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

NCT03114657 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: BN295532016-003288-20
• Study Type: interventional
• Target: 806
• Locations: 25 countries
• Sites: 188

Brief 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. 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).

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (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.

  Baseline, Week 77

Secondary Outcomes (21)

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

  Baseline, Week 77

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

  Baseline, Week 77

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

  Baseline, Week 77

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

  Baseline, Week 77

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

  Baseline, Week 77

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.

Drug: Placebo

Crenezumab

EXPERIMENTAL

Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.

Drug: Crenezumab

Interventions

Crenezumab DRUG

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

Crenezumab

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (211)

Imaging End Points Clinical Research

Scottsdale, Arizona, 85258, United States

Location

Health Initiatives Research, PLLC

Fayetteville, Arkansas, 72703, United States

Location

Clinical Trials Inc.

Little Rock, Arkansas, 72205, United States

Location

Neuro-Therapeutics Inc.

Pasadena, California, 91105, United States

Location

Desert Valley Medical Group

Rancho Mirage, California, 92270, United States

Location

Anderson Clinical Research, Inc.

Redlands, California, 92374, United States

Location

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

Sacramento, California, 95817, United States

Location

UCSF - Memory and Aging Center

San Francisco, California, 94158, United States

Location

MCB Clinical Research Centers

Colorado Springs, Colorado, 80910, United States

Location

Research Center for Clinical Studies, Inc.

Norwalk, Connecticut, 06851, United States

Location

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

Stamford, Connecticut, 06905, United States

Location

Georgetown University Hospital

Washington D.C., District of Columbia, 20057, United States

Location

JEM Research LLC

Atlantis, Florida, 33462, United States

Location

Bradenton Research Center

Bradenton, Florida, 34205, United States

Location

Neuropsychiatric Research; Center of Southwest Florida

Fort Myers, Florida, 33912, United States

Location

Alzheimer's Research and Treatment Center

Lake Worth, Florida, 33414, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

Bioclinica Research

Orlando, Florida, 32806, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Columbus Memory Center

Columbus, Georgia, 31909, United States

Location

Lake Charles Clinical Trials, LLC

Lake Charles, Louisiana, 70601, United States

Location

Alzheimers Disease Center; Neurology

Winchester, Massachusetts, 01890, United States

Location

Health Partners Institute for Education and Research

Saint Paul, Minnesota, 55130, United States

Location

Precise Research Centers

Flowood, Mississippi, 39232, United States

Location

University of Nebraska Medical Center; Dept of Neurological Sciences

Omaha, Nebraska, 68198-8440, United States

Location

Cleveland Clinic Lou Ruvo; Center for Brain Research

Las Vegas, Nevada, 89106, United States

Location

The Cognitive and Research Center of New Jersey

Summit, New Jersey, 07081, United States

Location

Advanced Memory Research Institute of NJ

Toms River, New Jersey, 08755, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Burke Rehabilitation Hospital

White Plains, New York, 10605, United States

Location

Behavioral Health Research

Charlotte, North Carolina, 28211, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

University of Cincinnati; Department of Psychiatry and Behavioral Neuroscience

Cincinnati, Ohio, 45219, United States

Location

Ohio State University; College of Medicine

Columbus, Ohio, 43210, United States

Location

Dayton Center for Neuro Disorders

Dayton, Ohio, 45459, United States

Location

Summit Research Network Inc.

