Clinical Trial Details

NCT ID: NCT02477800
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, Early

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
51 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 (173)

Country State City Zip Facility and Contact
United States Arizona Phoenix 85013 St. Joseph's Hospital and Medical Center
602-406-6262

Jiong Shi
Principal Investigator
United States Arizona Tucson 85718 Center for Neurosciences
520-320-2147

Michael Badruddoja
Principal Investigator
United States California Fullerton 92835 Neurology Center of North Orange County
714-879-7200

Anthony Ciabarra
Principal Investigator
United States California Laguna Hills 92653 Senior Clinical Trials, Inc.
949-588-0909

Robert Feldman
Principal Investigator
United States California Los Angeles 90095 University of California - Los Angeles
310-794-6191

Sarah Kremen
Principal Investigator
United States California San Francisco 94158 UCSF - Memory and Aging Center
415-476-8333

Adam Boxer
Principal Investigator
United States California Sherman Oaks 91403 California Neuroscience Research Medical Group Inc.
818-990-2671

Thomas Shiovitz
Principal Investigator
United States California Simi Valley 93065 Southern California Research LLC
818-631-7489

Brock Summers
Principal Investigator
United States Connecticut New Haven 06510 Institute for Neurodegenerative Disorders
203-401-4300

David Russell
Principal Investigator
United States District of Columbia Washington, D.C. 20057 Georgetown University Hospital
202-687-7337

Raymond Turner
Principal Investigator
United States Florida Delray Beach 33445 Brain Matters Research, Inc.
561-374-8461

Mark Brody
Principal Investigator
United States Florida Fort Myers 33912 Neuropsychiatric Research Center of Southwest Florida
239-939-7777

Frederick Schaerf
Principal Investigator
United States Florida Jacksonville 32216 Jacksonville Center for Clinical Research
904-730-0101

Erin Doty
Principal Investigator
United States Florida Miami 33136 University of Miami
305-243-0184

Barry Baumel
Principal Investigator
United States Florida Miami 33137 Miami Jewish Health Systems
305-751-8626

Marc Agronin
Principal Investigator
United States Florida Orlando 32806 Compass Research Main
407-426-9299

Craig Curtis
Principal Investigator
United States Florida Palm Beach Gardens 33410 Palm Beach Neurological Center
561-282-5541

Michael Tuchman
Principal Investigator
United States Florida Tampa 33613 Stedman Clinical Trials, LLC
813-971-8311

Mary Stedman
Principal Investigator
United States Florida Tampa 33616 USF Health Byrd Institute
813-974-4355

Amanda Smith
Principal Investigator
United States Florida Tampa 33634 Meridien Research
813-877-8839

Cynthia Huffman
Principal Investigator
United States Florida The Villages 32162 Compass Research Main
352-261-0901

David Subich
Principal Investigator
United States Florida West Palm Beach 33407 Premiere Research Institute
561-845-0500

Walter Martinez
Principal Investigator
United States Florida Weston 33331 Cleveland Clinic Florida - Weston
954-659-5670

Po-Heng Tsai
Principal Investigator
United States Illinois Elk Grove Village 60007 Alexian Brothers Neurosciences Institute
847-593-8553

Concetta Forchetti
Principal Investigator
United States Illinois Park Ridge 60068 Advocate Lutheran General Hospital
847-720-6464

Darren Gitelman
Principal Investigator
United States Indiana Fort Wayne 46804 Fort Wayne Neurological Center
260-436-3991

James Stevens
Principal Investigator
United States Indiana Indianapolis 46202 Indiana University School of Medicine
317-963-7411

Martin Farlow
Principal Investigator
United States Kansas Kansas City 66160 University of Kansas Medical Center Research Institute, Inc.
913-588-0555

Jeffrey Burns
Principal Investigator
United States Kansas Wichita 67214 Via Christi Research, a division of Via Christi Hospitals Wichita, Inc.
316-291-4774

Paul Murphy
Principal Investigator
United States Kentucky Lexington 40503 Baptist Health Lexington
859-260-4330

Gregory Cooper
Principal Investigator
United States Massachusetts Boston 02115 Brigham & Women's Hosp End/Dbt
617-732-8085

Scott McGinnis
Principal Investigator
United States Massachusetts Boston 02215 Beth Israel Deaconess Medical Center
617-667-5553

Henry Querfurth
Principal Investigator
United States Massachusetts Methuen 01844 ActivMed Practices & Research
978-655-7155

