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221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease (ENGAGE)
This study is currently recruiting participants.
Verified June 2017 by Biogen
Sponsor:
Biogen
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT02477800
First received: June 18, 2015
Last updated: June 2, 2017
Last verified: June 2017
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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].
| Condition | Intervention | Phase |
|---|---|---|
| Alzheimer's Disease | Drug: Aducanumab (BIIB037) Drug: Placebo | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Care Provider, Investigator, Outcomes Assessor Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
Further study details as provided by Biogen:
Primary Outcome Measures:
- Change from baseline in CDR-SB score [ Time Frame: Week 78 ]
Secondary Outcome Measures:
- Change from baseline in MMSE score [ Time Frame: Week 78 ]
- Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (13 items) (ADAS-Cog 13) [ Time Frame: Week 78 ]
- Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) (ADCS-ADL-MCI) score [ Time Frame: Week 78 ]
| Estimated Enrollment: | 1350 |
| Actual Study Start Date: | August 31, 2015 |
| Estimated Study Completion Date: | March 5, 2022 |
| Estimated Primary Completion Date: | November 18, 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Low Dose
Monthly intravenous (IV) infusion
|
Drug: Aducanumab (BIIB037)
Low dose
Drug: Placebo
Placebo
|
|
Experimental: High Dose
Monthly intravenous (IV) infusion
|
Drug: Aducanumab (BIIB037)
High dose
Drug: Placebo
Placebo
|
Eligibility| Ages Eligible for Study: | 50 Years to 85 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02477800
Hide Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02477800
Contacts
| Contact: Aducanumab Global Clinical Trial Center | clinicaltrials@biogen.com | ||
| Contact: Aducanumab US Call Center | 877-231-7271 | clinicaltrials@biogen.com |
Hide Study Locations
Locations
| United States, Arizona | |
| St. Joseph's Hospital and Medical Center | Recruiting |
| Phoenix, Arizona, United States, 85013 | |
| Contact 602-406-6262 | |
| Principal Investigator: Jiong Shi | |
| Center for Neurosciences | Recruiting |
| Tucson, Arizona, United States, 85718 | |
| Contact 520-320-2147 | |
| Principal Investigator: Michael Badruddoja | |
| United States, California | |
| Neurology Center of North Orange County | Recruiting |
| Fullerton, California, United States, 92835 | |
| Contact 714-879-7200 | |
| Principal Investigator: Anthony Ciabarra | |
| Senior Clinical Trials, Inc. | Recruiting |
| Laguna Hills, California, United States, 92653 | |
| Contact 949-588-0909 | |
| Principal Investigator: Robert Feldman | |
| Torrance Clinical Research Institute, Inc. | Active, not recruiting |
| Lomita, California, United States, 90717 | |
| University of California - Los Angeles | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact 310-794-6191 | |
| Principal Investigator: Sarah Kremen | |
| UCSF - Memory and Aging Center | Recruiting |
| San Francisco, California, United States, 94158 | |
| Contact 415-476-8333 | |
| Principal Investigator: Adam Boxer | |
| California Neuroscience Research Medical Group Inc. | Recruiting |
| Sherman Oaks, California, United States, 91403 | |
| Contact 818-990-2671 | |
| Principal Investigator: Thomas Shiovitz | |
| Southern California Research LLC | Recruiting |
| Simi Valley, California, United States, 93065 | |
| Contact 818-631-7489 | |
| Principal Investigator: Brock Summers | |
| United States, Connecticut | |
| Institute for Neurodegenerative Disorders | Recruiting |