Portland, Oregon, 97210, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Northeastern Pennsylvania Memory

Plains, Pennsylvania, 18705, United States

Location

Abington Neurological Associates

Willow Grove, Pennsylvania, 19090, United States

Location

Neurology Clinic PC

Cordova, Tennessee, 38018, United States

Location

Senior Adults Specialty Research

Austin, Texas, 78757, United States

Location

Gadolin Research, LLC

Beaumont, Texas, 77702, United States

Location

Texas Neurology PA

Dallas, Texas, 75214, United States

Location

Kerwin Research Center, LLC

Dallas, Texas, 75231, United States

Location

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

Houston, Texas, 77030, United States

Location

Clinical Trials of Texas, Inc

San Antonio, Texas, 78229, United States

Location

Sentara Medical Group

Norfolk, Virginia, 23507, United States

Location

National Clinical Research Inc.-Richmond

Richmond, Virginia, 23294, United States

Location

Hospital Italiano

Buenos Aires, C1181ACH, Argentina

Location

Universidad Maimonides

Caba, C1405BCK, Argentina

Location

DAMIC

Córdoba, X500 3DCE, Argentina

Location

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

Location

Central Coast Neurosciences Research

Erina, New South Wales, 2250, Australia

Location

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

Hornsby, New South Wales, 2077, Australia

Location

The Queen Elizabeth Hospital; Neurology

Woodville, South Australia, 5011, Australia

Location

AZ Sint Jan

Bruges, 8000, Belgium

Location

AZ Groeninge

Kortrijk, 8500, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

CCBR - Brasilia

Brasília, Federal District, 70200-730, Brazil

Location

Hospital das Clinicas - UFMG

Belo Horizonte, Minas Gerais, 31270-901, Brazil

Location

Instituto de Neurologia de Curitiba

Curitiba, Paraná, 81210-310, Brazil

Location

Centro Psiquiatria Sandra Ruschel Ltda

Rio de Janeiro, Rio de Janeiro, 22270-060, Brazil

Location

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, Brazil

Location

Clínica Dr. Norton Sayeg LTDA - EPP

São Paulo, São Paulo, 04534-011, Brazil

Location

OCT Research ULC

Kelowna, British Columbia, V1Y 1Z9, Canada

Location

Vancouver Island Health Authority

Victoria, British Columbia, V8R 1J8, Canada

Location

True North Clinical Research-Halifax

Halifax, Nova Scotia, B3S 1M7, Canada

Location

True North Clinical Research Kentville

Kentville, Nova Scotia, B4N 5E3, Canada

Location

Providence Care; Mental Health Services

Kingston, Ontario, K7L 4X3, Canada

Location

Parkwood Hospital; Geriatric Medicine

London, Ontario, N6C 5J1, Canada

Location

Kawartha Centre - Redefining Healthy Aging

Peterborough, Ontario, K9H 2P4, Canada

Location

The Centre for Memory and Aging

Toronto, Ontario, M4G 3E8, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1N9, Canada

Location

Devonshire Clinical Research Inc.

