Clinical Trial Details

NCT ID: NCT02484547
Date Last Changed: October 1, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study of Aducanumab (BIIB037) and Placebo to evaluate Alzheimer's Disease

Research Study Title

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects With Early Alzheimer's Disease

Purpose

The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) [ADCS-ADL-MCI].

To Learn more

Recruitment Details

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

Eligibility

All ages 50 Years to 85 Years

Key Inclusion Criteria:

  • Must meet all of the following clinical criteria for MCI due to AD or mild AD and must have:

  • A Clinical Dementia Rating (CDR)-Global Score of 0.5.

  • Objective evidence of cognitive impairment at screening

  • An MMSE score between 24 and 30 (inclusive)

  • Must have a positive amyloid Positron Emission Tomography (PET) scan

  • Must consent to apolipoprotein E (ApoE) genotyping

  • If using drugs to treat symptoms related to AD, doses must be stable for at least 8 weeks prior to screening visit 1

  • Must have a reliable informant or caregiver

Key Exclusion Criteria:

  • Any medical or neurological condition (other than Alzheimer's Disease) that might be a contributing cause of the subject's cognitive impairment

  • Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year

  • Clinically significant unstable psychiatric illness in past 6 months

  • History of unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to Screening

  • Indication of impaired renal or liver function

  • Have human immunodeficiency virus (HIV) infection

  • Have a significant systematic illness or infection in past 30 days

  • Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities

  • Any contraindications to brain magnetic resonance imaging (MRI) or PET scans

  • Alcohol or substance abuse in past 1 year

  • Taking blood thinners (except for aspirin at a prophylactic dose or less)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Site Locations (180)

Country State City Zip Facility and Contact
United States Alabama Birmingham 35233 University of Alabama at Birmingham
205-996-3679

David Geldmacher
Principal Investigator
United States Arizona Phoenix 85006 Banner Alzheimer's Institute
623-832-6500

David Weidman
Principal Investigator
United States Arizona Phoenix 85013 Xenoscience Inc.
602-274-9500

Stephen Flitman
Principal Investigator
United States Arizona Sun City 85351 Banner Sun Health Research Institute
623-832-6530

Edward Zamrini
Principal Investigator
United States California Irvine 92607 Institute for Memory Impairments
949-824-3250

Aimee Pierce
Principal Investigator
United States California Long Beach 85013 Renewal Behavioral Health
562-426-5222

Laja Ibraheem
Principal Investigator
United States California Los Angeles 90033 USC Keck School of Medicine
323-442-7600

Lon Schneider
Principal Investigator
United States California Newport Beach 92663 Hoag Memorial Hospital Presbyterian
949-478-8858

William Shankle
Principal Investigator
United States California Oceanside 92056 Excell Research, Inc.
760-758-2222

Sheryy Soefje
Principal Investigator
United States California Oxnard 93030 Pacific Neuroscience Medical Group
805-278-4148

James Sutton
Principal Investigator
United States California Redlands 92354 Anderson Clinical Research
909-792-9007

Donald Anderson
Principal Investigator
United States California San Diego 92103 Pacific Research Network
619-294-4302

Stephen Thein
Principal Investigator
United States California San Diego 92103 University of California San Diego Medical Center
619-543-6102

James Lohr
Principal Investigator
United States California San Francisco 94114 California Pacific Medical Center
415-600-5555

Alireza Atri
Principal Investigator
United States California Santa Ana 92705 Syrentis Clinical Research
714-542-3008

John Duffy
Principal Investigator
United States California Santa Rosa 95403 St Joseph Heritage Healthcare
707-521-3814

Marc Bernstein
Principal Investigator
United States California Stanford 94305 Stanford University Medical Center
650-725-6563

Sharon Sha
Principal Investigator
United States Colorado Aurora 80045 University Of Colorado Denver
303-724-7863

Jonathan Woodcock
Principal Investigator
United States Colorado Thornton 80233 IMMUNOe International Research Centers
303-771-9000

Ronald Murray
Principal Investigator
United States Connecticut Fairfield 06824 Associated Neurologists of Southern Connecticut, PC
203-333-1151