| New Haven, Connecticut, United States, 06510 | |
| Contact 203-401-4300 | |
| Principal Investigator: David Russell | |
| United States, District of Columbia | |
| Georgetown University Hospital | Recruiting |
| Washington, D.C., District of Columbia, United States, 20057 | |
| Contact 202-687-7337 | |
| Principal Investigator: Raymond Turner | |
| United States, Florida | |
| Brain Matters Research, Inc. | Recruiting |
| Delray Beach, Florida, United States, 33445 | |
| Contact 561-374-8461 | |
| Principal Investigator: Mark Brody | |
| Neuropsychiatric Research Center of Southwest Florida | Recruiting |
| Fort Myers, Florida, United States, 33912 | |
| Contact 239-939-7777 | |
| Principal Investigator: Frederick Schaerf | |
| Jacksonville Center for Clinical Research | Recruiting |
| Jacksonville, Florida, United States, 32216 | |
| Contact 904-730-0101 | |
| Principal Investigator: Erin Doty | |
| University of Miami | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact 305-243-0184 | |
| Principal Investigator: Barry Baumel | |
| Miami Jewish Health Systems | Recruiting |
| Miami, Florida, United States, 33137 | |
| Contact 305-751-8626 | |
| Principal Investigator: Marc Agronin | |
| New Horizon Research Center, Inc | Active, not recruiting |
| Miami, Florida, United States, 33175 | |
| Compass Research Main | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact 407-426-9299 | |
| Principal Investigator: Craig Curtis | |
| Palm Beach Neurological Center | Recruiting |
| Palm Beach Gardens, Florida, United States, 33410 | |
| Contact 561-282-5541 | |
| Principal Investigator: Michael Tuchman | |
| Stedman Clinical Trials, LLC | Recruiting |
| Tampa, Florida, United States, 33613 | |
| Contact 813-971-8311 | |
| Principal Investigator: Mary Stedman | |
| USF Health Byrd Institute | Recruiting |
| Tampa, Florida, United States, 33616 | |
| Contact 813-974-4355 | |
| Principal Investigator: Amanda Smith | |
| Meridien Research | Recruiting |
| Tampa, Florida, United States, 33634 | |
| Contact 813-877-8839 | |
| Principal Investigator: Cynthia Huffman | |
| Compass Research Main | Recruiting |
| The Villages, Florida, United States, 32162 | |
| Contact 352-261-0901 | |
| Principal Investigator: David Subich | |
| Premiere Research Institute | Recruiting |
| West Palm Beach, Florida, United States, 33407 | |
| Contact 561-845-0500 | |
| Principal Investigator: Walter Martinez | |
| Cleveland Clinic Florida - Weston | Recruiting |
| Weston, Florida, United States, 33331 | |
| Contact 954-659-5670 | |
| Principal Investigator: Po-Heng Tsai | |
| United States, Georgia | |
| MS Center of Atlanta | Active, not recruiting |
| Atlanta, Georgia, United States, 30327 | |
| United States, Illinois | |
| Alexian Brothers Neurosciences Institute | Recruiting |
| Elk Grove Village, Illinois, United States, 60007 | |
| Contact 847-593-8553 | |
| Principal Investigator: Concetta Forchetti | |
| Advocate Lutheran General Hospital | Recruiting |
| Park Ridge, Illinois, United States, 60068 | |
| Contact 847-720-6464 | |
| Principal Investigator: Darren Gitelman | |
| United States, Indiana | |
| Fort Wayne Neurological Center | Recruiting |
| Fort Wayne, Indiana, United States, 46804 | |
| Contact 260-436-3991 | |
| Principal Investigator: James Stevens | |
| Indiana University School of Medicine | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact 317-963-7411 | |
| Principal Investigator: Martin Farlow | |
| United States, Kansas | |
| University of Kansas Medical Center Research Institute, Inc. | Recruiting |
| Kansas City, Kansas, United States, 66160 | |
| Contact 913-588-0555 | |