Woodstock, Ontario, N4S 5P5, Canada

Location

Clinique Neuro Rive-Sud

Greenfield Park, Quebec, J4V 2J2, Canada

Location

ALPHA Recherche Clinique

Québec, G3K 2P8, Canada

Location

Beijing Union Hospital

Beijing, 100730, China

Location

Tianjin Medical University General Hospital

Tianjin (天津), 300052, China

Location

Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken

Aarhus N, 8200, Denmark

Location

Rigshospitalet, Hukommelsesklinikken

København Ø, 2100, Denmark

Location

Laane-Tallinna Keskhaigla

Tallinn, 10617, Estonia

Location

Hopital Pellegrin; Cmrr Aquitaine

Bordeaux, 33076, France

Location

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

Colmar, 68000, France

Location

Hopital Roger Salengro; Service de Neurologie

Lille, France

Location

CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique

Limoges, 87042, France

Location

Hopital Broca

Paris, 75013, France

Location

CH Pitie Salpetriere; IM2A

Paris, 75651, France

Location

Hôpital Maison Blanche

Reims, 51092, France

Location

CHU Rennes - Hopital Pontchaillou

Rennes, 35033, France

Location

CHU de Rouen Hopital; Service de Neurologie

Rouen, 76031, France

Location

Hop Guillaume Et Rene Laennec; Cmrr St Herblain

Saint-Herblain, 44800, France

Location

Hopital des Charpennes

Villeurbanne, 69100, France

Location

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

Berlin, 13125, Germany

Location

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

Frankfurt, 60528, Germany

Location

Universitätsklinikum Freiburg, Zentrum für Geriatrie und Gerontologie

Freiburg im Breisgau, 79106, Germany

Location

Universitätsklinikum des Saarlandes Klinik f. Psychiatrie und Psychotherapie

Homburg/Saar, 66421, Germany

Location

PANAKEIA - Arzneimittelforschung Leipzig GmbH

Leipzig, 04275, Germany

Location

Pharmakologisches Studienzentrum

Mittweida, 09648, Germany

Location

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

München, 81675, Germany

Location

Rambam Medical Center

Haifa, 3109601, Israel

Location

Sheba Medical Center; Psychiatry Department

Ramat Gan, 5262100, Israel

Location

Tel Aviv Sourasky Medical Center; Department of Neurology

Tel Aviv, 6423906, Israel

Location

Azienda Ospedaliera Universitaria Policlinico Tor Vergata; Neurologia

Rome, Lazio, 00133, Italy

Location

Umberto I Policlinico di Roma-Università di Roma La Sapienza

Rome, Lazio, 00185, Italy

Location

Ospedale San Giovanni Calibita Fatebenefratell;Neurologia

Rome, Lazio, 00186, Italy

Location

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

Brescia, Lombardy, 25125, Italy

Location

Irccs Multimedica Santa Maria; Unita' Di Neurologia

Castellanza, Lombardy, 21053, Italy

Location

IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria

Milan, Lombardy, 20132, Italy

Location

Fondazione IRCCS Istituto Nazionale Neurologico Besta; UO Neuropatologia

Milan, Lombardy, 20133, Italy

Location

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

Milan, Lombardy, 20148, Italy

Location

Ospedale Casati Passirana di Rho; Centro Regionale Alzheimer

Passirana, Lombardy, 20017, Italy

Location

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

Pozzilli, Molise, 86077, Italy

Location

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

Turin, Piedmont, 10126, Italy

Location

A.O. Universitaria Pisana; Neurologia

Pisa, Tuscany, 56126, Italy

Location

National Center for Geriatrics and Gerontology

Aichi, 474-8511, Japan

Location

Inage Neurology and Memory Clinic

Chiba, 263-0043, Japan

Location

Fukuoka Mirai Hospital

Fukuoka, 813-0017, Japan

Location

National Hospital Organization Hiroshima-Nishi Medical Center

Hiroshima, 739-0696, Japan

Location

Tsukazaki Hospital

Hyōgo, 671-1227, Japan

Location

Kagawa Prefectural Central Hospital

Kagawa, 760-8557, Japan

Location

Fujisawa City Hospital

Kanagawa, 251-8550, Japan

Location

National Hospital Organization Sagamihara National Hospital

Kanagawa, 252-0392, Japan

Location

Ijinkai Takeda General Hospital

Kyoto, 601-1495, Japan

Location

Rakuwakai Otowarehabilitation Hospital

Kyoto, 607-8113, Japan

Location

National Hospital Organization Matsumoto Medical Center

Nagano, 399-8701, Japan

Location

Iwate Medical University Hospital

Numakunai, 028-3695, Japan

Location

Katayama Medical Clinic

Okayama, 710-0813, Japan

