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

NCT02670083 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: BN295522015-003034-27
• Study Type: interventional
• Target: 813
• Locations: 29 countries
• Sites: 195

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 final efficacy and safety assessment will be performed 52 weeks after the last crenezumab dose. Participants will then have the option to enter the Open Label Extension (OLE) study if eligible. Participants who do not enter the OLE study will have additional follow-up visits at 16 and 52 weeks after the last dose, primarily for safety and also for limited efficacy assessments.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 105 in Clinical Dementia Rating-Sum of Boxes (CDR-SB) 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 105 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 105

Secondary Outcomes (20)

• Change From Baseline to Week 105 on Cognition, as Assessed by Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) (Subscale) 13 (ADAS-Cog-13)

  Baseline, Week 105

• Change From Baseline to Week 105 on Cognition, as Assessed by Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) (Subscale) 11 (ADAS-Cog-11)

  Baseline, Week 105

• Change From Baseline to Week 105 on Severity of Dementia, Assessed Using the CDR-Global Score (CDR-GS)

  Baseline, Week 105

• Change From Baseline to Week 105 on Severity of Dementia, Assessed Using the Mini Mental State Evaluation (MMSE)

  Baseline, Week 105

• Change From Baseline to Week 105 on Function as Assessed by the ADCS-ADL Total Score

  Baseline, Week 105

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 (196)

Banner Alzheimer's Institute

Phoenix, Arizona, 85006, United States

Location

Pharmacology Research Inst

Encino, California, 91316, United States

Location

Collaborative Neuroscience Network Inc.

Long Beach, California, 90502, United States

Location

Alliance for Wellness, dba Alliance for Research

Long Beach, California, 90807, United States

Location

Pharmacology Research Institute

Los Alamitos, California, 90720, United States

Location

USC Keck School Of Medicine

Los Angeles, California, 90033, United States

Location

UCLA Medical Center, Department of Neurology

Los Angeles, California, 90095, United States

Location

Pharmacology Research Inst

Newport Beach, California, 92660, United States

Location

Shankle Clinic

Newport Beach, California, 92663, United States

Location

Stanford Univ Medical Center

Palo Alto, California, 94304, 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

Neurological Research Inst

Santa Monica, California, 90404, United States

Location

North Bay Neuro Science Institute

Sebastopol, California, 95472, United States

Location

Associated Neurologists PC - Danbury

Danbury, Connecticut, 06810, United States

Location

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Location

Yale University School Of Medicine

New Haven, Connecticut, 06510, United States

Location

Research Center for Clinical Studies, Inc.

Norwalk, Connecticut, 06851, United States

Location

Bradenton Research Center

Bradenton, Florida, 34205, United States

Location

Quantum Laboratories

Deerfield Beach, Florida, 33064, United States

Location

Brain Matters Research, Inc.

Delray Beach, Florida, 33445, United States

Location

Galiz Research, LLC

Hialeah, Florida, 33016, United States

Location

Jacksonville Center For Clinical Research

Jacksonville, Florida, 32216, United States

Location

Alzheimer's Research and Treatment Center

Lake Worth, Florida, 33414, United States

Location

Merritt - Island Medical Research

Merritt Island, Florida, 32952, United States

Location

Miami Jewish Health Systems

Miami, Florida, 33137, 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

Johnnie B. Byrd Sr. Alzheimer's Center & Research Institute

Tampa, Florida, 33613, United States

Location

Stedman Clinical Trials, LLC

Tampa, Florida, 33613, United States

Location

Compass Research

The Villages, Florida, 32162, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

NeuroStudies.net, LLC

Decatur, Georgia, 30033, United States

Location

Alexian Brothers Neurosci Inst

Elk Grove Village, Illinois, 60007, United States

Location

Southern Illinois University, School of Medicine

Springfield, Illinois, 62702, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MidAmerica Neuroscience Institute

Prairie Village, Kansas, 66206, United States

Location

Maine Research Associates

Auburn, Maine, 04210, United States

Location

MMP Neurology

Scarborough, Maine, 04074, United States

Location

Springfield Neurology Associates

Springfield, Massachusetts, 01104, United States

Location

Precise Research Centers

Flowood, Mississippi, 39232, United States

Location

The Cognitive and Research Center of New Jersey

Springfield, New Jersey, 07081, United States

Location

Advanced Memory Research Institute of NJ

Toms River, New Jersey, 08755, United States

Location

Albany Medical Faculty Physicians COmmunity Division. The Neurology Group

Albany, New York, 12206, United States

Location

Neurological Associates of Albany, PC

Albany, New York, 12208, United States

Location

Dent Neurological Institute

Amherst, New York, 14226, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

South Shore Neurologic Associates P.C.

