AzTrials
AzTrials

Alzheimer's DiseasePhase 3CREAD 2NCT03114657

A Study of Crenezumab Versus Placebo to Evaluate the Efficacy and Safety in Participants With Prodromal to Mild Alzheimer's Disease (AD)

A Phase 3 study testing Crenezumab in people with Alzheimer's Disease, run by Hoffmann-La Roche at 211 sites in 27 countries.

Terminated

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

Official record
Search all trials

Trial summary

This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild 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?
Crenezumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
806 participants
Where
211 sitesin 27 countries
Study dates
29 Mar 2017to 11 Jun 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

  • Weight between 40 and 120 kilograms (Kg) inclusive
  • Availability of a person (referred to as the "caregiver") who in the investigator's judgment:
  • Has frequent and sufficient contact with the participant to be able to provide accurate information regarding the participant's cognitive and functional abilities, agrees to provide information at clinic visits (which require partner input for scale completion), signs the necessary consent form, and has sufficient cognitive capacity to accurately report upon the participant's behavior and cognitive and functional abilities
  • Fluency in the language of the tests used at the study site
  • Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted)
  • Evidence of the AD pathological process, by a positive amyloid assessment either on cerebrospinal fluid (CSF) amyloid beta 1-42 levels as measured on the Elecsys beta-amyloid(1-42) test system or amyloid PET scan by qualitative read by the core/central PET laboratory
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  • Demonstrated abnormal memory function at screening (up to 4 weeks before screening begins) or screening (FCSRT cueing index =<0.67 AND free recall =<27)
  • Screening mini mental state examination (MMSE) score of greater than or equal to (>=) 22 points and Clinical Dementia Rating-Global Score (CDR-GS) of 0.5 or 1.0
  • Meets National Institute on Aging/Alzheimer's Association (NIAAA) core clinical criteria for probable AD dementia or prodromal AD (consistent with the NIAAA diagnostic criteria and guidelines for mild cognitive impairment (MCI)
  • If receiving symptomatic AD medications, the dosing regimen must have been stable for 3 months prior to screening
  • Participant must have completed at least 6 years of formal education after the age of 5 years

Who cannot join

  • Any evidence of a condition other than AD that may affect cognition such as other dementias, stroke, brain damage, autoimmune disorders (e.g. multiple sclerosis) or infections with neurological sequelae.
  • History of major psychiatric illness such as schizophrenia or major depression (if not considered in remission)
  • At risk of suicide in the opinion of the investigator
  • Any abnormal MRI findings, such as presence of cerebral vascular pathology, cortical stroke, etc or inability to tolerate MRI procedures or contraindication to MRI
  • Unstable or clinically significant cardiovascular (e.g., myocardial infarction), kidney or liver disease
  • Uncontrolled hypertension
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  • Screening hemoglobin A1c (HbA1C) >8%
  • Poor peripheral venous access
  • History of cancer except:
  • If considered to be cured or If not being actively treated with anti-cancer therapy or radiotherapy
  • Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins

Trial locations and contacts

211 sites in 27 countries.

211 sites in 27 countries

United States48 sites

  • JEM Research LLC

    Atlantis, Florida, 33462

  • Senior Adults Specialty Research

    Austin, Texas, 78757

  • Gadolin Research, LLC

    Beaumont, Texas, 77702

  • Bradenton Research Center

    Bradenton, Florida, 34205

  • Behavioral Health Research

    Charlotte, North Carolina, 28211

  • University of Cincinnati; Department of Psychiatry and Behavioral Neuroscience

    Cincinnati, Ohio, 45219

  • MCB Clinical Research Centers

    Colorado Springs, Colorado, 80910

  • Columbus Memory Center

    Columbus, Georgia, 31909

  • Ohio State University; College of Medicine

    Columbus, Ohio, 43210

  • Neurology Clinic PC

    Cordova, Tennessee, 38018

  • Texas Neurology PA

    Dallas, Texas, 75214

  • Kerwin Research Center, LLC

    Dallas, Texas, 75231

  • Dayton Center for Neuro Disorders

    Dayton, Ohio, 45459

  • Health Initiatives Research, PLLC

    Fayetteville, Arkansas, 72703

  • Precise Research Centers

    Flowood, Mississippi, 39232

  • Neuropsychiatric Research; Center of Southwest Florida

    Fort Myers, Florida, 33912

  • Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine

    Houston, Texas, 77030

  • Lake Charles Clinical Trials, LLC

    Lake Charles, Louisiana, 70601

  • Alzheimer's Research and Treatment Center

    Lake Worth, Florida, 33414

  • Cleveland Clinic Lou Ruvo; Center for Brain Research

    Las Vegas, Nevada, 89106

  • Clinical Trials Inc.

