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

Primary Purpose

Alzheimer's Disease

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aducanumab (BIIB037)
Aducanumab (BIIB037)
Placebo
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring BIIB037, Aducanumab

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Hospital and Medical Center
  • Center for Neurosciences
  • Neurology Center of North Orange County
  • Senior Clinical Trials, Inc.
  • Torrance Clinical Research Institute, Inc.
  • University of California - Los Angeles
  • UCSF - Memory and Aging Center
  • California Neuroscience Research Medical Group Inc.
  • Southern California Research LLC
  • Institute for Neurodegenerative Disorders
  • Georgetown University Hospital
  • Brain Matters Research, Inc.
  • Neuropsychiatric Research Center of Southwest Florida
  • Jacksonville Center for Clinical Research
  • University of Miami
  • Miami Jewish Health Systems
  • Compass Research Main
  • Palm Beach Neurological Center
  • Stedman Clinical Trials, LLC
  • USF Health Byrd Institute
  • Meridien Research
  • Compass Research Main
  • Premiere Research Institute
  • Cleveland Clinic Florida - Weston
  • Alexian Brothers Neurosciences Institute
  • Advocate Lutheran General Hospital
  • Fort Wayne Neurological Center
  • Indiana University School of Medicine
  • University of Kansas Medical Center Research Institute, Inc.
  • Via Christi Research, a division of Via Christi Hospitals Wichita, Inc.
  • Baptist Health Lexington
  • Brigham & Women's Hosp End/Dbt
  • Beth Israel Deaconess Medical Center
  • ActivMed Practices & Research
  • Donald S. Marks, M.D., P.C.
  • Mayo Clinic
  • Washington University
  • Las Vegas Medical research
  • Advanced Memory Research Institute of NJ, PC
  • Albany Medical College
  • New York University Medical Center PRIME
  • University of Rochester
  • ANI Neurology, PLLC d/b/a Alzheimer's Memory Center
  • Raleigh Neurology Associates, P.A.
  • Cleveland Clinic
  • Lynn Health Science Institute
  • The Clinical Trial Center, LLC
  • University of Pittsburgh
  • Northeastern Pennsylvania Memory and Alzheimer's Center
  • Rhode Island Mood & Memory Research Institute
  • Butler Hospital
  • Medical University of South Carolina (MUSC)
  • Neurology Clinic, PC
  • University of Tennessee Medical Center. Knoxville
  • Clinical Neuroscience Solutions, Inc.
  • UT Southwestern Medical Center at Dallas
  • Baylor College of Medicine
  • National Clinical Research Inc.-Richmond
  • Medical College of Wisconsin, Inc.
  • St Vincent's Hospital Sydney
  • Central Coast Neurosciences Research, Gosford
  • Central Coast Neurosciences Research
  • KARA Institute for Neurological Diseases
  • Calvary Mater Newcastle
  • The Prince Charles Hospital
  • Royal Brisbane and Women's Hospital
  • Toowoomba Base Hospital
  • Box Hill Hospital
  • Austin Hospital
  • Royal Melbourne Hospital
  • Neurodegenerative Disorders Research
  • LKH - Universitaetsklinikum Graz
  • Christian-Doppler-Klinik - Universitätsklinikum Salzburg
  • Heritage Medical Research Clinic
  • The Medical Arts Health Research Group
  • UBC Hospital
  • Toronto Memory Program (Neurology Research Inc.)
  • Toronto Sunnybrook Hospital
  • The Montreal Neurological Institute
  • McGill Centre for Studies in Aging
  • CHU de Quebec - Hôpital de l' Enfant Jésus
  • CCBR - Ballerup - DK
  • Rigshospitalet
  • CCBR - Vejle - DK
  • CCBR - Ålborg - DK
  • CHU Strasbourg - Hôpital Hautepierre
  • Hopital Louis Pasteur Colmar
  • Groupe Hospitalier Pellegrin - Hôpital Pellegrin
  • CHU Reims - Hôpital Maison Blanche
  • Hopital Neurologique Pierre Wertheimer
  • Groupe hospitalier Broca - La Rochefoucauld - La Collégiale
  • Groupe Hospitalier Pitie-Salpetriere
  • Praxis Dr. Scholz
  • Aerztliche Gemeinschaftspraxis
  • Neuro MVZ Stuttgart
  • Klinikum der Johann Wolfgang Goethe-Universitaet
  • Praxis Dr. med. Bergmann
  • Neurologische Gemeinschaftspraxis Kassel
  • Klinische Forschung Hannover-Mitte GmbH
  • Universitaetsklinikum Aachen AOeR
  • Universitaetsklinikum Bonn AoeR
  • Universitaetsklinikum Koeln
  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
  • Azienda Ospedaliero Universitaria Ospedali Riuniti
  • Fondazione Istituto G.Giglio di Cefalù
  • Azienda Ospedaliera Ospedali Riuniti di Bergamo
  • Azienda Ospedaliera Spedali Civili di Brescia
  • Azienda Ospedaliero Universitaria San Martino
  • Ospedale San Raffaele
  • Casa di Cura del Policlinico
  • Azienda Ospedaliera Universitaria "Federico II"
  • Seconda Università degli Studi di Napoli
  • Azienda Ospedaliero Universitaria Pisana
  • Policlinico Universitario Agostino Gemelli
  • Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona
  • A.O.U. Senese Policlinico Santa Maria alle Scotte
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Inha University Hospital
  • Seoul National University Bundang Hospital
  • Gachon University Gil Medical Center
  • Asan Medical Center
  • Samsung Medical Center
  • Konkuk University Medical Center
  • Hospital Professor Doutor Fernando Fonseca, E.P.E.
  • Hospital de Braga
  • Centro Hospitalar e Universitário de Coimbra E.P.E
  • CUF Alvalade
  • Hospital Beatriz Ângelo
  • Campus Neurologico Senior
  • Policlinica Guipuzcoa
  • Hospital de Cruces
  • Fundacio ACE
  • Hospital Clinic i Provincial de Barcelona
  • Hospital de la Santa Creu i Sant Pau
  • Clinica Ruber
  • Hospital Universitario Dr. Peset
  • Hospital Universitari i Politecnic La Fe
  • Changhua Christian Hospital
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung Chang Gung Memorial Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Chang Gung Memorial Hospital, Linkou
  • Southmead Hospital
  • Re:Cognition Health Ltd
  • Charing Cross Hospital
  • The National Hospital for Neurology and Neurosurgery Centre
  • Salford Royal
  • The University of Edinburgh
  • Manchester Royal Infirmary
  • The RICE Centre
  • Glasgow Memory Clinic Ltd
  • Stobhill ACH Hospital
  • Ninewells Hospital
  • Newcastle University
  • Kingshill Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low Dose