Michael McCartney
Principal Investigator
United States Massachusetts Plymouth 02360 Donald S. Marks, M.D., P.C.
508-746-5060

Donald Marks
Principal Investigator
United States Minnesota Rochester 55905 Mayo Clinic
763-588-0661

David Knopman
Principal Investigator
United States Missouri Saint Louis 63131 Washington University
314-747-2107

Barbara Snider
Principal Investigator
United States Nevada Las Vegas 89113 Las Vegas Medical research
310-993-9118

Bharat Mocherla
Principal Investigator
United States New Jersey Toms River 08755 Advanced Memory Research Institute of NJ, PC
732-341-9500

Sanjiv Sharma
Principal Investigator
United States New York Albany 12208 Albany Medical College
518-262-0800

Earl Zimmerman
Principal Investigator
United States New York New York 10016 New York University Medical Center PRIME
212-263-7744

Martin Sadowski
Principal Investigator
United States New York Rochester 14620 University of Rochester
585-760-6560

Anton Porsteinsson
Principal Investigator
United States North Carolina Charlotte 28270 ANI Neurology, PLLC d/b/a Alzheimer's Memory Center
704-364-4000

Mohammad Bolouri
Principal Investigator
United States North Carolina Raleigh 27607-6010 Raleigh Neurology Associates, P.A.
919-782-3456

Michael Bowman
Principal Investigator
United States Ohio Cleveland 44195 Cleveland Clinic
216-521-2228

Babak Tousi
Principal Investigator
United States Oklahoma Oklahoma City 73112 Lynn Health Science Institute
405-602-3939

Carl Griffin
Principal Investigator
United States Pennsylvania Jenkintown 19046 The Clinical Trial Center, LLC
215-884-1700

Marvin Kalafer
Principal Investigator
United States Pennsylvania Pittsburgh 15213 University of Pittsburgh
412-692-2700

Oscar Lopez
Principal Investigator
United States Pennsylvania Plains 18705 Northeastern Pennsylvania Memory and Alzheimer's Center
570-207-3945

Mario Cornacchione
Principal Investigator
United States Rhode Island East Providence 02915 Rhode Island Mood & Memory Research Institute
401-435-8950

John Stoukides
Principal Investigator
United States Rhode Island Providence 02906 Butler Hospital
401-455-6203

Stephen Salloway
Principal Investigator
United States South Carolina Charleston 29425 Medical University of South Carolina (MUSC)
843-792-3221

David Clark
Principal Investigator
United States Tennessee Cordova 38108 Neurology Clinic, PC
901-866-9252

Lee Stein
Principal Investigator
United States Tennessee Knoxville 37920 University of Tennessee Medical Center. Knoxville
865-305-6740

John Dougherty
Principal Investigator
United States Tennessee Memphis 38119 Clinical Neuroscience Solutions, Inc.
901-843-1045

Lora McGill
Principal Investigator
United States Texas Dallas 75390 UT Southwestern Medical Center at Dallas
214-648-9367

Benjamin Williams
Principal Investigator
United States Texas Houston 77030 Baylor College of Medicine
713-798-4734

Joseph Kass
Principal Investigator
United States Virginia Richmond 23294 National Clinical Research Inc.-Richmond
804-672-2995

John Scott
Principal Investigator
United States Wisconsin Milwaukee 53266 Medical College of Wisconsin, Inc.
414-805-5224

Piero Antuono
Principal Investigator
Australia New South Wales Darlinghurst 2010 St Vincent's Hospital Sydney
Australia New South Wales East Gosford 2250 Central Coast Neurosciences Research, Gosford
Australia New South Wales North Ryde 2113 KARA Institute for Neurological Diseases
Australia New South Wales Waratah 2298 Calvary Mater Newcastle
Australia Queensland Brisbane 4222 Queensland University of Technology
Australia Queensland Chermside 4032 The Prince Charles Hospital
Australia Queensland Herston 4006 Royal Brisbane and Women's Hospital
Australia Queensland Toowoomba 4350 Toowoomba Base Hospital
Australia Victoria Box Hill 3128 Box Hill Hospital
Australia Victoria Heidelberg 3084 Austin Hospital
Australia Western Australia Nedlands 6009 McCusker Alzheimer's Research Foundation
Australia Western Australia West Perth 6005 Neurodegenerative Disorders Research
Austria Graz 8036 LKH - Universitaetsklinikum Graz
Austria Salzburg 5020 Christian-Doppler-Klinik - Universitätsklinikum Salzburg
Austria Vienna 1090 AKH - Medizinische Universität Wien
Canada Alberta Calgary T2N 1N4 Heritage Medical Research Clinic
Canada British Columbia Penticton V2A 5C8 The Medical Arts Health Research Group
Canada British Columbia Vancouver V6T 2B5 UBC Hospital
Canada Ontario Toronto M3B 2S7 Toronto Memory Program (Neurology Research Inc.)
Canada Ontario Toronto M4N 3M5 Toronto Sunnybrook Hospital
Canada Quebec Montreal H3A 2B4 The Montreal Neurological Institute
Canada Quebec Verdun H4H 1R3 McGill Centre for Studies in Aging
Canada Quebec G1J 1Z4 CHU de Quebec - Hôpital de l' Enfant Jésus
Denmark Ballerup 2750 CCBR - Ballerup - DK
+45 4470 4470