    Little Rock, Arkansas, 72205

  • Columbia University Medical Center

    New York, New York, 10032

  • Sentara Medical Group

    Norfolk, Virginia, 23507

  • Research Center for Clinical Studies, Inc.

    Norwalk, Connecticut, 06851

  • Renstar Medical Research

    Ocala, Florida, 34470

  • University of Nebraska Medical Center; Dept of Neurological Sciences

    Omaha, Nebraska, 68198-8440

  • Bioclinica Research

    Orlando, Florida, 32806

  • Neuro-Therapeutics Inc.

    Pasadena, California, 91105

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Northeastern Pennsylvania Memory

    Plains, Pennsylvania, 18705

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Summit Research Network Inc.

    Portland, Oregon, 97210

  • Wake Research Associates

    Raleigh, North Carolina, 27612

  • Desert Valley Medical Group

    Rancho Mirage, California, 92270

  • Anderson Clinical Research, Inc.

    Redlands, California, 92374

  • National Clinical Research Inc.-Richmond

    Richmond, Virginia, 23294

  • University of California, Davis; Alzheimers Disease Center, Department of Neurology

    Sacramento, California, 95817

  • Health Partners Institute for Education and Research

    Saint Paul, Minnesota, 55130

  • Clinical Trials of Texas, Inc

    San Antonio, Texas, 78229

  • UCSF - Memory and Aging Center

    San Francisco, California, 94158

  • Imaging End Points Clinical Research

    Scottsdale, Arizona, 85258

  • KI Health Partners, LLC; New England Institute for Clinical Research

    Stamford, Connecticut, 06905

  • The Cognitive and Research Center of New Jersey

    Summit, New Jersey, 07081

  • Advanced Memory Research Institute of NJ

    Toms River, New Jersey, 08755

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20057

  • Burke Rehabilitation Hospital

    White Plains, New York, 10605

  • Abington Neurological Associates

    Willow Grove, Pennsylvania, 19090

  • Alzheimers Disease Center; Neurology

    Winchester, Massachusetts, 01890

Other trials in United States

Japan22 sites

  • National Center for Geriatrics and Gerontology

    Aichi, 474-8511

  • Inage Neurology and Memory Clinic

    Chiba, 263-0043

  • Fukuoka Mirai Hospital

    Fukuoka, 813-0017

  • National Hospital Organization Hiroshima-Nishi Medical Center

    Hiroshima, 739-0696

  • Tsukazaki Hospital

    Hyōgo, 671-1227

  • Kagawa Prefectural Central Hospital

    Kagawa, 760-8557

  • Fujisawa City Hospital

    Kanagawa, 251-8550

  • National Hospital Organization Sagamihara National Hospital

    Kanagawa, 252-0392

  • Ijinkai Takeda General Hospital

    Kyoto, 601-1495

  • Rakuwakai Otowarehabilitation Hospital

    Kyoto, 607-8113

  • National Hospital Organization Matsumoto Medical Center

    Nagano, 399-8701

  • Iwate Medical University Hospital

    Numakunai, 028-3695

  • Katayama Medical Clinic

    Okayama, 710-0813

  • Osaka University Hospital

    Osaka, 565-0871

  • Asakayama General Hospital

    Osaka, 590-0018

  • NHO Shizuoka Institute of Epilepsy and Neurological Disorders

    Shizuoka, 420-8688

  • Kanto Central Hospital

    Tokyo, 158-8531

  • Tokyo Medical University Hospital

    Tokyo, 160-0023

  • Shinjuku Research Park Clinic

    Tokyo, 169-0073

  • Tokyo Metropolitan Geriatric Hospital

    Tokyo, 173-0015

  • National Center of Neurology and Psychiatry

    Tokyo, 187-8551

  • Tokyo Medical University Hachioji Medical Center

    Tokyo, 193-0998

Other trials in Japan

Spain21 sites

  • Hospital Perpetuo Socorro, Servicio de Geriatria

    Albacete, 2006

  • CAE Oroitu

    Barakaldo, Vizcaya, 48903

  • Fundació ACE

    BArcelon, Barcelona, 08034

  • Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia

    Barcelona, 08025

  • Hospital Universitario de Burgos. Servicio de Neurología

    Burgos, 09006

  • Hospital la Magdalena; Servicio de Neurologia

    Castellon, Castellon, 12004

  • Hospital Universitario Reina Sofia; Servicio de Neurologia

    Córdoba, 14011

  • Policlínica Guipuzkoa; Servicio de Neurología

    Donosti-San Sebastián, Guipuzcoa, 20014

  • Hospital General Universitario de Elche; Servicio de Neurología

    Elche, Alicante, 03203

  • Hospital San Pedro; Servicio de Neurología

    Logroño, La Rioja, 26006

  • Hospital Ramon y Cajal; Servicio de Neurologia

    Madrid, 28034

  • Clinica Universitaria de Navarra; Servicio de Neurología

    Pamplona, Navarre, 31008

  • Hospital Virgen del Puerto. Servicio de Neurología

    Plasencia, Caceres, 10600

  • Hospital Quiron de Madrid; Servicio de Neurologia

    Pozuelo de Alarcón, Madrid, 28223

  • Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría; CSM La Alamedilla

    Salamanca, 37005

  • Hospital Santa Caterina, Unitat de Valoració de la memoria i les demencies

    Salt, Girona, 17090

  • Hospital General De Catalunya; Servicio de Neurologia

    Sant Cugat del Vallès, Barcelona, 8195

  • Hospital Universitario Marques de Valdecilla; Servicio de Neurología

    Santander, Cantabria

  • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Neurologia

    Santiago de Compostela, LA Coruña, 15706

  • Hospital Universitario Virgen Macarena; Servicio de Neurologia

    Seville, 41009

  • Hospital Mutua De Terrasa; Servicio de Neurologia

    Terrassa, Barcelona, 08222

Other trials in Spain

Canada12 sites

  • Clinique Neuro Rive-Sud

    Greenfield Park, Quebec, J4V 2J2

  • True North Clinical Research-Halifax

    Halifax, Nova Scotia, B3S 1M7

  • OCT Research ULC

    Kelowna, British Columbia, V1Y 1Z9

  • True North Clinical Research Kentville

    Kentville, Nova Scotia, B4N 5E3

  • Providence Care; Mental Health Services

    Kingston, Ontario, K7L 4X3

  • Parkwood Hospital; Geriatric Medicine

    London, Ontario, N6C 5J1

  • Kawartha Centre - Redefining Healthy Aging

    Peterborough, Ontario, K9H 2P4

  • ALPHA Recherche Clinique

    Québec, G3K 2P8

  • The Centre for Memory and Aging

    Toronto, Ontario, M4G 3E8

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1N9

  • Vancouver Island Health Authority

    Victoria, British Columbia, V8R 1J8

  • Devonshire Clinical Research Inc.

    Woodstock, Ontario, N4S 5P5

Other trials in Canada

Italy12 sites

  • IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer

    Brescia, Lombardy, 25125

  • Irccs Multimedica Santa Maria; Unita' Di Neurologia

    Castellanza, Lombardy, 21053

  • IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria

    Milan, Lombardy, 20132

  • Fondazione IRCCS Istituto Nazionale Neurologico Besta; UO Neuropatologia

    Milan, Lombardy, 20133

  • Ospedale S. Maria Nascente; Fondazione Don Gnocchi; Dip. Neurologia Riabilitativa

    Milan, Lombardy, 20148

  • Ospedale Casati Passirana di Rho; Centro Regionale Alzheimer

    Passirana, Lombardy, 20017

  • A.O. Universitaria Pisana; Neurologia

    Pisa, Tuscany, 56126

  • IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA

    Pozzilli, Molise, 86077

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata; Neurologia

    Rome, Lazio, 00133

  • Umberto I Policlinico di Roma-Università di Roma La Sapienza

    Rome, Lazio, 00185

  • Ospedale San Giovanni Calibita Fatebenefratell;Neurologia

    Rome, Lazio, 00186

  • AO Città della Salute e della Scienza Osp.S.Giov.Battista Molinette; SC Geriatria