| Principal Investigator: Jeffrey Burns | |
| Via Christi Research, a division of Via Christi Hospitals Wichita, Inc. | Recruiting |
| Wichita, Kansas, United States, 67214 | |
| Contact 316-291-4774 | |
| Principal Investigator: Paul Murphy | |
| United States, Kentucky | |
| Baptist Health Lexington | Recruiting |
| Lexington, Kentucky, United States, 40503 | |
| Contact 859-260-4330 | |
| Principal Investigator: Gregory Cooper | |
| United States, Massachusetts | |
| Brigham & Women's Hosp End/Dbt | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact 617-732-8085 | |
| Principal Investigator: Scott McGinnis | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact 617-667-5553 | |
| Principal Investigator: Henry Querfurth | |
| ActivMed Practices & Research | Recruiting |
| Methuen, Massachusetts, United States, 01844 | |
| Contact 978-655-7155 | |
| Principal Investigator: Michael McCartney | |
| Donald S. Marks, M.D., P.C. | Recruiting |
| Plymouth, Massachusetts, United States, 02360 | |
| Contact 508-746-5060 | |
| Principal Investigator: Donald Marks | |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact 763-588-0661 | |
| Principal Investigator: David Knopman | |
| United States, Missouri | |
| Washington University | Not yet recruiting |
| Saint Louis, Missouri, United States, 63131 | |
| Contact 314-747-2107 | |
| Principal Investigator: Barbara Snider | |
| United States, Nevada | |
| Las Vegas Medical research | Recruiting |
| Las Vegas, Nevada, United States, 89113 | |
| Contact 310-993-9118 | |
| Principal Investigator: Bharat Mocherla | |
| United States, New Jersey | |
| Advanced Memory Research Institute of NJ, PC | Recruiting |
| Toms River, New Jersey, United States, 08755 | |
| Contact 732-341-9500 | |
| Principal Investigator: Sanjiv Sharma | |
| United States, New York | |
| Albany Medical College | Recruiting |
| Albany, New York, United States, 12208 | |
| Contact 518-262-0800 | |
| Principal Investigator: Earl Zimmerman | |
| New York University Medical Center PRIME | Recruiting |
| New York, New York, United States, 10016 | |
| Contact 212-263-7744 | |
| Principal Investigator: Martin Sadowski | |
| University of Rochester | Recruiting |
| Rochester, New York, United States, 14620 | |
| Contact 585-760-6560 | |
| Principal Investigator: Anton Porsteinsson | |
| United States, North Carolina | |
| ANI Neurology, PLLC d/b/a Alzheimer's Memory Center | Recruiting |
| Charlotte, North Carolina, United States, 28270 | |
| Contact 704-364-4000 | |
| Principal Investigator: Mohammad Bolouri | |
| Raleigh Neurology Associates, P.A. | Recruiting |
| Raleigh, North Carolina, United States, 27607-6010 | |
| Contact 919-782-3456 | |
| Principal Investigator: Michael Bowman | |
| United States, Ohio | |
| Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact 216-521-2228 | |
| Principal Investigator: Babak Tousi | |
| United States, Oklahoma | |
| Lynn Health Science Institute | Recruiting |
| Oklahoma City, Oklahoma, United States, 73112 | |
| Contact 405-602-3939 | |
| Principal Investigator: Carl Griffin | |
| United States, Pennsylvania | |
| The Clinical Trial Center, LLC | Recruiting |
| Jenkintown, Pennsylvania, United States, 19046 | |
| Contact 215-884-1700 | |
| Principal Investigator: Marvin Kalafer | |
| University of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact 412-692-2700 | |
| Principal Investigator: Oscar Lopez | |
| Northeastern Pennsylvania Memory and Alzheimer's Center | Recruiting |
| Plains, Pennsylvania, United States, 18705 | |
| Contact 570-207-3945 | |
| Principal Investigator: Mario Cornacchione | |
| United States, Rhode Island | |