Dario Zagar
Principal Investigator
United States Connecticut New Haven 06520 Yale University School Of Medicine
203-764-8100

Christopher Van Dyck
Principal Investigator
United States Connecticut Norwalk 06851 Research Center for Clinical Studies, Inc.
203-838-0070

Bart Sloan
Principal Investigator
United States Florida Atlantis 33462 JEM Research Institute
561-968-2933

Mark Goldstein
Principal Investigator
United States Florida Boca Raton 33431 Florida Atlantic University
561-297-4806

James Galvin
Principal Investigator
United States Florida Bradenton 34205 Bradenton Research Center, Inc.
941-708-0005

William McElveen
Principal Investigator
United States Florida Brooksville 34601 Meridien Research
352-597-7578

Kelli Max
Principal Investigator
United States Florida Deerfield Beach 33064 Quantum Laboratories Inc.
954-786-7331

Jose De La Gandara
Principal Investigator
United States Florida Hollywood 33021 Infinity Clinical Research, LLC
954-981-3850

Harvey Schwartz
Principal Investigator
United States Florida Jacksonville 32224 Mayo Clinic in Florida
904-953-7103

Neill Graff-Radford
Principal Investigator
United States Florida Ocala 34471 Renstar Medical Research
352-629-5800

Jay Rubin
Principal Investigator
United States Florida Orlando 32801 Clinical Neuroscience Solutions, Inc.
407-425-5100

Linda Harper
Principal Investigator
United States Florida Tampa 33609 Axiom Clinical Research of Florida
813-353-9613

Susan Steen
Principal Investigator
United States Georgia Atlanta 30329 Emory University Cognitive Neurology Clinic & ADRC
404-727-7220

Allan Levey
Principal Investigator
United States Georgia Columbus 31909 Medical Research Health and Education Foundation, Inc
706-653-8455

Jonathan Liss
Principal Investigator
United States Georgia Decatur 30033 NeuroStudies.net, LLC
404-475-0552

Marshall Nash
Principal Investigator
United States Indiana Indianapolis 46256 Josephson, Wallack, Munshower Neurology, PC
317-537-6060

Kristi George
Principal Investigator
United States Massachusetts Belmont 02478 McLean Hospital
617-855-3622

Brent Forester
Principal Investigator
United States Massachusetts Newton 05201 Boston Center for Memory
617-699-6927

Paul Solomon
Principal Investigator
United States Mississippi Hattiesburg Hattiesburg Clinic, PA
601-268-5620

Ronald Schwartz
Principal Investigator
United States Nevada Las Vegas 89106 Cleveland Clinic Lou Ruvo Center for Brain Health
702-483-6026

Charles Bernick
Principal Investigator
United States New Hampshire Portsmouth 03801 ActivMed Practices & Research
978-372-7252

Marc Shay
Principal Investigator
United States New Jersey Lawrenceville 08648 AdvanceMed Research
609-895-0735

Arnold Witte
Principal Investigator
United States New York Latham 12110 Empire Neurology, PC
518-785-1000

Keith Edwards
Principal Investigator
United States New York New York 10021 Weill Cornell Medical College-New York Presbyterian Hospital
212-746-2441

Michael Lin
Principal Investigator
United States New York New York 10029 Mount Sinai School of Medicine
347-326-2178

Amy Aloysi
Principal Investigator
United States North Carolina Winston-Salem 27103 PMG Research of Winston-Salem, LLC
336-794-8165

Giles Crowell
Principal Investigator
United States North Carolina Winston-Salem 27103 Wake Forest Baptist Health
336-713-8558

Kaycee Sink
Principal Investigator
United States Ohio Dublin 43017 Ohio State University Medical Center
614-293-8531

Douglas Scharre
Principal Investigator
United States Pennsylvania Allentown 18104 Lehigh Center for Clinical Research, LLC
610-820-0342

Paul Gross
Principal Investigator
United States Pennsylvania Philadelphia 19104 Penn Memory Center
Grace Stockbower
215-746-3949

David Wolk
Principal Investigator
United States Rhode Island Providence 02903 Rhode Island Hospital
401-444-6440