    Turin, Piedmont, 10126

Other trials in Italy

France11 sites

  • Hopital Pellegrin; Cmrr Aquitaine

    Bordeaux, 33076

  • Hôpital de Jour du Centre pour Personnes Âgées; Louis Pasteur Neurologie

    Colmar, 68000

  • Hopital Roger Salengro; Service de Neurologie

    Lille

  • CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique

    Limoges, 87042

  • Hopital Broca

    Paris, 75013

  • CH Pitie Salpetriere; IM2A

    Paris, 75651

  • Hôpital Maison Blanche

    Reims, 51092

  • CHU Rennes - Hopital Pontchaillou

    Rennes, 35033

  • CHU de Rouen Hopital; Service de Neurologie

    Rouen, 76031

  • Hop Guillaume Et Rene Laennec; Cmrr St Herblain

    Saint-Herblain, 44800

  • Hopital des Charpennes

    Villeurbanne, 69100

Other trials in France

United Kingdom11 sites

  • The Fritchie Centre, Charlton Lane Centre, Charlon Lane, Leckhampton; The Fritchie Centre

    Cheltenham, GL53 9DZ

  • Surrey and Borders NHS Foundation Trust; Brain Science Research Unit

    Chertsey, KT16 0AE

  • Sussex Partnership NHS Foundation Trust; Cognitive Treatment and Research unit

    Crowborough, TN6 1HB

  • Ninewells Hospital

    Dundee, DD12 9SY

  • NHS Lothian - Western General Hospital; NHS Lothian - Western General Hospital

    Edinburgh, EH4 2XU

  • Queen Elizabeth University Hospital; Clinical Research Facility

    Glasgow, G51 4TF

  • RE:Cognition Health

    London, W1G 9RU

  • Charing Cross Hospital; Imperial Memory Unit, Level 10 West

    London, W6 8RF

  • Manchester Royal Infirmary

    Manchester, M13 9WL

  • John Radcliffe Hospital

    Oxford, OX3 9DU

  • University Southampton NHS Foundation Trust; Wessex Neurologica Centre

    Southampton, SO166YD

Other trials in United Kingdom

South Korea9 sites

  • Dong-A University Hospital

    Busan, 49201

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605

  • Seoul National University Hospital

    Seoul, 03080

  • Hanyang University Seoul Hospital

    Seoul, 04763

  • Konkuk University Medical Center

    Seoul, 05030

  • Samsung Medical Center

    Seoul, 06351

  • Seoul St Mary's Hospital

    Seoul, 06591

  • Borame Medical Center

    Seoul, 07061

Other trials in South Korea

Russia8 sites

  • State Autonomous Healthcare Institution "Republican Clinical Neurological Center

    Kazan', 420021

  • State autonomous institution of healthcare Inter-regional clinical and diagnostic center

    Kazan', 420101

  • Institution of RAMS (Mental Health Research Center of RAMS)

    Moscow, 115522

  • City Clinical Psychiatry Hospital #1

    Nizhny Novgorod, 603155

  • LLC Baltic Medicine

    Saint Petersburg, Sankt-Peterburg, 194356

  • St Nicolas Psychiatric Hospital; Chair of Psychiatry and Narcology of St. Petersburg Medical Academy

    Saint Petersburg, 190121

  • Nebbiolo Center for Clinical Trials

    Tomsk, 634009

  • State Healthcare Institution of Sverdlovsk Region Sverdlovsk Regional Clinical Psychiatric Hospita

    Yekaterinburg, Sverdlovsk Oblast, 620030

Other trials in Russia

Germany7 sites

  • ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic

    Berlin, 13125

  • Klinikum Joh.Wolfg.Goethe-UNI Zentrum d. Psychiatrie Klinik f. Psychiatrie Psychosomatik

    Frankfurt, 60528

  • Universitätsklinikum Freiburg, Zentrum für Geriatrie und Gerontologie

    Freiburg im Breisgau, 79106

  • Universitätsklinikum des Saarlandes Klinik f. Psychiatrie und Psychotherapie

    Homburg/Saar, 66421

  • PANAKEIA - Arzneimittelforschung Leipzig GmbH

    Leipzig, 04275

  • Pharmakologisches Studienzentrum

    Mittweida, 09648

  • Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie

    München, 81675

Other trials in Germany

Brazil6 sites

  • Hospital das Clinicas - UFMG

    Belo Horizonte, Minas Gerais, 31270-901

  • CCBR - Brasilia

    Brasília, Federal District, 70200-730

  • Instituto de Neurologia de Curitiba

    Curitiba, Paraná, 81210-310

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul

  • Centro Psiquiatria Sandra Ruschel Ltda

    Rio de Janeiro, Rio de Janeiro, 22270-060

  • Clínica Dr. Norton Sayeg LTDA - EPP

    São Paulo, São Paulo, 04534-011

Other trials in Brazil

Taiwan5 sites

  • Changhua Christian Hospital; Neurology

    Changhua County, 500

  • Kaohsiung Medical University Hospital; Neurology

    Kaohsiung City, 807

  • Taipei Medical University - Shuang Ho Hospital - Neurology

    New Taipei City, 23561

  • National Taiwan University Hospital; Neurology

    Taipei, 100

  • Chang Gung Memorial Foundation - Linkou - Neurology

    Taoyuan, 333

Other trials in Taiwan

Australia4 sites

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Central Coast Neurosciences Research