High Dose

Arm Description

Monthly intravenous (IV) infusion

Monthly intravenous (IV) infusion

Outcomes

Primary Outcome Measures

Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Score at Week 78
CDR-SB integrates assessments from 3 domains of cognition (memory, orientation, judgment/problem-solving) and 3 domains of function (community affairs, home/hobbies, personal care). Following caregiver interview and systematic patient examination, the rater assigns a score describing the participant's current performance level in each of these domains of life functioning. Prespecified severity anchors range from none = 0, questionable = 0.5, mild = 1, moderate = 2 to severe = 3 (the personal care domain omits the 0.5 score). "Sum of boxes" scoring methodology sums the score for each of the 6 domains and provides a value ranging from 0 to 18 that can change in increments of 0.5 or greater. Higher scores indicate greater disease severity. Mixed model for repeated measures (MMRM) analysis was used to analyze change from baseline in CDR-SB. A positive change from baseline indicates clinical decline.

Secondary Outcome Measures

Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 78
The MMSE is a widely used performance-based test of global cognitive status. It consists of 11 tasks that assess orientation, word recall, attention and calculation, language abilities, and visuospatial functions. The scores from the 11 tests are combined to obtain the total score, which ranges from 0 to 30, with lower scores over time indicating increasing cognitive impairment. MMRM analysis was used to analyze change from baseline in MMSE. A negative change from baseline indicates clinical decline.
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (13 Items) (ADAS-Cog 13) Score at Week 78
ADAS-Cog13 comprises both cognitive tasks and clinical ratings of cognitive performance. The scale items capture word recall, ability to follow commands, the ability to correctly copy or draw an image, naming, the ability to interact with everyday objects, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure for delayed word recall and concentration/distractibility. The total score ranges from 0 to 85. An increase in score over time indicates increasing cognitive impairment. MMRM analysis was used to analyze change from baseline in ADAS-Cog 13. A positive change from baseline indicates clinical decline.
Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment Version) (ADCS-ADL-MCI) Score at Week 78
The ADCS-ADL-MCI consists of 17 instrumental items (e.g., shopping, preparing meals, using household appliances) and 1 basic item (getting dressed). Ratings reflect caregiver observations about the patient's actual functioning over the previous month and provide an assessment of change in the functional state of the participant over time. The total score ranges from 0 to 53, with lower values over time reflecting functional deterioration. MMRM analysis was used to analyze change from baseline in ADAS-ADL-MCI. A negative change from baseline indicates clinical decline.