| Rhode Island Mood & Memory Research Institute | Recruiting |
| East Providence, Rhode Island, United States, 02915 | |
| Contact 401-435-8950 | |
| Principal Investigator: John Stoukides | |
| Butler Hospital | Recruiting |
| Providence, Rhode Island, United States, 02906 | |
| Contact 401-455-6203 | |
| Principal Investigator: Stephen Salloway | |
| United States, South Carolina | |
| Medical University of South Carolina (MUSC) | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact 843-792-3221 | |
| Principal Investigator: David Clark | |
| United States, Tennessee | |
| Neurology Clinic, PC | Recruiting |
| Cordova, Tennessee, United States, 38108 | |
| Contact 901-866-9252 | |
| Principal Investigator: Lee Stein | |
| Quillen College Of Medicine, East Tn State University | Active, not recruiting |
| Johnson City, Tennessee, United States, 37614 | |
| University of Tennessee Medical Center. Knoxville | Recruiting |
| Knoxville, Tennessee, United States, 37920 | |
| Contact 865-305-6740 | |
| Principal Investigator: John Dougherty | |
| Clinical Neuroscience Solutions, Inc. | Recruiting |
| Memphis, Tennessee, United States, 38119 | |
| Contact 901-843-1045 | |
| Principal Investigator: Lora McGill | |
| United States, Texas | |
| UT Southwestern Medical Center at Dallas | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact 214-648-9367 | |
| Principal Investigator: Benjamin Williams | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact 713-798-4734 | |
| Principal Investigator: Joseph Kass | |
| United States, Virginia | |
| National Clinical Research Inc.-Richmond | Recruiting |
| Richmond, Virginia, United States, 23294 | |
| Contact 804-672-2995 | |
| Principal Investigator: John Scott | |
| United States, Wisconsin | |
| Medical College of Wisconsin, Inc. | Recruiting |
| Milwaukee, Wisconsin, United States, 53266 | |
| Contact 414-805-5224 | |
| Principal Investigator: Piero Antuono | |
| Australia, New South Wales | |
| St Vincent's Hospital Sydney | Recruiting |
| Darlinghurst, New South Wales, Australia, 2010 | |
| Central Coast Neurosciences Research, Gosford | Recruiting |
| East Gosford, New South Wales, Australia, 2250 | |
| KARA Institute for Neurological Diseases | Recruiting |
| North Ryde, New South Wales, Australia, 2113 | |
| Calvary Mater Newcastle | Recruiting |
| Waratah, New South Wales, Australia, 2298 | |
| Australia, Queensland | |
| Queensland University of Technology | Recruiting |
| Brisbane, Queensland, Australia, 4222 | |
| The Prince Charles Hospital | Recruiting |
| Chermside, Queensland, Australia, 4032 | |
| Royal Brisbane and Women's Hospital | Recruiting |
| Herston, Queensland, Australia, 4006 | |
| Toowoomba Base Hospital | Recruiting |
| Toowoomba, Queensland, Australia, 4350 | |
| Australia, Victoria | |
| Box Hill Hospital | Recruiting |
| Box Hill, Victoria, Australia, 3128 | |
| Austin Hospital | Recruiting |
| Heidelberg, Victoria, Australia, 3084 | |
| Royal Melbourne Hospital | Active, not recruiting |
| Parkville, Victoria, Australia, 3050 | |
| Epworth Healthcare | Active, not recruiting |
| Richmond, Victoria, Australia, 3121 | |
| Australia, Western Australia | |
| McCusker Alzheimer's Research Foundation | Recruiting |
| Nedlands, Western Australia, Australia, 6009 | |
| Neurodegenerative Disorders Research | Recruiting |
| West Perth, Western Australia, Australia, 6005 | |
| Austria | |
| LKH - Universitaetsklinikum Graz | Recruiting |
| Graz, Austria, 8036 | |
| Christian-Doppler-Klinik - Universitätsklinikum Salzburg | Recruiting |
| Salzburg, Austria, 5020 | |
| AKH - Medizinische Universität Wien | Active, not recruiting |