    Erina, New South Wales, 2250

  • Hornsby Ku-ring-gai Hospital; Division of Rehabilitation & Aged Care

    Hornsby, New South Wales, 2077

  • The Queen Elizabeth Hospital; Neurology

    Woodville, South Australia, 5011

Other trials in Australia

Poland4 sites

  • NZOZ Dom Sue Ryder

    Bydgoszcz, 85-023

  • Centrum Medyczne Euromedis Sp. z o.o.

    Szczecin, 70-111

  • Centrum Medyczne NeuroProtect

    Warsaw, 01-684

  • NZOZ WCA

    Wroclaw, 53-659

Other trials in Poland

Portugal4 sites

  • Hospital de Braga; Servico de Neurologia

    Braga, 4710-243

  • HUC; Servico de Neurologia

    Coimbra, 3000-075

  • Hospital Pedro Hispano; Servico de Neurologia

    Matosinhos Municipality, 4464-513

  • Hospital Geral de Santo Antonio; Servico de Neurologia

    Porto, 4099-001

Other trials in Portugal

Argentina3 sites

  • Hospital Italiano

    Buenos Aires, C1181ACH

  • Universidad Maimonides

    Caba, C1405BCK

  • DAMIC

    Córdoba, X500 3DCE

Other trials in Argentina

Belgium3 sites

  • AZ Sint Jan

    Bruges, 8000

  • AZ Groeninge

    Kortrijk, 8500

  • UZ Leuven Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Israel3 sites

  • Rambam Medical Center

    Haifa, 3109601

  • Sheba Medical Center; Psychiatry Department

    Ramat Gan, 5262100

  • Tel Aviv Sourasky Medical Center; Department of Neurology

    Tel Aviv, 6423906

Other trials in Israel

Serbia3 sites

  • Clinic for Mental disorders Dr Laza Lazarevic

    Belgrade, 11000

  • Neurology clinic, Clinical Center of Serbia

    Belgrade, 11000

  • Clinic for neurology, Clinical Center Kragujevac

    Kragujevac, 34000

Other trials in Serbia

Turkey (Türkiye)3 sites

  • Hacettepe University Medical Faculty; Neurology

    Ankara, 06100

  • Istanbul University Istanbul School of Medicine; Neurology

    Istanbul, 34093

  • Ondokuz Mayis Univ. Med. Fac.; Neurology

    Samsun, 55139

Other trials in Turkey (Türkiye)

China2 sites

  • Beijing Union Hospital

    Beijing, 100730

  • Tianjin Medical University General Hospital

    Tianjin (天津), 300052

Other trials in China

Denmark2 sites

  • Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken

    Aarhus N, 8200

  • Rigshospitalet, Hukommelsesklinikken

    København Ø, 2100

Other trials in Denmark

Norway2 sites

  • Akershus universitetssykehus HF; Nevroklinikken S203

    Lørenskog, 1478

  • Oslo universitetssykehus HF Ullevål sykehus; Hukommelsesklinikken

    Oslo, 0450

Other trials in Norway

Peru2 sites

  • Clinica Internacional; Unidad De Investigacion

    Lima, 15001

  • Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia

    Lima, Lima 01

Other trials in Peru

Sweden2 sites

  • Skånes Universitetssjukhus Malmö, Minneskliniken

    Malmö, 211 46

  • Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry

    Mölndal, 431 41

Other trials in Sweden

Estonia1 site

  • Laane-Tallinna Keskhaigla

    Tallinn, 10617

Other trials in Estonia

South Africa1 site

  • Private Practice; the Osteoporosis Clinic

    Johannesburg, 2196

Other trials in South Africa

About this study

Official title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Crenezumab in Patients With Prodromal to Mild Alzheimer's Disease

This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (Q4W) for 100 weeks. The primary efficacy assessment will be performed at 105 weeks. The participants who do not enter open-label extension will enter for a long term follow-up period for up to 52 weeks after the last crenezumab dose (Week 153).

Being tested
Crenezumab, 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.

  • CrenezumabDrug

    Crenezumab was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.