Brian Ott
Principal Investigator
United States South Carolina North Charleston 29406-6076 Roper St. Francis Healthcare
843-724-2302

Jacobo Mintzer
Principal Investigator
United States Texas Austin 78757 Senior Adult Specialty Research
512-407-8628

Jaron Winston
Principal Investigator
United States Texas Houston 77074 Clinical Trial Network
713-484-6947

Djamchid Lotfi
Principal Investigator
United States Utah Salt Lake City 84132 University of Utah Health Sciences Center
801-261-8950

Richard King
Principal Investigator
United States Vermont Bennington 05201 Clinical Neuroscience Research Association, Inc
802-447-1409

Cynthia Murphy
Principal Investigator
United States Washington Seattle 98195 University of Washington Medical Center
206-221-2930

Suman Jayadev
Principal Investigator
United States Washington Spokane 99202 Northwest Neurological, PLLC
509-343-3710

David Greeley
Principal Investigator
Belgium Brugge 8000 AZ Sint-Jan Brugge
Belgium Bruxelles 1090 Universitair Ziekenhuis Brussel
+3224763739

Versijpt
Principal Investigator
Belgium Fraiture-en-Condroz 4557 Centre Neurologique & de Réadaptation Fonctionnelle
085/519128

Guillaume
Principal Investigator
Belgium Gent 9000 Universitair Ziekenhuis Gent
Belgium Kortrijk 8500 AZ Groeninge - Campus Kennedylaan
Belgium Leuven 3000 UZ Leuven
+3216344280

Rik Vandenberghe
Principal Investigator
Belgium Roeselare 8800 AZ Delta
+32 51 23 74 41

Dr. Philip Bourgeois
Principal Investigator
Canada British Columbia Kamloops Health Research.
Canada British Columbia West Vancouver Health Research
Canada Nova Scotia Halifax B3S 1M7 True North Clinical Research - Halifax Inc.
Canada Nova Scotia Kentville B4N 4K9 True North Clinical Research Kentville, Inc
Canada Ontario Burlington L7M 4Y1 JBN Medical Diagnostic Services Inc.
Canada Ontario London N6C 5J1 St. Joseph's HC- Parkwood Institute
Canada Ontario Ottawa K1N 5C8 Bruyere Continuing Care
Canada Ontario Peterborough K9H 2P4 Kawartha Regional Memory Clinic
Canada Ontario Toronto M5T 2S8 Toronto Western Hospital
Canada Quebec Gatineau J8T 8J1 Recherches Neuro-Hippocampe Inc.
Canada Quebec Greenfield Park J4V 2J2 Recherche Sepmus, Inc.
Canada Quebec Sherbrooke J1H 1Z1 DIEX Recherche Sherbrooke Inc.
Canada Quebec Verdun H4H 1R3 Douglas Hospital Research Centre
Finland Helsinki 00100 Terveystalo Kamppi
Finland Kuopio 70210 Itä-Suomen yliopisto, Aivotutkimusyksikkö
+358405678433

Merja Hallikainen
Principal Investigator
Finland Turku 20520 CRST, Clinical Research Services Turku
France Bouches-du-Rhône Marseille 13385 Hôpital de la Timone
0033491385928

Ceccaldi
Principal Investigator
France Haute Garonne Toulouse cedex 9 31059 CHU de Toulouse - Hôpital Purpan
05.61.77.76.86

Jeremie Pr Pariente
Principal Investigator
France Haute Garonne Toulouse 31052 Centre de Recherche Clinique du Gérontopôle - Cité de la Santé
+33 5 61777973

Vellas
Principal Investigator
France Herault Montpellier 34295 Hôpital Gui de Chauliac
00 33 4 67 33 79 57

Dr. Karim Bennys
Principal Investigator
France Ille et Vilaine Rennes cedex 09 35033 CHU Rennes - Hopital Pontchaillou
France Loire Atlantique Nantes cedex 1 44093 CHU Nantes - Hopital Nord Laënnec
France Nord Lille Cedex 59037 Hopital Roger Salengro - CHU Lille
+33 3 20 66 67 28

