Clinical Trial Details

NCT ID: NCT02670083
Date Last Changed: September 25, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study of Crenezumab and Placebo to evaluate Alzheimer's Disease, Mild Alzheimer's Disease (AD)

Research Study 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

Purpose

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.

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
50 to 85 Years
Overall Status
Recruiting
Lead Sponsor
Hoffmann-La Roche
Duration
53 Months
Facility Type
N/A
Compensation

Eligibility

All ages 50 Years to 85 Years

Inclusion Criteria:

  • 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

  • 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

Exclusion Criteria:

  • 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

  • Presence of significant cerebral vascular pathology as assessed by MRI central reader

  • Unstable or clinically significant cardiovascular, kidney or liver disease (e.g., myocardial infarction)

  • 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

Site Locations (156)

Country State City Zip Facility and Contact
United States Arizona Phoenix 85013 Barrow Neurological Institute
United States Arizona Phoenix 85020 Banner Alzheimer's Institute
United States California Long Beach 90806 Collaborative Neuroscience Network Inc.
United States California Los Alamitos 90720 Pharmacology Research Institute
United States California Los Angeles 90025 UCLA Medical Center, Department of Neurology
United States California Los Angeles 90033 USC Keck School Of Medicine
United States California Newport Beach 92660 Pharmacology Research Inst
United States California Newport Beach 92663 Shankle Clinic
United States California Palo Alto 94304 Stanford Univ Medical Center
United States California Sacramento 95817 University of California, Davis; Alzheimers Disease Center, Department of Neurology
United States California San Francisco 94143 UCSF - Memory and Aging Center
United States California Santa Monica 90025 Neurological Research Inst
United States California Sebastopol 95472 North Bay Neuro Science Institute
United States Connecticut Danbury 06810-4088 Associated Neurologists PC - Danbury
United States Connecticut New Haven 06510 Yale University School Of Medicine
United States Florida Bradenton 34205 Bradenton Research Center
United States Florida Delray Beach 33445 Brain Matters Research, Inc.
United States Florida Hialeah 33016 Galiz Research, LLC
United States Florida Merritt Island 32952 Merritt - Island Medical Research
United States Florida Miami 33137 Miami Jewish Health Systems
United States Florida Orlando 32801 CNS Healthcare
United States Florida Port Orange 32127 Progressive Medical Research
United States Florida Tampa 33613 Johnnie B. Byrd Sr. Alzheimer's Center & Research Institute
United States Florida Tampa 33613 Stedman Clinical Trials, LLC
United States Florida The Villages 32162 Compass Research
United States Georgia Decatur 30033 NeuroStudies.net, LLC
United States Illinois Elk Grove Village 60007 Alexian Brothers Neurosci Inst
United States Illinois Springfield 62702 Southern Illinois University, School of Medicine
United States Kansas Lenexa 66214 MidAmerica Neuroscience Institute
United States Maine Scarborough 04074 MMP Neurology
United States Mississippi Flowood 39232 Precise Research Centers
United States New Jersey Springfield 07081 The Cognitive and Research Center of New Jersey
United States New Jersey West Long Branch 07764 Neurology Specialists of Monmouth County, PA
United States New York Albany 12206 Albany Medical Faculty Physicians COmmunity Division. The Neurology Group
United States New York Albany 12298 Neurological Associates of Albany, PC
United States New York Patchogue 11772 South Shore Neurologic Associates P.C.
United States New York Williamsville 14221 Dent Neurological Institute
United States North Carolina Charlotte 28211 Behavioral Health Research
United States North Carolina Greensboro 27401 Guilford Neurologic Associates
United States Ohio Shaker Heights 44122 Insight Clinical Trials LLC
United States Oklahoma Oklahoma City 73112 Oklahoma Clinical Research
United States Oklahoma Oklahoma City 73116 Cutting Edge Research Group