  • PlaceboDrug

    Placebo was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.

Study groups in NCT03114657
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
Receives: Drug: Placebo
CrenezumabExperimentalParticipants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
Receives: Drug: Crenezumab

What is being measured

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

  1. Change From Baseline to Week 77 in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Scale Score

    The CDR-SB rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment = 0, questionable impairment = 0.5 and mild, moderate and severe impairment = 1, 2 and 3 respectively. The score range is from 0 to 18 with a high score indicating a high disease severity. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline for this primary endpoint. Data after 29 January 2019 are censored for the primary and secondary efficacy analyses to avoid potential biases due to investigators, participants, raters, etc. being potentially influenced by early closure of the study due to lack of efficacy.

    Measured: Baseline, Week 77

Secondary outcomes (21)

  1. Change From Baseline to Week 77 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13) Subscale Score

    The ADAS-Cog-13 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Most of these are assessed by tests although some are rated by the clinician on a 5-point scale. The ADAS-Cog-13 is the ADAS-Cog-11 with 2 further items: delayed word recall and total digit cancellation. The score range for ADAS-Cog-13 is from 0 to 85 with high scores representing severe dysfunction. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

    Measured: Baseline, Week 77

  2. Change From Baseline to Week 77 in Alzheimer's Disease Assessment Scale-Cognition 11 (ADAS-Cog-11) Subscale Score

    The ADAS-Cog-11 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Most of these are assessed by tests although some are rated by the clinician on a 5-point scale. The score range for ADAS-Cog-11 is from 0 to 70 with high scores representing severe dysfunction. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

    Measured: Baseline, Week 77

  3. Change From Baseline to Week 77 on Severity of Dementia, Assessed Using the CDR-Global Score (CDR-GS)

    The CDR-GS represents a semi-structured interview which rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care) on a 5-point scale in which CDR 0 = no dementia and CDR 0.5, 1, 2 or 3 = questionable, mild, moderate or severe dementia respectively. The range in scores for the CDR-GS is from 0 to 3 and a high score on the CDR-GS would indicate a high disease severity. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

    Measured: Baseline, Week 77

  4. Change From Baseline to Week 77 on Severity of Dementia, Assessed Using the Mini Mental State Evaluation (MMSE)

    The MMSE is a set of standardized questions used to evaluate possible cognitive impairment and help stage the severity level of this impairment. The questions target 6 areas: orientation, registration, attention, short-term recall, language and constructional praxis/visuospatial abilities. The scores on the MMSE range from 0 to 30, with higher scores indicating better function. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

    Measured: Baseline, Week 77

  5. Change From Baseline to Week 77 on Function as Assessed by (ADCS-ADL) Total Score

    The ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living) is the scale most widely used to assess functional outcomes in participants with AD. The ADCS-ADL covers both basic ADL (e.g., eating and toileting) and more complex 'instrumental' ADL or iADL (e.g., using the telephone, managing finances and preparing a meal). The ADCS-ADL consists of 23 questions with a score range of 0 to 78 where a higher score represents better function. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

    Measured: Baseline, Week 77

  6. Change From Baseline to Week 77 on Function as Assessed by (ADCS-iADL) Instrumental Score

    The ADCS-iADL (Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living) measures activities such as using the telephone, managing finances and preparing a meal. The ADCS-iADL consists of 16 questions with a score range of 0 to 56 where a higher score represents better function. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

    Measured: Baseline, Week 77

  7. Change From Baseline to Week 77 on Function as Assessed by the Functional Activities Questionnaire (FAQ) Total Score

    The Functional Activities Questionnaire (FAQ) is an instrument consisting of 10 items and assesses instrumental, social and cognitive functioning. The score range is from 0 to 30 with higher scores representing higher impairment. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

    Measured: Baseline, Week 77

  8. Change From Baseline to Week 77 on a Measure of Dependence Level Assessed From the ADCS-ADL Score

    The ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living) is the scale most widely used to assess functional outcomes in participants with AD. The ADCS-ADL covers both basic ADL (e.g., eating and toileting) and more complex 'instrumental' ADL or iADL (e.g., using the telephone, managing finances and preparing a meal). The ADCS-ADL consists of 23 questions with a score range of 0 to 78 where a higher score represents better function. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