Full Information

First Posted
June 18, 2015
Last Updated
August 9, 2021
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT02477800
Brief Title
221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease
Acronym
ENGAGE
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Study was discontinued based on futility analysis done and not based on safety concerns. Follow-up visits and closing out study activities are completed
Study Start Date
August 13, 2015 (Actual)
Primary Completion Date
August 8, 2019 (Actual)
Study Completion Date
August 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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].

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
BIIB037, Aducanumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1653 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose
Arm Type
Experimental
Arm Description
Monthly intravenous (IV) infusion
Arm Title
High Dose
Arm Type
Experimental
Arm Description
Monthly intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Aducanumab (BIIB037)
Intervention Description
Low dose
Intervention Type
Drug
Intervention Name(s)
Aducanumab (BIIB037)
Intervention Description
High dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Score at Week 78
Description
CDR-SB integrates assessments from 3 domains of cognition (memory, orientation, judgment/problem-solving) and 3 domains of function (community affairs, home/hobbies, personal care). Following caregiver interview and systematic patient examination, the rater assigns a score describing the participant's current performance level in each of these domains of life functioning. Prespecified severity anchors range from none = 0, questionable = 0.5, mild = 1, moderate = 2 to severe = 3 (the personal care domain omits the 0.5 score). "Sum of boxes" scoring methodology sums the score for each of the 6 domains and provides a value ranging from 0 to 18 that can change in increments of 0.5 or greater. Higher scores indicate greater disease severity. Mixed model for repeated measures (MMRM) analysis was used to analyze change from baseline in CDR-SB. A positive change from baseline indicates clinical decline.
Time Frame
Baseline, Week 78
Secondary Outcome Measure Information:
Title
Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 78
Description
The MMSE is a widely used performance-based test of global cognitive status. It consists of 11 tasks that assess orientation, word recall, attention and calculation, language abilities, and visuospatial functions. The scores from the 11 tests are combined to obtain the total score, which ranges from 0 to 30, with lower scores over time indicating increasing cognitive impairment. MMRM analysis was used to analyze change from baseline in MMSE. A negative change from baseline indicates clinical decline.
Time Frame
Baseline, Week 78
Title
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (13 Items) (ADAS-Cog 13) Score at Week 78
Description
ADAS-Cog13 comprises both cognitive tasks and clinical ratings of cognitive performance. The scale items capture word recall, ability to follow commands, the ability to correctly copy or draw an image, naming, the ability to interact with everyday objects, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure for delayed word recall and concentration/distractibility. The total score ranges from 0 to 85. An increase in score over time indicates increasing cognitive impairment. MMRM analysis was used to analyze change from baseline in ADAS-Cog 13. A positive change from baseline indicates clinical decline.
Time Frame
Baseline, Week 78
Title
Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment Version) (ADCS-ADL-MCI) Score at Week 78
Description
The ADCS-ADL-MCI consists of 17 instrumental items (e.g., shopping, preparing meals, using household appliances) and 1 basic item (getting dressed). Ratings reflect caregiver observations about the patient's actual functioning over the previous month and provide an assessment of change in the functional state of the participant over time. The total score ranges from 0 to 53, with lower values over time reflecting functional deterioration. MMRM analysis was used to analyze change from baseline in ADAS-ADL-MCI. A negative change from baseline indicates clinical decline.
Time Frame
Baseline, Week 78