Florence Pasquier
Principal Investigator
France Rhone Villeurbanne 69100 Hôpital des Charpennes
04.72.43.25.01

Pr Krolak-Salmon
Principal Investigator
France Paris 75010 Hôpital Fernand Widal
+33149958494

Jacques Hugon
Principal Investigator
Germany Baden Wuerttemberg Guenzburg 89312 Bezirkskrankenhaus Guenzburg
Germany Baden Wuerttemberg Mannheim 68165 ISPG - Institut fuer Studien zur Psychischen Gesundheit
Germany Baden Wuerttemberg Ulm 89078 Nervenfachaerztlichen Gemeinschaftspraxis Ulm
Germany Baden Wuerttemberg Ulm 89081 Universitaetsklinikum Ulm
Germany Bayern Bayreuth 95445 Klinik Hohe Warte Bayreuth
Germany Bayern Muenchen 81377 Institut fuer Schlaganfall- und Demenzforschung (ISD)
Germany Bayern Muenchen 81675 Klinikum rechts der Isar der TU Muenchen
Germany Bayern Unterhaching 82008 Neuropraxis Muenchen Sued
Germany Bayern Wenzenbach 93173 Praxis Dr. Kluenemann
Germany Hessen Erbach 64711 Neuro Centrum Odenwald
Germany Nordrhein Westfalen Bielefeld 33647 Schwerpunktpraxis fuer Neurologie, Psychiatrie und Klinische Studien
Germany Nordrhein Westfalen Duesseldorf 40629 Universitaetsklinikum Duesseldorf AoeR
Germany Nordrhein Westfalen Muenster 48149 Universitaetsklinikum Muenster
Germany Nordrhein Westfalen Siegen 57076 Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung
Germany Rheinland Pfalz Mainz 55131 Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Germany Sachsen Chemnitz 09131 Klinikum Chemnitz gGmbH
Germany Thueringen Altenburg 04600 Klinikum Altenburger Land GmbH
Germany Berlin 10629 emovis GmbH
Germany Berlin 12099 Neurologie im Tempelhofer Hafen
Isabella Lemonnier
+49 30 755 123 2456
Italy Biella Ponderano 13875 Ospedale degli Infermi
Italy Lecce Tricase 73039 Azienda Ospedaliera Card. G. Panico
Italy Milano Monza 20052 ASST di Monza
Italy Milano 20133 Fondazione IRCCS Istituto Neurologico Carlo Besta
Italy Palermo 90100 Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Italy Perugia 06156 Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
Italy Roma 00179 Fondazione Santa Lucia IRCCS
Italy Roma 00185 Umberto I Pol. di Roma-Università di Roma La Sapienza
Japan Aichi-Ken Obu-shi 474-8511 Research Site
Japan Ehime-Ken Toon-shi 791-0295 Research Site
Japan Fukuoka-Ken Fukuoka-shi 814-0180 Research Site
Japan Hiroshima-Ken Otake-shi 739-0696 Research Site
Japan Hyogo-Ken Amagasaki-shi 660-8511 Research Site
Japan Hyogo-Ken Himeji-shi 672-8043 Research Site
Japan Hyogo-Ken Kobe-shi 650-0047 Research Site
Japan Mie-Ken Tsu-shi 514-8507 Research Site
Japan Nagasaki-Ken Nishisonogi-gun 851-2103 Research Site
Japan Oita-Ken Yufu-shi 879-5593 Research Site
Japan Okayama-Ken Kurashiki-shi 710-0813 Research Site
Japan Okayama-Ken Okayama-shi 703-8265 Research Site
Japan Okayama-Ken Tsukubo-Gun 701-0304 Research Site
Japan Osaka-Fu Osaka-shi 530-0001 Research Site
Japan Osaka-Fu Osaka-shi 530-0005 Research Site
Japan Osaka-Fu Osaka-shi 545-8586 Research Site
Japan Osaka-Fu Osaka-shi 553-0003 Research Site
Japan Osaka-Fu Sennan-shi 590-0503 Research Site
Japan Osaka-Fu Suita-shi 565-0871 Research Site
Japan Osaka-Fu Toyonaka-Shi 560-0004 Research Site
Japan Shizuoka-Ken Iwata-shi 438-0043 Research Site
Japan Shizuoka-Ken Shizuoka-shi 420-8688 Research Site
Japan Shizuoka-Ken Shizuoka-shi 424-8636 Research Site
Netherlands Amsterdam 1081 GM Alzheimer Research Center
Kim Verheul
+31 20 301 71 70
Netherlands Breda 4818 CK Amphia Ziekenhuis
076 595 4127