Location

Osaka University Hospital

Osaka, 565-0871, Japan

Location

Asakayama General Hospital

Osaka, 590-0018, Japan

Location

NHO Shizuoka Institute of Epilepsy and Neurological Disorders

Shizuoka, 420-8688, Japan

Location

Kanto Central Hospital

Tokyo, 158-8531, Japan

Location

Tokyo Medical University Hospital

Tokyo, 160-0023, Japan

Location

Shinjuku Research Park Clinic

Tokyo, 169-0073, Japan

Location

Tokyo Metropolitan Geriatric Hospital

Tokyo, 173-0015, Japan

Location

National Center of Neurology and Psychiatry

Tokyo, 187-8551, Japan

Location

Tokyo Medical University Hachioji Medical Center

Tokyo, 193-0998, Japan

Location

Akershus universitetssykehus HF; Nevroklinikken S203

Lørenskog, 1478, Norway

Location

Oslo universitetssykehus HF Ullevål sykehus; Hukommelsesklinikken

Oslo, 0450, Norway

Location

Clinica Internacional; Unidad De Investigacion

Lima, 15001, Peru

Location

Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia

Lima, Lima 01, Peru

Location

NZOZ Dom Sue Ryder

Bydgoszcz, 85-023, Poland

Location

Centrum Medyczne Euromedis Sp. z o.o.

Szczecin, 70-111, Poland

Location

Centrum Medyczne NeuroProtect

Warsaw, 01-684, Poland

Location

NZOZ WCA

Wroclaw, 53-659, Poland

Location

Hospital de Braga; Servico de Neurologia

Braga, 4710-243, Portugal

Location

HUC; Servico de Neurologia

Coimbra, 3000-075, Portugal

Location

Hospital Pedro Hispano; Servico de Neurologia

Matosinhos Municipality, 4464-513, Portugal

Location

Hospital Geral de Santo Antonio; Servico de Neurologia

Porto, 4099-001, Portugal

Location

LLC Baltic Medicine

Saint Petersburg, Sankt-Peterburg, 194356, Russia

Location

State Healthcare Institution of Sverdlovsk Region Sverdlovsk Regional Clinical Psychiatric Hospita

Yekaterinburg, Sverdlovsk Oblast, 620030, Russia

Location

State Autonomous Healthcare Institution "Republican Clinical Neurological Center

Kazan', 420021, Russia

Location

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

Kazan', 420101, Russia

Location

Institution of RAMS (Mental Health Research Center of RAMS)

Moscow, 115522, Russia

Location

City Clinical Psychiatry Hospital #1

Nizhny Novgorod, 603155, Russia

Location

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

Saint Petersburg, 190121, Russia

Location

Nebbiolo Center for Clinical Trials

Tomsk, 634009, Russia

Location

Clinic for Mental disorders Dr Laza Lazarevic

Belgrade, 11000, Serbia

Location

Neurology clinic, Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

Clinic for neurology, Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

Private Practice; the Osteoporosis Clinic

Johannesburg, 2196, South Africa

Location

Dong-A University Hospital

Busan, 49201, South Korea

Location

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 13605, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Hanyang University Seoul Hospital

Seoul, 04763, South Korea

Location

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Seoul St Mary's Hospital

Seoul, 06591, South Korea

Location

Borame Medical Center

Seoul, 07061, South Korea

Location

Hospital General Universitario de Elche; Servicio de Neurología

Elche, Alicante, 03203, Spain

Location

Fundació ACE

BArcelon, Barcelona, 08034, Spain

Location

Hospital General De Catalunya; Servicio de Neurologia

Sant Cugat del Vallès, Barcelona, 8195, Spain

Location

Hospital Mutua De Terrasa; Servicio de Neurologia

Terrassa, Barcelona, 08222, Spain

Location

Hospital Virgen del Puerto. Servicio de Neurología

Plasencia, Caceres, 10600, Spain

Location

Hospital Universitario Marques de Valdecilla; Servicio de Neurología

Santander, Cantabria, Spain

Location

Hospital la Magdalena; Servicio de Neurologia

Castellon, Castellon, 12004, Spain

Location

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

Salt, Girona, 17090, Spain

Location

Policlínica Guipuzkoa; Servicio de Neurología

Donosti-San Sebastián, Guipuzcoa, 20014, Spain

Location

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

Santiago de Compostela, LA Coruña, 15706, Spain

Location

Hospital San Pedro; Servicio de Neurología

Logroño, La Rioja, 26006, Spain

Location

Hospital Quiron de Madrid; Servicio de Neurologia

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Clinica Universitaria de Navarra; Servicio de Neurología