Patchogue, New York, 11772, United States

Location

Behavioral Health Research

Charlotte, North Carolina, 28211, United States

Location

Guilford Neurologic Associates

Greensboro, North Carolina, 27401, United States

Location

Valley Medical Primary Care

Centerville, Ohio, 45459, United States

Location

Insight Clinical Trials LLC

Shaker Heights, Ohio, 44122, United States

Location

Oklahoma Clinical Research

Oklahoma City, Oklahoma, 73112, United States

Location

Cutting Edge Research Group

Oklahoma City, Oklahoma, 73116, United States

Location

Central States Research

Tulsa, Oklahoma, 74136, United States

Location

Summit Research Network Inc.

Portland, Oregon, 97210, United States

Location

Drexel Univ College of Med; Clinical Research Group

Philadelphia, Pennsylvania, 19102, United States

Location

Abington Neurological Associates

Willow Grove, Pennsylvania, 19090, United States

Location

Senior Adults Specialty Research

Austin, Texas, 78757, United States

Location

Kerwin Research Center, LLC

Dallas, Texas, 75231, United States

Location

University of North Texas Health Science Center; Fort Worth Patient Care Center

Fort Worth, Texas, 76107, United States

Location

Sentara Medical Group

Norfolk, Virginia, 23507, United States

Location

National Clinical Research Inc.-Richmond

Richmond, Virginia, 23294, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

The Queen Elizabeth Hospital; Neurology

Woodville, South Australia, 5011, Australia

Location

Caulfield Hospital; Aged Psychiatry Research Unit

Caulfield, Victoria, 3162, Australia

Location

Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre

Heidelberg West, Victoria, 3081, Australia

Location

Neurodegenerative Disorders Research; Neurology

West Perth, Western Australia, 6005, Australia

Location

Konventhospital Barmherzige Brüder; Neurologie I

Linz, 4021, Austria

Location

UZ Gent

Ghent, 9000, Belgium

Location

ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine

Sofia, 1407, Bulgaria

Location

Alexandrovska hospital; Neurology Department

Sofia, 1431, Bulgaria

Location

Vancouver Hospital - UBC Hospital Site

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Vancouver Island Health Authority

Victoria, British Columbia, V8R 1J8, Canada

Location

Parkwood Hospital; Geriatric Medicine

London, Ontario, N6C 5J1, Canada

Location

Bruyere Continuing Care

Ottawa, Ontario, K1N 5C8, 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

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Devonshire Clinical Research Inc.