| Vienna, Austria, 1090 | |
| AKH - Medizinische Universität Wien | Recruiting |
| Vienna, Austria, 1090 | |
| Canada, Alberta | |
| Heritage Medical Research Clinic | Recruiting |
| Calgary, Alberta, Canada, T2N 1N4 | |
| Canada, British Columbia | |
| The Medical Arts Health Research Group | Recruiting |
| Penticton, British Columbia, Canada, V2A 5C8 | |
| UBC Hospital | Recruiting |
| Vancouver, British Columbia, Canada, V6T 2B5 | |
| Canada, Ontario | |
| Toronto Memory Program (Neurology Research Inc.) | Recruiting |
| Toronto, Ontario, Canada, M3B 2S7 | |
| Toronto Sunnybrook Hospital | Recruiting |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Canada, Quebec | |
| The Montreal Neurological Institute | Recruiting |
| Montreal, Quebec, Canada, H3A 2B4 | |
| McGill Centre for Studies in Aging | Recruiting |
| Verdun, Quebec, Canada, H4H 1R3 | |
| Canada | |
| CHU de Quebec - Hôpital de l' Enfant Jésus | Recruiting |
| Quebec, Canada, G1J 1Z4 | |
| Denmark | |
| CCBR - Ballerup - DK | Recruiting |
| Ballerup, Denmark, 2750 | |
| Contact +45 4470 4470 | |
| Principal Investigator: Line Markdanner Lindgren | |
| Rigshospitalet | Recruiting |
| København Ø, Denmark, 2100 | |
| Contact +4535456702 | |
| Principal Investigator: Dr. Peter Johannsen | |
| CCBR - Vejle - DK | Recruiting |
| Vejle, Denmark, 7100 | |
| Contact +45 7572 6066 | |
| Principal Investigator: Annette Justesen | |
| CCBR - Ålborg - DK | Recruiting |
| Ålborg, Denmark, 9100 | |
| Contact +45 96334720 | |
| Principal Investigator: Anna Areovimata | |
| France | |
| CHU Strasbourg - Hôpital Hautepierre | Recruiting |
| Strasbourg Cedex, Bas Rhin, France, 67098 | |
| Hopital Louis Pasteur Colmar | Recruiting |
| Strasbourg, Bas Rhin, France, 67091 | |
| Contact 00 33 3 89 12 70 97 | |
| Principal Investigator: Pierre Anthony | |
| CHU Dijon - Hopital General# | Active, not recruiting |
| Dijon, Côte-d'Or, France, 21079 | |
| Groupe Hospitalier Pellegrin - Hôpital Pellegrin | Recruiting |
| Bordeaux, Gironde, France, 33076 | |
| Contact 05 57 82 01 16 | |
| Principal Investigator: Sophie Auriacombe | |
| CHU Reims - Hôpital Maison Blanche | Recruiting |
| Reims, Marne, France, 51092 | |
| Hopital Neurologique Pierre Wertheimer | Recruiting |
| Bron Cedex, Rhone, France, 69677 | |
| Contact +33 4-72-35-71-32 | |
| Principal Investigator: Helene Mollion | |
| Groupe hospitalier Broca - La Rochefoucauld - La Collégiale | Recruiting |
| Paris, France, 75013 | |
| Groupe Hospitalier Pitie-Salpetriere | Recruiting |
| Paris, France, 75013 | |
| Contact 33 1 42 16 7501 | |
| Principal Investigator: Bruno Dubois | |
| Germany | |
| Praxis Dr. Scholz | Recruiting |
| Boeblingen, Baden Wuerttemberg, Germany, 71034 | |
| Aerztliche Gemeinschaftspraxis | Recruiting |
| Ostfildern, Baden Wuerttemberg, Germany, 73760 | |
| Neuro MVZ Stuttgart | Recruiting |
| Stuttgart, Baden Wuerttemberg, Germany, 70182 | |
| Klinikum der Johann Wolfgang Goethe-Universitaet | Recruiting |
| Frankfurt, Bayern, Germany, 97080 | |
| Praxis Dr. med. Bergmann | Recruiting |
| Neuburg, Bayern, Germany, 86633 | |
| Neurologische Gemeinschaftspraxis Kassel | Recruiting |
| Kassel, Hessen, Germany, 34121 | |
| Klinische Forschung Hannover-Mitte GmbH | Recruiting |
| Hannover, Niedersachsen, Germany, 30159 | |
| Universitaetsklinikum Aachen AOeR | Recruiting |
| Aachen, Nordrhein Westfalen, Germany, 52074 | |
| Universitaetsklinikum Bonn AoeR | Recruiting |
| Bonn, Nordrhein Westfalen, Germany, 53127 | |
| Universitaetsklinikum Koeln | Recruiting |
| Cologne, Nordrhein Westfalen, Germany, 53105 | |
| Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin | Recruiting |