Line Markdanner Lindgren
Principal Investigator
Denmark København Ø 2100 Rigshospitalet
+4535456702

Dr. Peter Johannsen
Principal Investigator
Denmark Vejle 7100 CCBR - Vejle - DK
+45 7572 6066

Annette Justesen
Principal Investigator
Denmark Ålborg 9100 CCBR - Ålborg - DK
+45 96334720

Anna Areovimata
Principal Investigator
France Bas Rhin Strasbourg Cedex 67098 CHU Strasbourg - Hôpital Hautepierre
France Bas Rhin Strasbourg 67091 Hopital Louis Pasteur Colmar
00 33 3 89 12 70 97

Pierre Anthony
Principal Investigator
France Gironde Bordeaux 33076 Groupe Hospitalier Pellegrin - Hôpital Pellegrin
05 57 82 01 16

Sophie Auriacombe
Principal Investigator
France Marne Reims 51092 CHU Reims - Hôpital Maison Blanche
France Rhone Bron Cedex 69677 Hopital Neurologique Pierre Wertheimer
+33 4-72-35-71-32

Helene Mollion
Principal Investigator
France Paris 75013 Groupe hospitalier Broca - La Rochefoucauld - La Collégiale
France Paris 75013 Groupe Hospitalier Pitie-Salpetriere
33 1 42 16 7501

Bruno Dubois
Principal Investigator
Germany Baden Wuerttemberg Boeblingen 71034 Praxis Dr. Scholz
Germany Baden Wuerttemberg Ostfildern 73760 Aerztliche Gemeinschaftspraxis
Germany Baden Wuerttemberg Stuttgart 70182 Neuro MVZ Stuttgart
Germany Bayern Frankfurt 97080 Klinikum der Johann Wolfgang Goethe-Universitaet
Germany Bayern Neuburg 86633 Praxis Dr. med. Bergmann
Germany Hessen Kassel 34121 Neurologische Gemeinschaftspraxis Kassel
Germany Niedersachsen Hannover 30159 Klinische Forschung Hannover-Mitte GmbH
Germany Nordrhein Westfalen Aachen 52074 Universitaetsklinikum Aachen AOeR
Germany Nordrhein Westfalen Bonn 53127 Universitaetsklinikum Bonn AoeR
Germany Nordrhein Westfalen Cologne 53105 Universitaetsklinikum Koeln
Germany Berlin 14050 Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
Italy Ancona Torrette di Ancona 60126 Azienda Ospedaliero Universitaria Ospedali Riuniti
Italy Palermo Cefalù 90015 Fondazione Istituto G.Giglio di Cefalù
Italy Brescia 25100 Azienda Ospedaliera Spedali Civili di Brescia
Italy Genova 16132 Azienda Ospedaliero Universitaria San Martino
Italy Milano 20132 Ospedale San Raffaele
Italy Milano 20144 Casa di Cura del Policlinico
Italy Napoli 80131 Azienda Ospedaliera Universitaria "Federico II"
Italy Napoli 80138 Seconda Università degli Studi di Napoli
Italy Pisa 56126 Azienda Ospedaliero Universitaria Pisana
Italy Roma 00168 Policlinico Universitario Agostino Gemelli
Italy Salerno 84131 Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona
Italy Siena 53100 A.O.U. Senese Policlinico Santa Maria alle Scotte
Japan Chiba-Ken Chiba-Shi 263-0043 Research Site
Japan Chiba-Ken Inzai-shi Research Site
Japan Fukushima-Ken Aizuwakamatsu-shi 965-8585 Research Site
Japan Hokkaido Asahikawa-shi 070-8644 Research Site
Japan Hokkaido Sapporo-shi 064-8570 Research Site
Japan Kanagawa-Ken Atsugi-shi 243-8551 Research Site
Japan Kanagawa-Ken Kamakura-shi 247-8533 Research Site
Japan Kanagawa-Ken Kawasaki-Shi 211-8533 Research Site
Japan Kanagawa-Ken Yokohama-shi 225-0013 Research Site
Japan Kanagawa-Ken Yokohama-shi 225-0025 Research Site
Japan Niigata-Ken Nagaoka-shi 940-2081 Research Site
Japan Saitama-Ken Iruma-gun 350-0495 Research Site
Japan Saitama-Ken Kasukabe-shi 344-0036 Research Site
Japan Tokyo-To Bunkyo-ku 113-0034 Research Site
Japan Tokyo-To Shinjuku-ku (I) 162-8655 Research Site
Japan Tokyo-To Shinjuku-ku 162-8655 Research Site
Japan Tokyo Ota-ku 143-8541 Research Site
Japan Yamagata-Ken Yamagata-shi 990-0834 Research Site
Japan Itabashi-ku 173-0015 Research Site
Japan Kiyose-shi Research Site
Japan Kodaira-shi 187-8551 Research Site
Korea, Republic of Gyeonggi-do Incheon 22332 Inha University Hospital
Korea, Republic of Gyeonggi-do Seongnam-si 13620 Seoul National University Bundang Hospital
Korea, Republic of Incheon 21565 Gachon University Gil Medical Center
Korea, Republic of Seoul 05505 Asan Medical Center
Korea, Republic of Seoul 06351 Samsung Medical Center
Korea, Republic of Seoul 143-729 Konkuk University Medical Center
Portugal Amadora 2720-276 Hospital Professor Doutor Fernando Fonseca, E.P.E.
Portugal Braga 4710-243 Hospital de Braga
Portugal Coimbra 3040-278 Centro Hospitalar e Universitário de Coimbra E.P.E
Portugal Loures 2674-514 Hospital Beatriz Ângelo
Portugal Torres Vedras 2560-280 Campus Neurologico Senior
Spain Guipuzcoa San Sebastian 20014 Policlinica Guipuzcoa
+34 637 45 01 82