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Center for Neurosciences
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
Facility Name
Neurology Center of North Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Senior Clinical Trials, Inc.
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Torrance Clinical Research Institute, Inc.
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
University of California - Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCSF - Memory and Aging Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
California Neuroscience Research Medical Group Inc.
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Southern California Research LLC
City
Simi Valley
State/Province
California
ZIP/Postal Code
93065
Country
United States
Facility Name
Institute for Neurodegenerative Disorders
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Facility Name
Brain Matters Research, Inc.
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Neuropsychiatric Research Center of Southwest Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Miami Jewish Health Systems
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Compass Research Main
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Palm Beach Neurological Center
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Stedman Clinical Trials, LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
USF Health Byrd Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33616
Country
United States
Facility Name
Meridien Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
Compass Research Main
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
Premiere Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Cleveland Clinic Florida - Weston
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Alexian Brothers Neurosciences Institute
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Advocate Lutheran General Hospital
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Fort Wayne Neurological Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kansas Medical Center Research Institute, Inc.
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Via Christi Research, a division of Via Christi Hospitals Wichita, Inc.
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Brigham & Women's Hosp End/Dbt
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
ActivMed Practices & Research
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
Donald S. Marks, M.D., P.C.
City
Plymouth
State/Province
Massachusetts
ZIP/Postal Code
02360
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Las Vegas Medical research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
Advanced Memory Research Institute of NJ, PC
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
New York University Medical Center PRIME
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
ANI Neurology, PLLC d/b/a Alzheimer's Memory Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28270
Country
United States
Facility Name
Raleigh Neurology Associates, P.A.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607-6010
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
The Clinical Trial Center, LLC
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Northeastern Pennsylvania Memory and Alzheimer's Center
City
Plains
State/Province
Pennsylvania
ZIP/Postal Code
18705
Country
United States
Facility Name
Rhode Island Mood & Memory Research Institute
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02915
Country
United States
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Medical University of South Carolina (MUSC)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Neurology Clinic, PC
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38108
Country
United States
Facility Name
University of Tennessee Medical Center. Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
UT Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
National Clinical Research Inc.-Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Medical College of Wisconsin, Inc.
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53266
Country
United States
Facility Name
St Vincent's Hospital Sydney
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Central Coast Neurosciences Research, Gosford
City
East Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
Central Coast Neurosciences Research
City
Erina
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
KARA Institute for Neurological Diseases
City
North Ryde
State/Province
New South Wales
ZIP/Postal Code
2113
Country
Australia
Facility Name
Calvary Mater Newcastle
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
The Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Facility Name
Toowoomba Base Hospital
City
Toowoomba
State/Province
Queensland
ZIP/Postal Code
4350
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Neurodegenerative Disorders Research
City
West Perth
State/Province
Western Australia
ZIP/Postal Code
6005
Country
Australia
Facility Name