United States Oklahoma Tulsa 74104 Tulsa Clinical Research LLC
United States Oregon Portland 97210 Summit Research Network Inc.
United States Pennsylvania Philadelphia 19107 Drexel Univ College of Med; Clinical Research Group
United States Texas Dallas 75231 Texas Alzheimer's and Memory Disorders
United States Virginia Norfolk 23510 Sentara Medical Group
United States Wisconsin Milwaukee 53226 Medical College of Wisconsin
Australia South Australia Woodville 5011 The Queen Elizabeth Hospital; Neurology
Australia Victoria Caulfield 3162 Caulfield Hospital; Aged Psychiatry Research Unit
Australia Victoria Heidelberg West 3081 Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
Australia Western Australia West Perth 6005 Neurodegenerative Disorders Research; Neurology
Austria Linz 4021 Konventhospital Barmherzige Brüder; Neurologie I
Bulgaria Sofia 1407 Tokuda Hospital; Department of Neurology
Bulgaria Sofia 1431 Alexandrovska hospital; Neurology Department
Canada British Columbia Victoria V8R 1J8 Vancouver Island Health Authority
Canada Ontario Ottawa K1N 5C8 Bruyere Continuing Care
Canada Ontario Peterborough K9H 2P4 Kawartha Regional Memory Clinic
Canada Ontario Toronto M4G 3E8 The Centre for Memory and Aging
Canada Ontario Toronto M5T 2S8 Toronto Western Hospital
Canada Ontario Woodstock N4S 5P5 Devonshire Clinical Research Inc.
Canada Quebec Quebec City G1J 1Z4 CHA Hopital de I enfant-Jesus
Costa Rica San José 10101 Hospital Clínica Biblica
Croatia Zagreb 10000 Clinical Hospital Centre Zagreb;Clinic for Neurology
Czechia Hradec Králové 500 05 Charles University, Medical faculty, Hradec Kralove ;Department of Neurology
Czechia Praha 110 00 General Teaching Hospital, Departmetn of Neurology
Finland Turku 20520 CRST Oy
France Bobigny 93009 Hopital Avicenne; Neurologie
France Bron 69677 Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
France Marseille 13005 CHU de la Timone - Hopital d Adultes; Service de Neurologie
France Paris 75475 Hopital Lariboisiere
France Poitiers 86000 CHU Poitiers - Hopital La Miletrie
France Toulouse 31059 CHU Toulouse - La Grave
Germany München 80331 Neurologische Praxis Dr. Andrej Pauls
Germany München 81675 Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie
Germany Münster 48149 Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie
Germany Nürnberg 90402 Steinwachs Klaus; Arztpraxis fur Neurologie u. Psychiatrie
Germany Rostock 18147 Universitätsklinikum Rostock Zentrum für Nervenheilkunde
Germany Ulm 89081 Universitätsklinikum Ulm; Klinik für Neurologie
Germany Witten 58455 Forschungszentrum Ruhr
Hong Kong Hong Kong Prince of Wales Hospital; Dept. of Medicine & Therapeutics
Hong Kong Hong Kong Queen Mary Hospital, Division of Geriatric Medicine
Hong Kong Tuen Mun Tuen Mun Hospital; Medicine & Geriatrics
Hungary Budapest 1083 Semmelweis University; Department of Neurology
Hungary Esztergom 2500 Vaszary Kolos Korhaz; Neurology
Hungary Nyíregyháza 4400 Szabolcs-Szatmár-Bereg Megyei Kórházak - Jósa András Oktatókórház; Pszichiátria
Hungary VAC 2600 Jávorszky Ödön Kórház, Neurológia és stroke osztály
Italy Calabria Lamezia Terme (CZ) 88046 Azienda Sanitaria Provinciale Di Catanzaro-P.O. Giovanni Paolo II; Centro Regionale Di Neurogenetica
Italy Lazio Roma 00179 Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica
Italy Liguria Genova 16128 Ente Ospedaliero Ospedali Galliera; Ambulatorio di Neurologia
Italy Liguria Genova 16132 Irccs Aou San Martino - Ist; Dipartimento Di Medicina Interna
Italy Lombardia Milano 20148 Ospedale S. Maria Nascente; Fondazione Don Gnocchi; Dip. Neurologia Riabilitativa
Italy Lombardia Passirana 20017 Ospedale Casati Passirana di Rho; Centro Regionale Alzheimer
Italy Umbria Perugia 06129 Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; S.C. Geriatria
Japan Iwate 020-8505 Iwate Medical University Hospital
Japan Kagawa 760-8557 Kagawa Prefectural Central Hospital
Japan Kyoto 607-8113 Rakuwakai Otowarehabilitation Hospital
Japan Mie 514-8507 Mie University Hospital
Japan Osaka 558-8558 Osaka General Medical Center
Japan Tokyo 145-0065 Ebara Hospital
Japan Tokyo 158-8531 Kanto Central Hospital
Japan Tokyo 160-0023 Tokyo Medical University Hospital
Japan Tokyo 169-0073 Shinjuku Research Park Clinic
