscale (ADAS-Cog13), and the Alzheimer's disease cooperative study scale for activities of daily living in mild cognitive impairment (ADCS-ADL-MCI). The ADAS-Cog13 scale ranges from 0 to 85 (higher scores indicate worse performance) and the ADCS-ADL-MCI scale ranges from 0 to 53 (higher scores indicate greater independent, healthy functioning). The total score for iADRS scale ranges from 0 to 138, where higher scores indicate better performance.

    Measured: Baseline, Weeks 78 and 106

  2. 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

    The ADCS-ADL-MCI scale consists of 17 instrumental items (e.g., shopping, preparing meals, using household appliances, etc) and 1 basic item (getting dressed). Ratings reflect caregiver observations about the participant'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. Higher scores indicate greater independent, healthy functioning. A positive change from baseline indicates healthy functioning while a negative change from baseline indicates a decline in independent functioning.

    Measured: Baseline, Weeks 78 and 106

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

    ADAS-Cog13 comprises both cognitive tasks and clinical ratings of cognitive performance. The cognitive subscale 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. Higher scores indicate worse performance. A positive change from baseline indicates decline in cognitive performance.

    Measured: Baseline, Weeks 78 and 106

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

    The MMSE scale is a 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. Higher scores indicate better performance. A negative change from baseline indicates decline in cognitive performance.

    Measured: Baseline, Weeks 78 and 106

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

    The NPI-10 is a questionnaire administered to the informant, designed to obtain information on the presence of neuropsychiatric symptoms and behaviors in a participant with Alzheimer's disease. Ten areas are assessed: delusions, hallucinations, agitation/aggression, depression, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability and aberrant motor behavior. The NPI total score ranges from 0 to 120. Higher scores indicate greater impairment. A negative change from baseline indicates improvement (symptom reduction).

    Measured: Baseline, Weeks 78 and 106

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

    Amyloid PET scan assesses cerebral amyloid load using radiotracers which is standardized into centiloids. Centiloid values on centiloid scale is based on mean composite standardized uptake value ratio (SUVR).

    Measured: Baseline, Weeks 78 and 104

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

    The cerebral tau level was measured by tau PET imaging. Tau PET imaging was conducted using radiotracer. SUVR is a ratio of PET uptake measured in brain region of interest and a disease-free reference region. A higher SUVR is an indication of increased PET radiotracer uptake and worsening disease.

    Measured: Baseline, Weeks 78 and 104

  8. Change From Baseline in CDR-SB Score at Week 106

    The CDR 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 participant examination, the rater assigns a score describing the participant's current performance level in each of these domains of life functioning. The CDR-SB sums the score for each of the 6 domains and provides a value ranging from 0 to 18. Higher scores indicate greater impairment. Positive change from baseline indicates greater impairment.

    Measured: Baseline, Week 106

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

    GST z-score is an average of z-scores of CDR-SB, ADASCog13 and ADCS-ADL-MCI. CDR-SB assesses 3 cognitive (memory,orientation, judgment/problem-solving)and 3 functional(community affairs,home/hobbies,personal care) domains. Sum of Boxes method combines scores across 6 domains, ranging from 0-18(higher scores=greater impairment). ADAS-Cog13 evaluates cognitive tasks like word recall, naming, orientation and memory, with scores from 0-85 (higher scores=worse performance). ADCS-ADL-MCI rates 17 tasks (e.g.,shopping, preparing meal) and 1 basic task(dressing) with scores from 0-53 (higher scores=greater independence/healthy functioning). z-score>0 indicates greater impairment/worse performance for CDR-SB and ADASCog13 scales and improved functioning for ADCS-ADL-MCI. For ADCS-ADL-MCI, z-score were reversed (new reversed value=original value-1) to make interpretation consistent. The GST z-score of 0 indicates population mean and score>0 indicate greater impairment/worse performance.

    Measured: Baseline, Weeks 78 and 106

Timeline

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

  1. First posted4 Apr 2022
  2. Study start2 Jun 2022
  3. Primary completion12 Aug 2024
  4. Study completion12 Aug 2024

Why it stopped: Sponsor's Decision

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
1,027 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05310071
Sponsor's protocol ID
221AD305
Other IDs
2022-001671-14
Acronym
ENVISION
Status last verified
Apr 2025
First submitted
25 Mar 2022
Last updated
23 Apr 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aducanumab in people with Alzheimer's Disease, run by Biogen at 265 sites in 16 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 10 inclusion and 11 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 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 265 sites in United States, Japan, Germany, Canada, France and 11 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. Some participants in this study may receive a placebo. 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 23 Apr 2025). 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 NCT05310071.

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 23 Apr 2025.

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