Woodstock, Ontario, N4S 5P5, Canada

Location

CHA Hopital de I enfant-Jesus

Québec, Quebec, G1J 1Z4, Canada

Location

Hospital Clínica Biblica

San José, 10101, Costa Rica

Location

ICIMED Instituto de Investigación en Ciencias Médicas

San José, 10108, Costa Rica

Location

Clinical Hospital Centre Zagreb;Clinic for Neurology

Zagreb, 10000, Croatia

Location

Charles University, Medical faculty, Hradec Kralove ;Department of Neurology

Hradec Králové, 500 05, Czechia

Location

General Teaching Hospital, Departmetn of Neurology

Prague, 110 00, Czechia

Location

Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken

Aarhus N, 8200, Denmark

Location

Rigshospitalet, Hukommelsesklinikken

København Ø, 2100, Denmark

Location

Terveystalo Tampere

Tampere, 33100, Finland

Location

CRST Oy

Turku, 20520, Finland

Location

Hopital Avicenne; Neurologie

Bobigny, 93009, France

Location

Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

Bron, 69677, France

Location

Hopital Gui de Chauliac; Neurologie

Montpellier, 34295, France

Location

Hopital Lariboisiere

Paris, 75475, France

Location

CHU Poitiers - Hopital La Miletrie

Poitiers, 86000, France

Location

Hopital Hautepierre; Centre dInvestigation Clinique

Strasbourg, 67098, France

Location

CHU Toulouse - La Grave

Toulouse, 31059, France

Location

Neurologische Praxis Dr. Andrej Pauls

München, 80331, Germany

Location

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

München, 81675, Germany

Location

Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie

Münster, 48149, Germany

Location

Steinwachs Klaus; Arztpraxis fur Neurologie u. Psychiatrie

Nuremberg, 90402, Germany

Location

Universitätsklinikum Rostock Zentrum für Nervenheilkunde

Rostock, 18147, Germany

Location

Universitätsklinikum Ulm; Klinik für Neurologie

Ulm, 89081, Germany

Location

Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz

Westerstede, 26655, Germany

Location

Forschungszentrum Ruhr

Witten, 58455, Germany

Location

Prince of Wales Hospital; Dept. of Medicine & Therapeutics

Hong Kong, Hong Kong

Location

Queen Mary Hospital, Division of Geriatric Medicine

Hong Kong, Hong Kong

Location

Semmelweis University; Department of Neurology

Budapest, 1083, Hungary

Location

Szabolcs-Szatmár-Bereg Megyei Kórházak - Jósa András Oktatókórház; Pszichiátria

Nyíregyháza, 4400, Hungary

Location

University of Szeged; Department of Psychiatry

Szeged, 6725, Hungary

Location

Szent Borbala Korhaz; Neurologiai es Stroke Osztaly

Tatabánya, 2800, Hungary

Location

Jávorszky Ödön Kórház, Neurológia és stroke osztály

Vác, 2600, Hungary

Location

Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica

Rome, Lazio, 00179, Italy

Location

Ospedale San Giovanni Calibita Fatebenefratell;Neurologia

Rome, Lazio, 00186, Italy

Location

Ente Ospedaliero Ospedali Galliera; Ambulatorio di Neurologia

Genoa, Liguria, 16128, Italy

Location

Casa di Cura Policlinico; Dipartimento di Scienze Neuroriabilitative

Milan, Lombardy, 20144, 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

Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; S.C. Geriatria

Perugia, Umbria, 06129, Italy

Location

Miyoshi Clinic of Neurology, Hananosato

Hiroshima, 728-0013, Japan

Location

National Hospital Organization Hiroshima-Nishi Medical Center

Hiroshima, 739-0696, Japan

Location

Rakuwakai Otowarehabilitation Hospital

Kyoto, 607-8113, Japan

Location

Mie University Hospital

Mie, 514-8507, Japan

Location

National Hospital Organization Matsumoto Medical Center

Nagano, 399-8701, Japan

Location

Saigata Medical Center

Niigata, 949-3193, Japan

Location

Katayama Medical Clinic

Okayama, 710-0813, Japan

Location

Tokyo Medical University Hospital

Tokyo, 160-0023, Japan

Location

Tokyo Metropolitan Geriatric Hospital

Tokyo, 173-0015, Japan

Location

National Center of Neurology and Psychiatry

Tokyo, 187-8551, Japan

Location

Vilnius University Hospital Santariskiu Clinic

Vilnius, 08661, Lithuania

Location

Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC

Culiacán, 80020, Mexico

Location

Hospital Uni; Dr. Jose E. Gonzalez

Monterrey, 64460, Mexico

Location

AVIX Investigación Clínica S.C

Monterrey, 64710, Mexico

Location

Hospital Universitario de Saltillo

Saltillo, 25000, Mexico

Location

Podlaskie Centrum Psychogeriatrii

Bialystok, 15-756, Poland

Location

NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek

Poznan, 61-853, Poland

Location

NEURO-CARE Sp. z o.o. Sp. Komandytowa

Siemianowice Śląskie, 41-100, Poland

Location

Przychodnia Specjalistyczna PROSEN

Warsaw, 01-231, Poland

Location

Centrum Medyczne NeuroProtect

Warsaw, 01-684, Poland

Location

Optimum

Warsaw, 01-785, Poland

Location

Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia

Amadora, 2720-276, Portugal

Location

Hospital Beatriz Angelo; Servico de Neurologia

Loures, 2674-514, Portugal

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

SBEI of HPI The 1st Moscow State Medical University n.a. I.M. Sechenov of MOH of RF