Pamplona, Navarre, 31008, Spain

Location

CAE Oroitu

Barakaldo, Vizcaya, 48903, Spain

Location

Hospital Perpetuo Socorro, Servicio de Geriatria

Albacete, 2006, Spain

Location

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

Barcelona, 08025, Spain

Location

Hospital Universitario de Burgos. Servicio de Neurología

Burgos, 09006, Spain

Location

Hospital Universitario Reina Sofia; Servicio de Neurologia

Córdoba, 14011, Spain

Location

Hospital Ramon y Cajal; Servicio de Neurologia

Madrid, 28034, Spain

Location

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

Salamanca, 37005, Spain

Location

Hospital Universitario Virgen Macarena; Servicio de Neurologia

Seville, 41009, Spain

Location

Skånes Universitetssjukhus Malmö, Minneskliniken

Malmo, 211 46, Sweden

Location

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

Mölndal, 431 41, Sweden

Location

Changhua Christian Hospital; Neurology

Changhua County, 500, Taiwan

Location

Kaohsiung Medical University Hospital; Neurology

Kaohsiung City, 807, Taiwan

Location

Taipei Medical University - Shuang Ho Hospital - Neurology

New Taipei City, 23561, Taiwan

Location

National Taiwan University Hospital; Neurology

Taipei, 100, Taiwan

Location

Chang Gung Memorial Foundation - Linkou - Neurology

Taoyuan District, 333, Taiwan

Location

Hacettepe University Medical Faculty; Neurology

Ankara, 06100, Turkey (Türkiye)

Location

Istanbul University Istanbul School of Medicine; Neurology

Istanbul, 34093, Turkey (Türkiye)

Location

Ondokuz Mayis Univ. Med. Fac.; Neurology

Samsun, 55139, Turkey (Türkiye)

Location

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

Cheltenham, GL53 9DZ, United Kingdom

Location

Surrey and Borders NHS Foundation Trust; Brain Science Research Unit

Chertsey, KT16 0AE, United Kingdom

Location

Sussex Partnership NHS Foundation Trust; Cognitive Treatment and Research unit

Crowborough, TN6 1HB, United Kingdom

Location

Ninewells Hospital

Dundee, DD12 9SY, United Kingdom

Location

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

Edinburgh, EH4 2XU, United Kingdom

Location

Queen Elizabeth University Hospital; Clinical Research Facility

Glasgow, G51 4TF, United Kingdom

Location

RE:Cognition Health

London, W1G 9RU, United Kingdom

Location

Charing Cross Hospital; Imperial Memory Unit, Level 10 West

London, W6 8RF, United Kingdom

Location

Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

Location

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

University Southampton NHS Foundation Trust; Wessex Neurologica Centre

Southampton, SO166YD, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 41537338 DERIVED

• 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.

  PMID: 40603145 DERIVED

• 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.

  PMID: 36641609 DERIVED

• 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.

  PMID: 36121669 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

crenezumab

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

This study was discontinued due to an interim analysis in the BN29552 study, which indicated that Crenezumab was unlikely to meet its primary endpoint. No participants reached Week 105 for primary and secondary efficacy endpoints.

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 14, 2017
• Study Start: March 29, 2017
• Primary Completion: June 11, 2019
• Study Completion: June 11, 2019
• Last Updated: July 16, 2020
• Results First Posted: July 16, 2020

Record last verified: 2020-06

Locations

GB (11); SE (3); IT (12); AU (4); JP (22); NO (2); RU (8); ES (1); TU (3); US (48); BE (3); CA (12); PL (4); PT (4); AR (3); DE (7); IL (3); BR (6); FR (11); CN (2); DK (2); PE (2); ZA (1); KR (9); TW (5)