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221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease (EMERGE)

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 Aducanumab, BIIB037

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

  • University of Alabama at Birmingham
  • Banner Alzheimer's Institute
  • Xenoscience Inc.
  • Banner Sun Health Research Institute
  • Institute for Memory Impairments
  • Renewal Behavioral Health
  • USC Keck School of Medicine
  • Hoag Memorial Hospital Presbyterian
  • Excell Research, Inc.
  • Pacific Neuroscience Medical Group
  • Anderson Clinical Research
  • Pacific Research Network
  • University of California San Diego Medical Center
  • California Pacific Medical Center
  • Syrentis Clinical Research
  • St Joseph Heritage Healthcare
  • Stanford University Medical Center
  • University Of Colorado Denver
  • IMMUNOe International Research Centers
  • Associated Neurologists of Southern Connecticut, PC
  • Yale University School Of Medicine
  • Research Center for Clinical Studies, Inc.
  • JEM Research Institute
  • Bradenton Research Center, Inc.
  • Meridien Research
  • Quantum Laboratories Inc.
  • Infinity Clinical Research, LLC
  • Mayo Clinic in Florida
  • Renstar Medical Research
  • Clinical Neuroscience Solutions, Inc.
  • Axiom Clinical Research of Florida
  • Emory University Cognitive Neurology Clinic & ADRC
  • Medical Research Health and Education Foundation, Inc
  • NeuroStudies.net, LLC
  • Josephson, Wallack, Munshower Neurology, PC
  • McLean Hospital
  • Boston Center for Memory
  • Hattiesburg Clinic, PA
  • Cleveland Clinic Lou Ruvo Center for Brain Health
  • ActivMed Practices & Research
  • AdvanceMed Research
  • Empire Neurology, PC
  • Weill Cornell Medical College-New York Presbyterian Hospital
  • Mount Sinai School of Medicine
  • PMG Research of Winston-Salem, LLC
  • Wake Forest Baptist Health
  • Ohio State University Medical Center
  • Lehigh Center for Clinical Research, LLC
  • Penn Memory Center
  • Rhode Island Hospital
  • Roper St. Francis Healthcare
  • Senior Adult Specialty Research
  • The Methodist Hospital Research Institute
  • Clinical Trial Network
  • University of Utah Health Sciences Center
  • Clinical Neuroscience Research Association, Inc
  • University of Washington Medical Center
  • Northwest Neurological, PLLC
  • A.Z. Klina
  • AZ Sint-Jan Brugge
  • Universitair Ziekenhuis Brussel
  • Centre Neurologique & de Réadaptation Fonctionnelle
  • Universitair Ziekenhuis Gent
  • AZ Groeninge - Campus Kennedylaan
  • UZ Leuven
  • AZ Delta
  • Health Research.
  • Health Research
  • True North Clinical Research - Halifax Inc.
  • True North Clinical Research Kentville, Inc
  • JBN Medical Diagnostic Services Inc.
  • St. Joseph's HC- Parkwood Institute
  • Bruyere Continuing Care
  • Kawartha Regional Memory Clinic
  • Toronto Western Hospital
  • Recherches Neuro-Hippocampe Inc.
  • Recherche Sepmus, Inc.
  • DIEX Recherche Sherbrooke Inc.
  • Douglas Hospital Research Centre
  • Terveystalo Kamppi
  • Itä-Suomen yliopisto, Aivotutkimusyksikkö
  • CRST, Clinical Research Services Turku
  • Hôpital de la Timone
  • CHU de Toulouse - Hôpital Purpan
  • Centre de Recherche Clinique du Gérontopôle - Cité de la Santé
  • Hôpital Gui de Chauliac
  • CHU Rennes - Hopital Pontchaillou
  • CHU Nantes - Hopital Nord Laënnec
  • Hopital Roger Salengro - CHU Lille
  • Hôpital des Charpennes
  • Hôpital Fernand Widal
  • Bezirkskrankenhaus Guenzburg
  • ISPG - Institut fuer Studien zur Psychischen Gesundheit
  • Nervenfachaerztlichen Gemeinschaftspraxis Ulm
  • Universitaetsklinikum Ulm
  • Klinik Hohe Warte Bayreuth
  • Institut fuer Schlaganfall- und Demenzforschung (ISD)
  • Klinikum rechts der Isar der TU Muenchen
  • Neuropraxis Muenchen Sued
  • Neuro Centrum Odenwald
  • Universitaetsklinikum Duesseldorf AoeR
  • Universitaetsklinikum Muenster
  • Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung
  • Schwerpunktpraxis fuer Neurologie, Psychiatrie und Klinische Studien
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
  • Klinikum Chemnitz gGmbH
  • Kopfzentrum Leipzig
  • Klinikum Altenburger Land GmbH
  • emovis GmbH
  • Neurologie im Tempelhofer Hafen
  • Ospedale degli Infermi
  • Azienda Ospedaliera Card. G. Panico
  • ASST di Monza
  • Fondazione IRCCS Istituto Neurologico Carlo Besta
  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
  • Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
  • Fondazione Santa Lucia IRCCS
  • Umberto I Pol. di Roma-Università di Roma La Sapienza
  • 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
  • Research Site
  • Research Site
  • Alzheimer Research Center
  • Erasmus Medisch Centrum
  • Podlaskie Centrum Psychogeriatrii
  • PALLMED Sp. z o.o.
  • Uniwersyteckie Centrum Kliniczne
  • Novo-Med Zielinski i wspolnicy Sp. j.
  • SPZOZ Centralny Szpital Kliniczny UM w Lodzi
  • Centrum Diagnostyczno - Terapeutyczne "MEDICUS" Sp.z o.o.
  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
  • Neurologiczny NZOZ Centrum Leczenia SM
  • NZOZ "NEURO-KARD", "Ilkowski i Partnerzy" Sp. Partn. Lek.
  • Centrum Medyczne Medyk
  • Neuro-Care Gabriela Klodowska
  • NZOZ "SENIOR" Poradnia Psychogeriatryczna
  • Osrodek Badan Klinicznych EUROMEDIS
  • mMED Maciej Czarnecki
  • Hospital General Universitario de Elche
  • ALTHAIA Hospital Sant Joan de Deu
  • Hospital Universitario Reina Sofía
  • Clinica Universidad de Navarra
  • Hospital del Mar
  • Hospital Universitari Quiron Dexeus
  • Hospital Universitari de Bellvitge
  • Hospital Universitari Arnau de Vilanova
  • Hospital Universitario Virgen Macarena
  • Skånes Universitetssjukhus, Malmö
  • Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus
  • Karolinska Universitetssjukhuset, Huddinge
  • Akademiska Sjukhuset
  • Universitären Psychiatrischen Kliniken Basel (UPK)
  • Medizinisches Zentrum MZB Biel
  • Hôpitaux Universitaires de Genève - HUG
  • Centre Hospitalier Universitaire Vaudois
  • Ospedale Civico
  • Institut fuer Regenerative Medizin (IREM) der Universitaet Zuerich, Zentrum fuer Praevention und Demenztherapie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low Dose