| Berlin, Germany, 14050 | |
| Italy | |
| Azienda Ospedaliero Universitaria Ospedali Riuniti | Recruiting |
| Torrette di Ancona, Ancona, Italy, 60126 | |
| Fondazione Istituto G.Giglio di Cefalù | Not yet recruiting |
| Cefalù, Palermo, Italy, 90015 | |
| Azienda Ospedaliera Ospedali Riuniti di Bergamo | Not yet recruiting |
| Bergamo, Italy, 24100 | |
| Azienda Ospedaliera Spedali Civili di Brescia | Recruiting |
| Brescia, Italy, 25100 | |
| Azienda Ospedaliero Universitaria San Martino | Recruiting |
| Genova, Italy, 16132 | |
| Ospedale San Raffaele | Recruiting |
| Milano, Italy, 20132 | |
| Casa di Cura del Policlinico | Recruiting |
| Milano, Italy, 20144 | |
| Azienda Ospedaliera Universitaria "Federico II" | Recruiting |
| Napoli, Italy, 80131 | |
| Seconda Università degli Studi di Napoli | Recruiting |
| Napoli, Italy, 80138 | |
| Azienda Ospedaliero Universitaria Pisana | Recruiting |
| Pisa, Italy, 56126 | |
| Policlinico Universitario Agostino Gemelli | Recruiting |
| Roma, Italy, 00168 | |
| Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona | Recruiting |
| Salerno, Italy, 84131 | |
| A.O.U. Senese Policlinico Santa Maria alle Scotte | Recruiting |
| Siena, Italy, 53100 | |
| Japan | |
| Research Site | Recruiting |
| Chiba-Shi, Chiba-Ken, Japan, 263-0043 | |
| Research Site | Recruiting |
| Inzai-shi, Chiba-Ken, Japan | |
| Research Site | Recruiting |
| Aizuwakamatsu-shi, Fukushima-Ken, Japan, 965-8585 | |
| Research Site | Recruiting |
| Asahikawa-shi, Hokkaido, Japan, 070-8644 | |
| Research Site | Not yet recruiting |
| Sapporo-shi, Hokkaido, Japan, 006-8555 | |
| Research Site | Recruiting |
| Sapporo-shi, Hokkaido, Japan, 064-8570 | |
| Research Site | Recruiting |
| Atsugi-shi, Kanagawa-Ken, Japan, 243-8551 | |
| Research Site | Recruiting |
| Kamakura-shi, Kanagawa-Ken, Japan, 247-8533 | |
| Research Site | Not yet recruiting |
| Kawasaki-Shi, Kanagawa-Ken, Japan, 211-8533 | |
| Research Site | Not yet recruiting |
| Yokohama-shi, Kanagawa-Ken, Japan, 225-0025 | |
| Research Site | Not yet recruiting |
| Yokohama-shi, Kanagawa-Ken, Japan, 236-0004 | |
| Research Site | Recruiting |
| Nagaoka-shi, Niigata-Ken, Japan, 940-2081 | |
| Research Site | Recruiting |
| Kasukabe-shi, Saitama-Ken, Japan, 344-0036 | |
| Research Site | Recruiting |
| Bunkyo-ku, Tokyo-To, Japan, 113-0034 | |
| Research Site | Not yet recruiting |
| Bunkyo-ku, Tokyo-To, Japan, 113-8603 | |
| Research Site | Recruiting |
| Shinjuku-ku (I), Tokyo-To, Japan, 162-8655 | |
| Research Site | Recruiting |
| Shinjuku-ku, Tokyo-To, Japan, 162-8655 | |
| Research Site | Recruiting |
| Ota-ku, Tokyo, Japan, 143-8541 | |
| Research Site | Recruiting |
| Yamagata-shi, Yamagata-Ken, Japan, 990-0834 | |
| Research Site | Recruiting |
| Itabashi-ku, Japan, 173-0015 | |
| Research Site | Recruiting |
| Itabashi-ku, Japan, 173-8610 | |
| Research Site | Recruiting |
| Kiyose-shi, Japan | |
| Research Site | Recruiting |
| Kodaira-shi, Japan, 187-8551 | |
| Research Site | Not yet recruiting |
| Tsukuba-shi, Japan | |
| Korea, Republic of | |
| Inha University Hospital | Recruiting |
| Incheon, Gyeonggi-do, Korea, Republic of, 22332 | |
| Seoul National University Bundang Hospital | Recruiting |
| Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620 | |
| Gachon University Gil Medical Center | Recruiting |
| Incheon, Korea, Republic of, 21565 | |
| Asan Medical Center | Recruiting |
| Seoul, Korea, Republic of, 05505 | |
| Samsung Medical Center | Recruiting |
| Seoul, Korea, Republic of, 06351 | |
| Konkuk University Medical Center | Recruiting |
| Seoul, Korea, Republic of, 143-729 | |
| Portugal | |