    Measured: Baseline, Week 77

  9. Change From Baseline to Week 53 on Behavior in Neuropsychiatric Inventory Questionnaire (NPI-Q) Total Score

    The NPI-Q evaluates 12 neuropsychiatric disturbances common in dementia: delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavioral disturbances and appetite/eating abnormalities. The severity of each neuropsychiatric symptom is rated on a 3-point scale (mild, moderate and marked). The total severity score range is from 0 to 36 with higher scores representing higher severity. Difference in mean change from Baseline to Week 53 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures adjusting for disease severity, APOEe4 status, geographic region and the use/non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

    Measured: Baseline, Week 53

  10. Quality of Life-Alzheimer's Disease (QoL-AD) Scale Score

    The QoL-AD (Quality of Life - Alzheimer's Disease) scale assesses QoL in participants who have dementia. The QoL-AD consists of 13 items covering aspects of participants' relationships with friends and family, physical condition, mood, concerns about finances and overall assessment of QoL. Items are rated on 4-point Likert-type scales ranging from 1 [poor] to 4 [excellent]. The score range is from 13 to 52, with higher scores indicating a better QoL. The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

    Measured: Baseline, Week 77

  11. Zarit Caregiver Interview for Alzheimer's Disease (ZCI-AD) Scale Score

    The ZCI-AD is a modified version of the Zarit Burden Interview, which was originally designed to reflect the stresses experienced by caregivers of people with dementia. This modified version includes slight modifications in item and title wording (e.g., removal of "your relative" to refer directly to the patient, removal of "burden" from title) and the use of 11-point numerical rating scales. The ZCI-AD scale consists of a total of 30 items. Total scores will be calculated with a total score range from 0 to 300 (higher scores indicate a higher burden on the caregiver). The difference in mean change from Baseline to Week 53 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

    Measured: Baseline, Week 53

  12. European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Domain Scores for Participants

    The EQ-5D is a standardized measure of health status designed to provide a simple generic measure of health for clinical and economic appraisal. It is broadly applicable across a wide range of health conditions and treatment. The EQ-5D assesses five domains to provide a health state index. These are anxiety/depression, pain/discomfort, usual activities, mobility, and self-care. The scores on the EQ-5D ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

    Measured: Baseline, Week 77

  13. European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Domain Scores for Caregivers

    The EQ-5D is a standardized measure of health status designed to provide a simple generic measure of health for clinical and economic appraisal. It is broadly applicable across a wide range of health conditions and treatment. The EQ-5D assesses five domains to provide a health state index. These are anxiety/depression, pain/discomfort, usual activities, mobility, and self-care. The scores on the EQ-5D ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). The difference in mean change from Baseline to Week 77 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

    Measured: Baseline, Week 77

  14. Percentage of Participants With Adverse Event (AEs) and Serious Adverse Event (SAEs)

    An Adverse Event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

    Measured: Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).

  15. Percentage of Participants With Anti-Crenezumab Antibodies

    Participants were considered positive or negative for ADA based on their baseline and post-baseline sample results. The number and percentage of participants with confirmed positive ADA levels were determined for Crenezumab and Placebo groups. The prevalence of ADA at baseline was calculated as the proportion of participants with confirmed positive ADA levels at baseline relative to the total number of participants with a sample available at baseline. The incidence of treatment-emergent ADAs was determined as the proportion of participants with confirmed post-baseline positive ADAs relative to the total number of participants that had at least one post-baseline sample available for ADA analysis.

    Measured: Baseline up to Week 105

  16. Serum Concentration of Crenezumab

    Serum concentration data for Crenezumab will be tabulated and summarized. Descriptive summary statistics will include the arithmetic mean and SD. Since a sparse PK sampling design is being used, population (non-linear mixed-effects) modeling will be used to analyze the dose concentration-time data of crenezumab. Information from other clinical studies may be incorporated to establish the PK model. Please note that Post-dose samples were not collected at Weeks 5, 13, 37, 53 and 77.

    Measured: Pre-infusion (0 hour), 60-90 minutes post-infusion on Day 1 Week 1 and on Week 25; Weeks 13 (Pre-dose), 37 (Pre-dose), 53 (Pre-dose) and 77 (Pre-dose) (infusion length = as per the Pharmacy Manual)

  17. Plasma Amyloid Beta (Abeta) 40 Concentrations

    Plasma Abeta 40 concentrations will be measured over time and descriptive summary statistics will include the arithmetic mean and SD. Please note that Pre-dose samples were only collected at Weeks 1 and 53.

    Measured: Week 1 Day 1; Weeks 53

  18. Plasma Amyloid Beta (Abeta) 42 Concentrations

    Plasma Abeta 42 concentrations will be measured over time and descriptive summary statistics will include the arithmetic mean and SD. Please note that Pre-dose samples were only collected at Weeks 1 and 53.