High Dose

Arm Description

Monthly intravenous (IV) infusions

Monthly intravenous (IV) infusions

Outcomes

Primary Outcome Measures

Change From Baseline in Clinical Dementia Rating Scale - 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) 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
NCT02484547
Brief Title
221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease
Acronym
EMERGE
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
September 15, 2015 (Actual)
Primary Completion Date
August 5, 2019 (Actual)
Study Completion Date
August 5, 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
Aducanumab, BIIB037

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1643 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose
Arm Type
Experimental
Arm Description
Monthly intravenous (IV) infusions
Arm Title
High Dose
Arm Type
Experimental
Arm Description
Monthly intravenous (IV) infusions
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 Scale - 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) 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
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Banner Alzheimer's Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Xenoscience Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Banner Sun Health Research Institute
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Institute for Memory Impairments
City
Irvine
State/Province
California
ZIP/Postal Code
92607
Country
United States
Facility Name
Renewal Behavioral Health
City
Long Beach
State/Province
California
ZIP/Postal Code
85013
Country
United States
Facility Name
USC Keck School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Excell Research, Inc.
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Pacific Neuroscience Medical Group
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Anderson Clinical Research
City
Redlands
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Pacific Research Network
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
University of California San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
Syrentis Clinical Research
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
St Joseph Heritage Healthcare
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University Of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
IMMUNOe International Research Centers
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80233
Country
United States
Facility Name
Associated Neurologists of Southern Connecticut, PC
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
Yale University School Of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Research Center for Clinical Studies, Inc.
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06851
Country
United States
Facility Name
JEM Research Institute
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Bradenton Research Center, Inc.
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Meridien Research
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
Facility Name
Quantum Laboratories Inc.
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Infinity Clinical Research, LLC
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Axiom Clinical Research of Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Emory University Cognitive Neurology Clinic & ADRC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Medical Research Health and Education Foundation, Inc
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909
Country
United States
Facility Name
NeuroStudies.net, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Josephson, Wallack, Munshower Neurology, PC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Facility Name
Boston Center for Memory
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
05201
Country
United States
Facility Name
Hattiesburg Clinic, PA
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Cleveland Clinic Lou Ruvo Center for Brain Health
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
ActivMed Practices & Research
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
AdvanceMed Research
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Empire Neurology, PC
City
Latham
State/Province
New York
ZIP/Postal Code
12110
Country
United States
Facility Name
Weill Cornell Medical College-New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
PMG Research of Winston-Salem, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Ohio State University Medical Center
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43017
Country
United States
Facility Name
Lehigh Center for Clinical Research, LLC
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Penn Memory Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Roper St. Francis Healthcare