Japan Tokyo 173-0015 Tokyo Metropolitan Geriatric Hospital
Japan Tokyo 187-8551 National Center of Neurology and Psychiatry
Korea, Republic of Incheon 22332 Inha University Hospital
Korea, Republic of Seoul 05030 Konkuk University Medical Center
Korea, Republic of Seoul 05505 Asan Medical Center
Lithuania Vilnius 08661 Vilnius University Hospital Santariskiu Clinic
Mexico Culiacan 80020 Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC
Poland Gdansk 80-462 KOPERNICUS Podmiot Leczniczy Sp. z o.o.
Poland Katowice 40-749 NEURO-CARE Gabriela Kłodowska
Poland Krakow 31-505 Centrum Neurologii Klinicznej
Poland Poznań 60-848 Clinical Research Center Sp. z o.o. MEDIC-R Spółka Komandytowa
Poland Warsaw Centrum Medyczne NeuroProtect
Poland Warszawa 01-231 Przychodnia Specjalistyczna PROSEN
Poland Warszawa 01-785 Optimum
Poland Łódź 92-216 Uniwersytet Medyczny w Lodzi Katedra Psychiatrii
Portugal Amadora 2720-276 Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia
Russian Federation Kazan 420021 Republican clinical hospital of regenerative treatment of Ministry of Health of Tatarstan republic
Russian Federation Kazan 420101 State autonomous institution of healthcare Inter-regional clinical and diagnostic center
Russian Federation Moscow 115522 Institution of RAMS (Mental Health Research Center of RAMS)
Russian Federation Moscow 119021 SBEI of HPI The 1st Moscow State Medical University n.a. I.M. Sechenov of MOH of RF
Russian Federation Saratov 410028 City Clinical Hospital # 2 n.a. V.I. Razumovsky
Russian Federation St Petersburg 190005 SHI City Psychoneurological Dispensary #7
Russian Federation St. Petersburg 194044 Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department
Slovenia Maribor 2000 University Medical Centre Maribor
Spain Barcelona BArcelon 08034 Fundació ACE
Spain Barcelona L'Hospitalet de Llobregat 08907 Hospital Universitari de Bellvitge; Servicio de Neurologia
Spain Barcelona Manresa Hospital Sant Joan de Deu; Servicio de Neurología
Spain Barcelona Sant Cugat del Valles 8195 Hospital General De Catalunya; Servicio de Neurologia
Spain Barcelona Terrasa 08221 Hospital Mutua De Terrasa; Servicio de Neurologia
Spain Caceres Plasencia 10600 Hospital Virgen del Puerto. Servicio de Neurología
Spain Navarra Pamplona 31008 Clinica Universitaria de Navarra; Servicio de Neurología
Spain Burgos 09006 Hospital Universitario de Burgos. Servicio de Neurología
Spain Lugo Hospital Lucus Augusti; Servicio de Neurología
Spain Madrid 28006 Clinica Ruber, 4 planta; Servicio de Neurologia
Spain Madrid 28006 Universitario de La Princesa; Servicio de Neurología
Spain Malaga 29010 Hospital Regional Universitario Carlos Haya; Servicio de Neurologia
Spain Murcia Hospital Universitario Virgen de Arrixaca; Servicio de Neurología
Spain Zaragoza 50012 Servicio de Neurología Hospital Viamed Montecanal.
Sweden Malmoe SE-20502 Skånes Universitetssjukhus Malmö, Minneskliniken
Turkey Ankara 06100 Hacettepe University School of Medicine; Neurology
Turkey Eskişehir 26480 Osmangazi University School of Medicine,Neurology Department
Turkey Istanbul 34093 Istanbul University Istanbul School of Medicine; Neurology
Turkey Samsun 55139 Ondokuz Mayis University School of Medicine; Neurology
Ukraine Kiev Governorate Lviv 79021 Regional mental hospital; Department of psychiatry, psychology and sexology
Ukraine Kiev 04112 National Medical Academy of Postgraduate Education named after P.L.Shupik; Neurology Department #1
Ukraine Kiev 04114 D.F.Chebotarev Institute of Gerontology NAMS;Depart of Age Physiology&Pathology of Nervous System
United Kingdom Chertsey KT16 0AE Surrey and Borders NHS Foundation Trust; Brain Science Research Unit
United Kingdom Coventry CV6 6NY Coventry and Warwickshire Partnership NHS Trust
United Kingdom London SW17 0QT St George's Hospital
United Kingdom London W6 8RF Charing Cross Hospital
United Kingdom Manchester M13 9WL Manchester Royal Infirmary
United Kingdom Oxford OX3 9DU John Radcliffe Hospital
United Kingdom Preston PR2 9HT Royal Preston Hospital

Contact

Reference Study ID Number: BN29552 www.roche.com/about_roche/roche_worldwide.htm
888-662-6728 (U.S. and Canada)
E-mail:

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