LKH - Universitaetsklinikum Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Christian-Doppler-Klinik - Universitätsklinikum Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Heritage Medical Research Clinic
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada
Facility Name
The Medical Arts Health Research Group
City
Penticton
State/Province
British Columbia
ZIP/Postal Code
V2A 5C8
Country
Canada
Facility Name
UBC Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada
Facility Name
Toronto Memory Program (Neurology Research Inc.)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3B 2S7
Country
Canada
Facility Name
Toronto Sunnybrook Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
The Montreal Neurological Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
McGill Centre for Studies in Aging
City
Verdun
State/Province
Quebec
ZIP/Postal Code
H4H 1R3
Country
Canada
Facility Name
CHU de Quebec - Hôpital de l' Enfant Jésus
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
CCBR - Ballerup - DK
City
Ballerup
ZIP/Postal Code
2750
Country
Denmark
Facility Name
Rigshospitalet
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
CCBR - Vejle - DK
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
CCBR - Ålborg - DK
City
Ålborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
CHU Strasbourg - Hôpital Hautepierre
City
Strasbourg Cedex
State/Province
Bas Rhin
ZIP/Postal Code
67098
Country
France
Facility Name
Hopital Louis Pasteur Colmar
City
Strasbourg
State/Province
Bas Rhin
ZIP/Postal Code
67091
Country
France
Facility Name
Groupe Hospitalier Pellegrin - Hôpital Pellegrin
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33076
Country
France
Facility Name
CHU Reims - Hôpital Maison Blanche
City
Reims
State/Province
Marne
ZIP/Postal Code
51092
Country
France
Facility Name
Hopital Neurologique Pierre Wertheimer
City
Bron Cedex
State/Province
Rhone
ZIP/Postal Code
69677
Country
France
Facility Name
Groupe hospitalier Broca - La Rochefoucauld - La Collégiale
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Groupe Hospitalier Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Praxis Dr. Scholz
City
Boeblingen
State/Province
Baden Wuerttemberg
ZIP/Postal Code
71034
Country
Germany
Facility Name
Aerztliche Gemeinschaftspraxis
City
Ostfildern
State/Province
Baden Wuerttemberg
ZIP/Postal Code
73760
Country
Germany
Facility Name
Neuro MVZ Stuttgart
City
Stuttgart
State/Province
Baden Wuerttemberg
ZIP/Postal Code
70182
Country
Germany
Facility Name
Klinikum der Johann Wolfgang Goethe-Universitaet
City
Frankfurt
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
Facility Name
Praxis Dr. med. Bergmann
City
Neuburg
State/Province
Bayern
ZIP/Postal Code
86633
Country
Germany
Facility Name
Neurologische Gemeinschaftspraxis Kassel
City
Kassel
State/Province
Hessen
ZIP/Postal Code
34121
Country
Germany
Facility Name
Klinische Forschung Hannover-Mitte GmbH
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30159
Country
Germany
Facility Name
Universitaetsklinikum Aachen AOeR
City
Aachen
State/Province
Nordrhein Westfalen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Universitaetsklinikum Bonn AoeR
City
Bonn
State/Province
Nordrhein Westfalen
ZIP/Postal Code
53127
Country
Germany
Facility Name
Universitaetsklinikum Koeln
City
Cologne
State/Province
Nordrhein Westfalen
ZIP/Postal Code
53105
Country
Germany
Facility Name
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti
City
Torrette Di Ancona
State/Province
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Fondazione Istituto G.Giglio di Cefalù
City
Cefalù
State/Province
Palermo
ZIP/Postal Code
90015
Country
Italy
Facility Name
Azienda Ospedaliera Ospedali Riuniti di Bergamo
City
Bergamo
ZIP/Postal Code
24100
Country
Italy
Facility Name
Azienda Ospedaliera Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25100
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Casa di Cura del Policlinico
City
Milano
ZIP/Postal Code
20144
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria "Federico II"
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Seconda Università degli Studi di Napoli
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona
City
Salerno
ZIP/Postal Code
84131
Country
Italy
Facility Name
A.O.U. Senese Policlinico Santa Maria alle Scotte
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Research Site
City
Chiba-Shi
State/Province
Chiba-Ken
ZIP/Postal Code
263-0043
Country
Japan
Facility Name
Research Site
City
Inzai-shi
State/Province
Chiba-Ken
Country
Japan
Facility Name
Research Site
City
Kurume-shi
State/Province
Fukuoka-ken
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Research Site
City
Aizuwakamatsu-shi
State/Province
Fukushima-Ken
ZIP/Postal Code
965-8585
Country
Japan
Facility Name
Research Site
City
Asahikawa-shi
State/Province
Hokkaido
ZIP/Postal Code
070-8644
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
006-8555
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
064-8570
Country
Japan
Facility Name
Research Site
City
Atsugi-shi
State/Province
Kanagawa-Ken
ZIP/Postal Code
243-8551
Country
Japan
Facility Name
Research Site
City
Kamakura-shi
State/Province
Kanagawa-Ken