Dr. A. van Norden
Principal Investigator
Netherlands Rotterdam 3015 CE Erasmus Medisch Centrum
Poland Bialystok 15-732 Podlaskie Centrum Psychogeriatrii
Poland Bydgoszcz 85-796 PALLMED Sp. z o.o.
Poland Gdansk 80-803 COPERNICUS Podmiot Leczniczy Sp. z o. o.,
Poland Gdansk Uniwersyteckie Centrum Kliniczne
Poland Katowice 40-650 Novo-Med Zielinski i wspolnicy Sp. j.
Poland Katowice 40-749 Neuro-Care Site Management Organization Gabriela Klodowska-Duda
Poland Lodz 92-216 SPZOZ Centralny Szpital Kliniczny UM w Lodzi
Poland Lubin 59-300 Centrum Diagnostyczno - Terapeutyczne "MEDICUS" Sp.z o.o.
Poland Lublin 20-950 Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Poland Plewiska 62-064 Neurologiczny NZOZ Centrum Leczenia SM
Poland Poznan 61-853 NZOZ "NEURO-KARD", "Ilkowski i Partnerzy" Sp. Partn. Lek.
Poland Rzeszow 35-055 Centrum Medyczne Medyk
Poland Sopot 81-855 NZOZ "SENIOR" Poradnia Psychogeriatryczna
Poland Szczecin 70-111 Osrodek Badan Klinicznych EUROMEDIS
Poland Warszawa 01-697 mMED Maciej Czarnecki
Poland Warszawa 02-507 Centralny Szpital Kliniczny MSW w Warszawie
Spain Alicante Elche 3203 Hospital General Universitario de Elche
Spain Barcelona Manresa 08243 ALTHAIA Hospital Sant Joan de Deu
Spain Córdoba Cordoba 14011 Hospital Universitario Reina Sofía
Spain Navarra Pamplona 31008 Clinica Universidad de Navarra
+34 948 255400 ext. 3595

Mario Riverol
Principal Investigator
Spain Vizcaya Bilbao 48013 Hospital de Basurto
Spain Barcelona 08003 Hospital del Mar
Spain Barcelona 08028 Hospital Universitari Quiron Dexeus
Spain Barcelona 8907 Hospital Universitari de Bellvitge
Spain Lleida 25198 Hospital Universitari Arnau de Vilanova
Spain Sevilla 41009 Hospital Universitario Virgen Macarena
Sweden Malmö 20502 Skånes Universitetssjukhus, Malmö
Sweden Mölndal 43141 Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus
Sweden Stockholm 14186 Karolinska Universitetssjukhuset, Huddinge
+46 858585468

Niels Andreasen
Principal Investigator
Sweden Uppsala 75185 Akademiska Sjukhuset
Switzerland Basel 4025 Universitären Psychiatrischen Kliniken Basel (UPK)
Switzerland Bern Inselspital - Universitaetsspital Bern
Switzerland Biel/Bienne 2502 Medizinisches Zentrum MZB Biel
Switzerland Geneve 14 1211 Hôpitaux Universitaires de Genève - HUG
Switzerland Lausanne CH-1011 Centre Hospitalier Universitaire Vaudois
+41 21 314 97 19

Prof. Jean-Francois Demonet
Principal Investigator
Switzerland Lugano 6903 Ospedale Civico
Switzerland Schlieren 8952 Institut fuer Regenerative Medizin (IREM) der Universitaet Zuerich, Zentrum fuer Praevention und Demenztherapie

Contact

Aducanumab Global Clinical Trial Center

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