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406-6076
Country
United States
Facility Name
Senior Adult Specialty Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
The Methodist Hospital Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Clinical Trial Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
University of Utah Health Sciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Clinical Neuroscience Research Association, Inc
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Northwest Neurological, PLLC
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
A.Z. Klina
City
Brasschaat
Country
Belgium
Facility Name
AZ Sint-Jan Brugge
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Universitair Ziekenhuis Brussel
City
Bruxelles
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Centre Neurologique & de Réadaptation Fonctionnelle
City
Fraiture
ZIP/Postal Code
4557
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ Groeninge - Campus Kennedylaan
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Health Research.
City
Kamloops
State/Province
British Columbia
Country
Canada
Facility Name
Health Research
City
West Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
True North Clinical Research - Halifax Inc.
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3S 1M7
Country
Canada
Facility Name
True North Clinical Research Kentville, Inc
City
Kentville
State/Province
Nova Scotia
ZIP/Postal Code
B4N 4K9
Country
Canada
Facility Name
JBN Medical Diagnostic Services Inc.
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7M 4Y1
Country
Canada
Facility Name
St. Joseph's HC- Parkwood Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 5J1
Country
Canada
Facility Name
Bruyere Continuing Care
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1N 5C8
Country
Canada
Facility Name
Kawartha Regional Memory Clinic
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9H 2P4
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Recherches Neuro-Hippocampe Inc.
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8T 8J1
Country
Canada
Facility Name
Recherche Sepmus, Inc.
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
DIEX Recherche Sherbrooke Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada
Facility Name
Douglas Hospital Research Centre
City
Verdun
State/Province
Quebec
ZIP/Postal Code
H4H 1R3
Country
Canada
Facility Name
Terveystalo Kamppi
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Facility Name
Itä-Suomen yliopisto, Aivotutkimusyksikkö
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
CRST, Clinical Research Services Turku
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Hôpital de la Timone
City
Marseille
State/Province
Bouches-du-Rhône
ZIP/Postal Code
13385
Country
France
Facility Name
CHU de Toulouse - Hôpital Purpan
City
Toulouse cedex 9
State/Province
Haute Garonne
ZIP/Postal Code
31059
Country
France
Facility Name
Centre de Recherche Clinique du Gérontopôle - Cité de la Santé
City
Toulouse
State/Province
Haute Garonne
ZIP/Postal Code
31052
Country
France
Facility Name
Hôpital Gui de Chauliac
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Rennes - Hopital Pontchaillou
City
Rennes cedex 09
State/Province
Ille Et Vilaine
ZIP/Postal Code
35033
Country
France
Facility Name
CHU Nantes - Hopital Nord Laënnec
City
Nantes cedex 1
State/Province
Loire Atlantique
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Roger Salengro - CHU Lille
City
Lille Cedex
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital des Charpennes
City
Villeurbanne
State/Province
Rhone
ZIP/Postal Code
69100
Country
France
Facility Name
Hôpital Fernand Widal
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Bezirkskrankenhaus Guenzburg
City
Gunzburg
State/Province
Baden Wuerttemberg
ZIP/Postal Code
89312
Country
Germany
Facility Name
ISPG - Institut fuer Studien zur Psychischen Gesundheit
City
Mannheim
State/Province
Baden Wuerttemberg
ZIP/Postal Code
68165
Country
Germany
Facility Name
Nervenfachaerztlichen Gemeinschaftspraxis Ulm
City
Ulm
State/Province
Baden Wuerttemberg
ZIP/Postal Code
89078
Country
Germany
Facility Name
Universitaetsklinikum Ulm
City
Ulm
State/Province
Baden Wuerttemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
Klinik Hohe Warte Bayreuth
City
Bayreuth
State/Province
Bayern
ZIP/Postal Code
95445
Country
Germany
Facility Name
Institut fuer Schlaganfall- und Demenzforschung (ISD)
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
Facility Name
Klinikum rechts der Isar der TU Muenchen
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
Neuropraxis Muenchen Sued
City
Unterhaching
State/Province
Bayern