Nadege Van Blercon
Principal Investigator
Spain Vizcaya Barakaldo 48903 Hospital de Cruces
Spain Barcelona 08028 Fundacio ACE
Spain Barcelona 08036 Hospital Clinic i Provincial de Barcelona
Spain Barcelona 08041 Hospital de la Santa Creu i Sant Pau
Spain Madrid 28006 Clinica Ruber
Spain Valencia 46017 Hospital Universitario Dr. Peset
Spain Valencia 46026 Hospital Universitari i Politecnic La Fe
Taiwan Changhua 500 Changhua Christian Hospital
Taiwan Kaohsiung 807 Kaohsiung Medical University Chung-Ho Memorial Hospital
Taiwan Kaohsiung 83301 Kaohsiung Chang Gung Memorial Hospital
Taiwan Tainan 704 National Cheng Kung University Hospital
Taiwan Taipei 100 National Taiwan University Hospital
Taiwan Taoyuan County 333 Chang Gung Memorial Hospital, Linkou
United Kingdom Avon Bristol BS16 1LE Southmead Hospital
United Kingdom Greater London London W1G 9JF Re:Cognition Health Ltd
United Kingdom Greater London London W6 8RF Charing Cross Hospital
United Kingdom Greater London London WC1N 3BG The National Hospital for Neurology and Neurosurgery Centre
United Kingdom Greater Manchester Salford M6 8HD Salford Royal
United Kingdom Lothian Region Edinburgh EH8 9YL The University of Edinburgh
07736069590

Ritchie Craig
Principal Investigator
United Kingdom Middlesex Isleworth TW7 6AF West Middlesex Hospital
United Kingdom Somerset Bath BA1 3NG The RICE Centre
United Kingdom Strathclyde Glasgow G20 0XA Glasgow Memory Clinic Ltd
United Kingdom Strathclyde Glasgow G21 3UW Stobhill ACH Hospital
United Kingdom Tayside Region Dundee DD2 1GZ Ninewells Hospital
United Kingdom Tyne & Wear Newcastle upon Tyne NE4 5PL Newcastle University
441912481270

Andrew Byrne
Principal Investigator

Contact

Aducanumab Global Clinical Trial Center

E-mail:

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