ZIP/Postal Code
247-8533
Country
Japan
Facility Name
Research Site
City
Kawasaki-Shi
State/Province
Kanagawa-Ken
ZIP/Postal Code
211-8533
Country
Japan
City
Yokohama-shi
State/Province
Kanagawa-ken
ZIP/Postal Code
223-0059
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
State/Province
Kanagawa-Ken
ZIP/Postal Code
225-0013
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
State/Province
Kanagawa-Ken
ZIP/Postal Code
225-0025
Country
Japan
Facility Name
Research Site
City
Kyoto-shi
State/Province
Kyoto-Fu
ZIP/Postal Code
616-8255
Country
Japan
Facility Name
Research Site
City
Nagaoka-shi
State/Province
Niigata-Ken
ZIP/Postal Code
940-2081
Country
Japan
Facility Name
Research Site
City
Iruma-gun
State/Province
Saitama-Ken
ZIP/Postal Code
350-0495
Country
Japan
Facility Name
Research Site
City
Kasukabe-shi
State/Province
Saitama-Ken
ZIP/Postal Code
344-0036
Country
Japan
Facility Name
Research Site
City
Bunkyo-ku
State/Province
Tokyo-To
ZIP/Postal Code
113-0034
Country
Japan
Facility Name
Research Site
City
Shinjuku-ku (I)
State/Province
Tokyo-To
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Research Site
City
Shinjuku-ku
State/Province
Tokyo-To
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Research Site
City
Ota-ku
State/Province
Tokyo
ZIP/Postal Code
143-8541
Country
Japan
Facility Name
Research Site
City
Yamagata-shi
State/Province
Yamagata-Ken
ZIP/Postal Code
990-0834
Country
Japan
Facility Name
Research Site
City
Itabashi-ku
ZIP/Postal Code
173-0015
Country
Japan
Facility Name
Research Site
City
Itabashi-ku
ZIP/Postal Code
173-8610
Country
Japan
Facility Name
Research Site
City
Kiyose-shi
Country
Japan
Facility Name
Research Site
City
Kodaira-shi
ZIP/Postal Code
187-8551
Country
Japan
Facility Name
Inha University Hospital
City
Incheon
State/Province
Gyeonggi-do
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of
Facility Name
Hospital Professor Doutor Fernando Fonseca, E.P.E.
City
Amadora
ZIP/Postal Code
2720-276
Country
Portugal
Facility Name
Hospital de Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Centro Hospitalar e Universitário de Coimbra E.P.E
City
Coimbra
ZIP/Postal Code
3040-278
Country
Portugal
Facility Name
CUF Alvalade
City
Lisboa
ZIP/Postal Code
1600-618
Country
Portugal
Facility Name
Hospital Beatriz Ângelo
City
Loures
ZIP/Postal Code
2674-514
Country
Portugal
Facility Name
Campus Neurologico Senior
City
Torres Vedras
ZIP/Postal Code
2560-280
Country
Portugal
Facility Name
Policlinica Guipuzcoa
City
San Sebastian
State/Province
Guipuzcoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hospital de Cruces
City
Barakaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Fundacio ACE
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Clinica Ruber
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario Dr. Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Changhua Christian Hospital
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital, Linkou
City
Taoyuan County
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Southmead Hospital
City
Bristol
State/Province
Avon
ZIP/Postal Code
BS16 1LE
Country
United Kingdom
Facility Name
Re:Cognition Health Ltd
City
London
State/Province
Greater London
ZIP/Postal Code
W1G 9JF
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
The National Hospital for Neurology and Neurosurgery Centre
City
London
State/Province
Greater London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Facility Name
Salford Royal
City
Salford
State/Province
Greater Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
The University of Edinburgh
City
Edinburgh
State/Province
Lothian Region
ZIP/Postal Code
EH8 9YL
Country
United Kingdom
Facility Name
Manchester Royal Infirmary
City
Blackburn
State/Province
Merseyside
ZIP/Postal Code
BB3 2HH
Country
United Kingdom
Facility Name
The RICE Centre
City
Bath
State/Province
Somerset
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
Glasgow Memory Clinic Ltd
City
Glasgow
State/Province
Strathclyde
ZIP/Postal Code
G20 0XA
Country
United Kingdom
Facility Name
Stobhill ACH Hospital
City
Glasgow
State/Province
Strathclyde
ZIP/Postal Code
G21 3UW
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
State/Province
Tayside Region
ZIP/Postal Code
DD2 1GZ
Country
United Kingdom
Facility Name
Newcastle University
City
Newcastle upon Tyne
State/Province
Tyne & Wear
ZIP/Postal Code
NE4 5PL
Country
United Kingdom
Facility Name
Kingshill Research Centre
City
Chippenham
State/Province
Wiltshire
ZIP/Postal Code
SN15 1GG
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34807243
Citation
Salloway S, Chalkias S, Barkhof F, Burkett P, Barakos J, Purcell D, Suhy J, Forrestal F, Tian Y, Umans K, Wang G, Singhal P, Budd Haeberlein S, Smirnakis K. Amyloid-Related Imaging Abnormalities in 2 Phase 3 Studies Evaluating Aducanumab in Patients With Early Alzheimer Disease. JAMA Neurol. 2022 Jan 1;79(1):13-21. doi: 10.1001/jamaneurol.2021.4161.
Results Reference
derived

Learn more about this trial

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

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