Moscow, 119021, Russia

Location

SHI City Psychoneurological Dispensary #7

Saint Petersburg, 190005, Russia

Location

Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department

Saint Petersburg, 194044, Russia

Location

City Clinical Hospital # 2 n.a. V.I. Razumovsky

Saratov, 410028, Russia

Location

University Medical Centre Maribor

Maribor, 2000, Slovenia

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Inha University Hospital

Incheon, 22332, South Korea

Location

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

KyungHee Medical Center

Seoul, 130-702, South Korea

Location

Ewha Womans University Mokdong Hospital; Dept of Neurology

Seoul, 158-710, South Korea

Location

Fundació ACE

BArcelon, Barcelona, 08034, Spain

Location

Hospital Universitari de Bellvitge; Servicio de Neurologia

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Sant Joan de Deu; Servicio de Neurología

Manresa, Barcelona, 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

Clinica Universitaria de Navarra; Servicio de Neurología

Pamplona, Navarre, 31008, Spain

Location

Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría

Salamaca, Salamanca, 37007, Spain

Location

Hospital General Universitario de Albacete; Servicio de Neurología

Albacete, Spain

Location

Hospital Vall d'Hebron; Servicio de Neurología

Barcelona, 08035, Spain

Location

Hospital Universitario de Burgos. Servicio de Neurología

Burgos, 09006, Spain

Location

Clinica Ruber, 4 planta; Servicio de Neurologia

Madrid, 28006, Spain

Location

Universitario de La Princesa; Servicio de Neurología

Madrid, 28006, Spain

Location

Hospital Universitario 12 de Octubre; Servicio de Neurologia

Madrid, 28041, Spain

Location

Hospital Regional Universitario Carlos Haya; Servicio de Neurologia

Málaga, 29010, Spain

Location

Hospital Universitario Virgen de Arrixaca; Servicio de Neurología

Murcia, Spain

Location

Hospital Universitario la Fe; Servicio de Neurologia

Valencia, 46026, Spain

Location

Servicio de Neurología Hospital Viamed Montecanal.

Zaragoza, 50012, 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

Karolinska Uni Hospital, Huddinge; Dept. of Geriatric Med

Stockholm, 14186, Sweden

Location

Universitäres Zentrum für Altersmedizin und Rehabilitation

Basel, 4002, Switzerland

Location

Hacettepe University School of Medicine; Neurology

Ankara, 06100, Turkey (Türkiye)

Location

Osmangazi University School of Medicine,Neurology Department

Eskişehir, 26480, Turkey (Türkiye)

Location

Istanbul University Istanbul School of Medicine; Neurology

Istanbul, 34093, Turkey (Türkiye)

Location

Ondokuz Mayis University School of Medicine; Neurology

Samsun, 55139, Turkey (Türkiye)

Location

Regional mental hospital; Department of psychiatry, psychology and sexology

Lviv, KIEV Governorate, 79021, Ukraine

Location

National Medical Academy of Postgraduate Education named after P.L.Shupik; Neurology Department #1

Kiev, 04112, Ukraine

Location

D.F.Chebotarev Institute of Gerontology NAMS;Depart of Age Physiology&Pathology of Nervous System

Kiev, 04114, Ukraine

Location

Royal Preston Hospital

Blackburn, PR2 9HT, United Kingdom

Location

Surrey and Borders NHS Foundation Trust; Brain Science Research Unit

Chertsey, KT16 0AE, United Kingdom

Location

Coventry and Warwickshire Partnership NHS Trust

Coventry, CV6 6NY, United Kingdom

Location

St George's Hospital

London, SW17 0QT, United Kingdom

Location

Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

Location

Campus for Ageing and Vitality

Newcastle upon Tyne, NE4 6BE, United Kingdom

Location

John Radcliffe Hospital

Oxford, OX3 9DU, 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

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: January 28, 2016
• First Posted: February 1, 2016
• Study Start: March 22, 2016
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: July 16, 2020
• Results First Posted: July 16, 2020

Record last verified: 2020-06

Locations

PL (6); DK (2); BE (1); LI (1); PT (2); IT (7); TU (4); ES (19); CO (2); HK (2); BU (2); AU (4); CA (9); DE (8); RU (7); SL (1); FR (7); GB (8); CH (1); SE (3); HU (5); US (66); UA (3); JP (10); FI (2); ME (4); CR (1); KR (6); CZ (2)