    Measured: Week 1 Day 1; Weeks 53

  19. Percentage Change From Baseline to Week 105 in Whole Brain Volume as Determined by Magnetic Resonance Imaging (MRI)

    Percentage Change in Whole Brain Volume will be measured over time and descriptive summary statistics will include the arithmetic mean, median, range, SD, and coefficient of variation, as appropriate. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

    Measured: Baseline, Week 105

  20. Percentage Change From Baseline to Week 105 in Ventricle Volume as Determined by Magnetic Resonance Imaging (MRI)

    Percentage Change in Ventricle Volume will be measured over time and descriptive summary statistics will include the arithmetic mean, median, range, SD, and coefficient of variation, as appropriate. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

    Measured: Baseline, Week 105

  21. Percentage Change From Baseline to Week 105 in Hippocampal Volume as Determined by Magnetic Resonance Imaging (MRI)

    Percentage Change in Hippocampal Volume will be measured over time and descriptive summary statistics will include the arithmetic mean, median, range, SD, and coefficient of variation, as appropriate. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.

    Measured: Baseline, Week 105

Timeline

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

  1. First posted14 Apr 2017
  2. Study start29 Mar 2017
  3. Primary completion11 Jun 2019
  4. Study completion11 Jun 2019

Why it stopped: This study was discontinued due to an interim analysis in the BN29552 study, which indicated that Crenezumab was unlikely to meet its primary endpoint.

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
Double blind
Who is masked
Participant, Investigator
Enrolment
806 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03114657
Sponsor's protocol ID
BN29553
Other IDs
2016-003288-20, 2016
Acronym
CREAD 2
Status last verified
Jun 2020
First submitted
28 Mar 2017
Last updated
16 Jul 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Hibar DP, Bauer A, Rabe C, Borlinghaus N, Jethwa A, Kollmorgen G, Di Domenico A, Zetterberg H, Blennow K, Masters CL, Sperling RA, Bittner T. Elecsys pTau217 plasma immunoassay detection of amyloid pathology in clinical cohorts. Alzheimers Dement. 2026 Jan;22(1):e71009. doi: 10.1002/alz.71009.

    PubMed 41537338

  • Chandler JM, Lansdall CJ, Ye W, McDougall F, Belger M, Toth B, Mi X, Sink KM, Atkins AS. The Alzheimer's Disease Cooperative Study - Activities of Daily Living dependence score: revision and validation of an algorithm evaluating patient dependence across the spectrum of AD severity. J Prev Alzheimers Dis. 2025 Sep;12(8):100261. doi: 10.1016/j.tjpad.2025.100261. Epub 2025 Jul 1.

    PubMed 40603145

  • Teng E, Manser PT, Shah M, Pickthorn K, Hu N, Djakovic S, Swendsen H, Blendstrup M, Faccin G, Ostrowitzki S, Sink KM. The Use of Episodic Memory Tests for Screening in Clinical Trials for Early Alzheimer's Disease: A Comparison of the Free and Cued Selective Reminding Test (FCSRT) and the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). J Prev Alzheimers Dis. 2023;10(1):41-49. doi: 10.14283/jpad.2022.101.

    PubMed 36641609

  • Ostrowitzki S, Bittner T, Sink KM, Mackey H, Rabe C, Honig LS, Cassetta E, Woodward M, Boada M, van Dyck CH, Grimmer T, Selkoe DJ, Schneider A, Blondeau K, Hu N, Quartino A, Clayton D, Dolton M, Dang Y, Ostaszewski B, Sanabria-Bohorquez SM, Rabbia M, Toth B, Eichenlaub U, Smith J, Honigberg LA, Doody RS. Evaluating the Safety and Efficacy of Crenezumab vs Placebo in Adults With Early Alzheimer Disease: Two Phase 3 Randomized Placebo-Controlled Trials. JAMA Neurol. 2022 Nov 1;79(11):1113-1121. doi: 10.1001/jamaneurol.2022.2909.

    PubMed 36121669

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Crenezumab in people with Alzheimer's Disease, run by Hoffmann-La Roche at 211 sites in 27 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 11 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 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 211 sites in United States, Japan, Spain, Canada, Italy and 22 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 16 Jul 2020). 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 to Week 77 in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Scale Score (time frame: Baseline, Week 77). 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 NCT03114657, which also lists 4 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 16 Jul 2020.

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