221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease



Status:Active, not recruiting
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - 85
Updated:8/8/2018
Start Date:August 31, 2015
End Date:April 30, 2022

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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

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].


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
We found this trial at
60
sites
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Piero Antuono
Phone: 414-805-5224
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Henry Querfurth
Phone: 617-667-5553
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Babak Tousi
Phone: 216-521-2228
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Joseph Kass
Phone: 713-798-4734
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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4085 University Blvd S # 1
Jacksonville, Florida 32216
Principal Investigator: Erin Doty
Phone: 904-730-0101
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1924 Alcoa Highway
Knoxville, Tennessee 37920
Principal Investigator: John Dougherty
Phone: 865-305-6740
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Los Angeles, California 90095
310-825-4321
Principal Investigator: Sarah Kremen
Phone: 310-794-6191
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Barry Baumel
Phone: 305-243-0184
University of Miami A private research university with more than 15,000 students from around the...
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Principal Investigator: Oscar Lopez
Phone: 412-692-2700
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Anton Porsteinsson
Phone: 585-760-6560
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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3212 Cove Bend Drive
Tampa, Florida 33613
Principal Investigator: Mary Stedman
Phone: 813-971-8311
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2450 E. River Road
Tucson, Arizona 85718
520-320-2147
Principal Investigator: Michael Badruddoja
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Principal Investigator: Earl Zimmerman
Phone: 518-262-0800
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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Boston, Massachusetts 02115
Principal Investigator: Scott McGinnis
Phone: 617-732-8085
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Charleston, South Carolina 29425
Principal Investigator: David Clark
Phone: 843-792-3221
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Charlotte, North Carolina 28270
Principal Investigator: Mohammad Bolouri
Phone: 704-364-4000
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Cordova, Tennessee 38018
Principal Investigator: Lee Stein
Phone: 901-866-9252
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Dallas, Texas 75390
Principal Investigator: Benjamin Williams
Phone: 214-648-9367
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Darlinghurst, New South Wales 2010
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Delray Beach, Florida 33445
Principal Investigator: Mark Brody
Phone: 561-374-8461
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East Providence, Rhode Island 02914
Principal Investigator: John Stoukides
Phone: 401-435-8950
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Elk Grove Village, Illinois 60007
Principal Investigator: Concetta Forchetti
Phone: 847-593-8553
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Fort Myers, Florida 33912
Principal Investigator: Frederick Schaerf
Phone: 239-939-7777
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Fort Wayne, Indiana 46805
Principal Investigator: James Stevens
Phone: 260-436-3991
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Fullerton, California 92835
Principal Investigator: Anthony Ciabarra
Phone: 714-879-7200
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340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Principal Investigator: Martin Farlow
Phone: 317-963-7411
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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Jenkintown, Pennsylvania 19046
Principal Investigator: Marvin Kalafer
Phone: 215-884-1700
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Kansas City, Kansas
Principal Investigator: Jeffrey Burns
Phone: 913-588-0555
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Laguna Hills, California 92653
Principal Investigator: Robert Feldman
Phone: 949-588-0909
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Las Vegas, Nevada 89113
Principal Investigator: Bharat Mocherla
Phone: 310-993-9118
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Lexington, Kentucky 40503
Principal Investigator: Gregory Cooper
Phone: 859-260-4330
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Lomita, California 90717
Principal Investigator: Marina Raikhel
Phone: 310-373-8120
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Memphis, Tennessee 38119
Principal Investigator: Lora McGill
Phone: 901-843-1045
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Methuen, Massachusetts 01844
Principal Investigator: Michael McCartney
Phone: 978-655-7155
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Miami, Florida 33137
Principal Investigator: Marc Agronin
Phone: 305-751-8626
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New Haven, Connecticut 06510
Principal Investigator: David Russell
Phone: 203-401-4300
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New York, New York 10016
Principal Investigator: Martin Sadowski
Phone: 212-263-7744
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
Principal Investigator: Carl Griffin
Phone: 405-602-3939
Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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Orlando, Florida 32806
Principal Investigator: Craig Curtis
Phone: 407-426-9299
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Palm Beach Gardens, Florida 33418
Principal Investigator: Michael Tuchman
Phone: 561-282-5541
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1775 West Dempster Street
Park Ridge, Illinois 60068
(847) 723-2210
Principal Investigator: Darren Gitelman
Phone: 847-720-6464
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350 W Thomas Rd
Phoenix, Arizona 85013
(602) 406-3000
Principal Investigator: Jiong Shi
Phone: 602-406-6262
St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
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Plains, Pennsylvania 18705
Principal Investigator: Mario Cornacchione
Phone: 570-207-3945
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Plymouth, Massachusetts 02360
Principal Investigator: Donald Marks
Phone: 508-746-5060
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345 Blackstone Blvd
Providence, Rhode Island 02906
(401) 455-6200
Principal Investigator: Stephen Salloway
Phone: 401-455-6203
Butler Hospital Founded in 1844, Butler Hospital is the state's only non-profit, free-standing psychiatric hospital...
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Raleigh, North Carolina 27607
Principal Investigator: Michael Bowman
Phone: 919-782-3456
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Richmond, Virginia 23294
Principal Investigator: John Scott
Phone: 804-672-2995
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Rochester, Minnesota 55905
Principal Investigator: David Knopman
Phone: 763-588-0661
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Saint Louis, Missouri 63110
Principal Investigator: Barbara Snider
Phone: 314-747-2107
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San Francisco, California 94143
Principal Investigator: Adam Boxer
Phone: 415-476-8333
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Sherman Oaks, California 91403
Principal Investigator: Thomas Shiovitz
Phone: 818-990-2671
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Simi Valley, California 93065
Principal Investigator: Brock Summers
Phone: 818-631-7489
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Tampa, Florida
Principal Investigator: Amanda Smith
Phone: 813-974-4355
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Tampa, Florida
Principal Investigator: Cynthia Huffman
Phone: 813-877-8839
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The Villages, Florida 32162
Principal Investigator: David Subich
Phone: 352-261-0901
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Toms River, New Jersey 08757
Principal Investigator: Sanjiv Sharma
Phone: 732-341-9500
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 444-2000
Principal Investigator: Raymond Turner
Phone: 202-687-7337
Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...
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West Palm Beach, Florida 33407
Principal Investigator: Walter Martinez
Phone: 561-845-0500
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Weston, Florida 33331
Principal Investigator: Po-Heng Tsai
Phone: 954-659-5670
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Wichita, Kansas 67214
Principal Investigator: Paul Murphy
Phone: 316-291-4774
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