221AD302 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:September 30, 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
104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
Principal Investigator: Jay Rubin
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: David Geldmacher
Phone: 205-996-3679
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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3924 9th Avenue West
Bradenton, Florida 34205
Principal Investigator: William McElveen
Phone: 941-708-0005
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: Brian Ott
Phone: 401-444-6440
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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2919 Swann Avenue
Tampa, Florida 33609
813-353-9613
Principal Investigator: Susan Steen
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Allentown, Pennsylvania 18104
Principal Investigator: Paul Gross
Phone: 610-820-0342
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Atlanta, Georgia 30329
Principal Investigator: Allan Levey
Phone: 404-727-7220
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Atlantis, Florida 33462
Principal Investigator: Mark Goldstein
Phone: 561-968-2933
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Jonathan Woodcock
Phone: 303-724-7863
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Austin, Texas 78757
Principal Investigator: Jaron Winston
Phone: 512-407-8628
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115 Mill St
Belmont, Massachusetts 02478
(617) 855-2000
Principal Investigator: Brent Forester
Phone: 617-855-3622
McLean Hospital McLean Hospital is a comprehensive psychiatric hospital committed to providing easy access to...
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Bennington, Vermont 05201
Principal Investigator: Cynthia Murphy
Phone: 802-447-1409
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Boca Raton, Florida 33431
Principal Investigator: James Galvin
Phone: 561-297-4806
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100 Augustijnslei
Brasschaat, 2930
Principal Investigator: Karine Geens
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Brooksville, Florida
Principal Investigator: Kelli Max
Phone: 352-597-7578
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Columbus, Georgia 31909
Principal Investigator: Jonathan Liss
Phone: 706-653-8455
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Decatur, Georgia 30033
Principal Investigator: Marshall Nash
Phone: 404-475-0552
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Deerfield Beach, Florida 33064
Principal Investigator: Jose De La Gandara
Phone: 954-786-7331
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6775 Bobcat Way
Dublin, Ohio 43017
Principal Investigator: Douglas Scharre
Phone: 614-293-8531
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Fairfield, Connecticut 06824
Principal Investigator: Dario Zagar
Phone: 203-333-1151
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Hattiesburg, Mississippi 39401
Principal Investigator: Ronald Schwartz
Phone: 601-268-5620
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Hollywood, Florida 33021
Principal Investigator: Harvey Schwartz
Phone: 954-981-3850
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Houston, Texas 77074
Principal Investigator: Djamchid Lotfi
Phone: 713-484-6947
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Houston, Texas 77030
Principal Investigator: Joseph Masdeu
Phone: 713-441-1150
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Indianapolis, Indiana 46256
Principal Investigator: Kristi George
Phone: 317-537-6060
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Irvine, California 92607
Principal Investigator: Aimee Pierce
Phone: 949-824-3250
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4500 San Pablo Rd S
Jacksonville, Florida 32224
(904) 953-2000
Principal Investigator: Neill Graff-Radford
Phone: 904-953-7103
Mayo Clinic Florida Thousands of people come to Mayo Clinic in Jacksonville, Fla., annually for...
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Las Vegas, Nevada 89106
Principal Investigator: Charles Bernick
Phone: 702-483-6026
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Latham, New York 12110
Principal Investigator: Keith Edwards
Phone: 518-785-1000
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Lawrenceville, New Jersey 08648
Principal Investigator: Arnold Witte
Phone: 609-895-0735
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Long Beach, California 85013
Principal Investigator: Laja Ibraheem
Phone: 562-426-5222
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Los Angeles, California 90033
Principal Investigator: Lon Schneider
Phone: 323-442-7600
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: Christopher Van Dyck
Phone: 203-764-8100
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New York, New York 10021
Principal Investigator: Michael Lin
Phone: 212-746-2441
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New York, New York 10029
Principal Investigator: Amy Aloysi
Phone: 347-326-2178
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Newport Beach, California 92658
Principal Investigator: William Shankle
Phone: 949-478-8858
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Newton, Massachusetts 02459
Principal Investigator: Paul Solomon
Phone: 617-699-6927
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North Charleston, South Carolina 29406
Principal Investigator: Jacobo Mintzer
Phone: 843-724-2302
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Norwalk, Connecticut 06851
Principal Investigator: Bart Sloan
Phone: 203-838-0070
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Oceanside, California 92056
Principal Investigator: Sheryy Soefje
Phone: 760-758-2222
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Orlando, Florida 32806
Principal Investigator: Linda Harper
Phone: 407-425-5100
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Oxnard, California
Principal Investigator: James Sutton
Phone: 805-278-4148
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Philadelphia, Pennsylvania 19104
Principal Investigator: David Wolk
Phone: 215-746-3949
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Phoenix, Arizona 85006
Principal Investigator: David Weidman
Phone: 623-832-6500
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Phoenix, Arizona 85004
Principal Investigator: Stephen Flitman
Phone: 602-274-9500
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Portsmouth, New Hampshire 03801
Principal Investigator: Marc Shay
Phone: 978-372-7252
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Redlands, California 92374
Principal Investigator: Donald Anderson
Phone: 909-792-9007
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Salt Lake City, Utah 84132
Principal Investigator: Richard King
Phone: 801-261-8950
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San Diego, California 92103
Principal Investigator: Stephen Thein
Phone: 619-294-4302
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San Diego, California 92103
Principal Investigator: James Lohr
Phone: 619-543-6102
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45 Castro Street
San Francisco, California 94114
(415) 600-6000
Principal Investigator: Alireza Atri
Phone: 415-600-5555
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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Santa Ana, California 92705
Principal Investigator: John Duffy
Phone: 714-542-3008
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Santa Rosa, California 95403
Principal Investigator: Marc Bernstein
Phone: 707-521-3814
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
Principal Investigator: Suman Jayadev
Phone: 206-221-2930
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Spokane, Washington 99202
Principal Investigator: David Greeley
Phone: 509-343-3710
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Principal Investigator: Sharon Sha
Phone: 650-725-6563
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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Sun City, Arizona 85351
Principal Investigator: Edward Zamrini
Phone: 623-832-6530
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Thornton, Colorado 80233
Principal Investigator: Ronald Murray
Phone: 303-771-9000
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1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
(336) 768-8062
Principal Investigator: Giles Crowell
Phone: 336-794-8165
PMG Research of Winston-Salem PMG Research of Winston-Salem, founded in 1979, occupies a 10,000 square...
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Winston-Salem, North Carolina 27157
Principal Investigator: Kaycee Sink
Phone: 336-713-8558
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