| Hospital Professor Doutor Fernando Fonseca, E.P.E. | Recruiting |
| Amadora, Portugal, 2720-276 | |
| Hospital de Braga | Recruiting |
| Braga, Portugal, 4710-243 | |
| Centro Hospitalar e Universitário de Coimbra E.P.E | Recruiting |
| Coimbra, Portugal, 3040-278 | |
| Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria | Recruiting |
| Lisboa, Portugal, 1649-035 | |
| Hospital Beatriz Ângelo | Recruiting |
| Loures, Portugal, 2674-514 | |
| Campus Neurologico Senior | Recruiting |
| Torres Vedras, Portugal, 2560-280 | |
| Spain | |
| Policlinica Guipuzcoa | Recruiting |
| San Sebastian, Guipuzcoa, Spain, 20014 | |
| Contact +34 637 45 01 82 | |
| Principal Investigator: Nadege Van Blercon | |
| Hospital de Cruces | Recruiting |
| Barakaldo, Vizcaya, Spain, 48903 | |
| Fundacio ACE | Recruiting |
| Barcelona, Spain, 08028 | |
| Hospital Clinic i Provincial de Barcelona | Recruiting |
| Barcelona, Spain, 08036 | |
| Hospital de la Santa Creu i Sant Pau | Recruiting |
| Barcelona, Spain, 08041 | |
| Clinica Ruber | Recruiting |
| Madrid, Spain, 28006 | |
| Hospital Universitario Dr. Peset | Recruiting |
| Valencia, Spain, 46017 | |
| Hospital Universitari i Politecnic La Fe | Recruiting |
| Valencia, Spain, 46026 | |
| Taiwan | |
| Changhua Christian Hospital | Recruiting |
| Changhua, Taiwan, 500 | |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Recruiting |
| Kaohsiung, Taiwan, 807 | |
| Kaohsiung Chang Gung Memorial Hospital | Recruiting |
| Kaohsiung, Taiwan, 83301 | |
| National Cheng Kung University Hospital | Recruiting |
| Tainan, Taiwan, 704 | |
| National Taiwan University Hospital | Recruiting |
| Taipei, Taiwan, 100 | |
| Chang Gung Memorial Hospital, Linkou | Recruiting |
| Taoyuan County, Taiwan, 333 | |
| United Kingdom | |
| Southmead Hospital | Recruiting |
| Bristol, Avon, United Kingdom, BS16 1LE | |
| Re:Cognition Health Ltd | Recruiting |
| London, Greater London, United Kingdom, W1G 9JF | |
| Charing Cross Hospital | Recruiting |
| London, Greater London, United Kingdom, W6 8RF | |
| The National Hospital for Neurology and Neurosurgery Centre | Recruiting |
| London, Greater London, United Kingdom, WC1N 3BG | |
| Salford Royal | Recruiting |
| Salford, Greater Manchester, United Kingdom, M6 8HD | |
| The University of Edinburgh | Recruiting |
| Edinburgh, Lothian Region, United Kingdom, EH8 9YL | |
| Contact 07736069590 | |
| Principal Investigator: Ritchie Craig | |
| West Middlesex Hospital | Recruiting |
| Isleworth, Middlesex, United Kingdom, TW7 6AF | |
| The RICE Centre | Recruiting |
| Bath, Somerset, United Kingdom, BA1 3NG | |
| Glasgow Memory Clinic Ltd | Recruiting |
| Glasgow, Strathclyde, United Kingdom, G20 0XA | |
| Stobhill ACH Hospital | Recruiting |
| Glasgow, Strathclyde, United Kingdom, G21 3UW | |
| Ninewells Hospital | Recruiting |
| Dundee, Tayside Region, United Kingdom, DD2 1GZ | |
| Newcastle University | Recruiting |
| Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE4 5PL | |
| Contact 441912481270 | |
| Principal Investigator: Andrew Byrne | |
| Kingshill Research Centre | Active, not recruiting |
| Chippenham, Wiltshire, United Kingdom, SN15 1GG | |
Sponsors and Collaborators
Biogen
Investigators
| Study Director: | Medical Director | Biogen |
More Information
Additional Information:
| Responsible Party: | Biogen |
| ClinicalTrials.gov Identifier: | NCT02477800 History of Changes |
| Other Study ID Numbers: |
221AD301 2015-000966-72 ( EudraCT Number ) |
| Study First Received: | June 18, 2015 |
| Last Updated: | June 2, 2017 |
Keywords provided by Biogen:
|
BIIB037 Aducanumab |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on July 14, 2017