ZIP/Postal Code
82008
Country
Germany
Facility Name
Neuro Centrum Odenwald
City
Erbach
State/Province
Hessen
ZIP/Postal Code
64711
Country
Germany
Facility Name
Universitaetsklinikum Duesseldorf AoeR
City
Duesseldorf
State/Province
Nordrhein Westfalen
ZIP/Postal Code
40629
Country
Germany
Facility Name
Universitaetsklinikum Muenster
City
Muenster
State/Province
Nordrhein Westfalen
ZIP/Postal Code
48149
Country
Germany
Facility Name
Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung
City
Siegen
State/Province
Nordrhein Westfalen
ZIP/Postal Code
57076
Country
Germany
Facility Name
Schwerpunktpraxis fuer Neurologie, Psychiatrie und Klinische Studien
City
Bielefeld
State/Province
North Rhine-Westphalia
ZIP/Postal Code
33647
Country
Germany
Facility Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
City
Mainz
State/Province
Rheinland Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Klinikum Chemnitz gGmbH
City
Chemnitz
State/Province
Sachsen
ZIP/Postal Code
09131
Country
Germany
Facility Name
Kopfzentrum Leipzig
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04275
Country
Germany
Facility Name
Klinikum Altenburger Land GmbH
City
Altenburg
State/Province
Thueringen
ZIP/Postal Code
04600
Country
Germany
Facility Name
emovis GmbH
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
Neurologie im Tempelhofer Hafen
City
Berlin
ZIP/Postal Code
12099
Country
Germany
Facility Name
Ospedale degli Infermi
City
Ponderano
State/Province
Biella
ZIP/Postal Code
13875
Country
Italy
Facility Name
Azienda Ospedaliera Card. G. Panico
City
Tricase
State/Province
Lecce
ZIP/Postal Code
73039
Country
Italy
Facility Name
ASST di Monza
City
Monza
State/Province
Milano
ZIP/Postal Code
20052
Country
Italy
Facility Name
Fondazione IRCCS Istituto Neurologico Carlo Besta
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
City
Palermo
ZIP/Postal Code
90100
Country
Italy
Facility Name
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
City
Perugia
ZIP/Postal Code
06156
Country
Italy
Facility Name
Fondazione Santa Lucia IRCCS
City
Roma
ZIP/Postal Code
00179
Country
Italy
Facility Name
Umberto I Pol. di Roma-Università di Roma La Sapienza
City
Roma
ZIP/Postal Code
00185
Country
Italy
Facility Name
Research Site
City
Obu-shi
State/Province
Aichi-Ken
ZIP/Postal Code
474-8511
Country
Japan
Facility Name
Research Site
City
Toon-shi
State/Province
Ehime-Ken
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
Research Site
City
Fukuoka-shi
State/Province
Fukuoka-Ken
ZIP/Postal Code
814-0180
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
Otake-shi
State/Province
Hiroshima-Ken
ZIP/Postal Code
739-0696
Country
Japan
Facility Name
Research Site
City
Amagasaki-shi
State/Province
Hyogo-Ken
ZIP/Postal Code
660-8511
Country
Japan
Facility Name
Research site
City
Himeji-shi
State/Province
Hyogo-Ken
ZIP/Postal Code
670-0981
Country
Japan
Facility Name
Research Site
City
Himeji-shi
State/Province
Hyogo-Ken
ZIP/Postal Code
672-8043
Country
Japan
Facility Name
Research Site
City
Kobe-shi
State/Province
Hyogo-Ken
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Research Site
City
Kita-gun
State/Province
Kagawa-Ken
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Research Site
City
Kyoto-shi
State/Province
Kyoto-Fu
ZIP/Postal Code
607-8113
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
Tsu-shi
State/Province
Mie-Ken
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
Research Site
City
Nishisonogi
State/Province
Nagasaki-Ken
ZIP/Postal Code
851-2103
Country
Japan
Facility Name
Research Site
City
Yufu-shi
State/Province
Oita-Ken
ZIP/Postal Code
879-5593
Country
Japan
Facility Name
Research Site
City
Kurashiki-shi
State/Province
Okayama-Ken
ZIP/Postal Code
710-0813
Country
Japan
Facility Name
Research Site
City
Okayama-shi
State/Province
Okayama-Ken
ZIP/Postal Code
703-8265
Country
Japan
Facility Name
Research Site
City
Tsukuba-gun
State/Province
Okayama-Ken
ZIP/Postal Code
701-0304
Country
Japan
Facility Name
Research Site
City
Kishiwada-shi
State/Province
Osaka-Fu
ZIP/Postal Code
596-8522
Country
Japan
Facility Name
Research Site
City
Osaka-shi
State/Province
Osaka-Fu
ZIP/Postal Code
530-0001
Country
Japan
Facility Name
Research Site
City
Osaka-shi
State/Province
Osaka-Fu
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Research Site
City
Osaka-shi
State/Province
Osaka-Fu
ZIP/Postal Code
553-0003
Country
Japan
Facility Name
Research Site
City
Sennan-shi
State/Province
Osaka-Fu
ZIP/Postal Code
590-0503
Country
Japan
Facility Name
Research Site
City
Suita-shi
State/Province
Osaka-Fu
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Research Site
City
Iwata-shi
State/Province
Shizuoka-Ken
ZIP/Postal Code
438-0043
Country
Japan
Facility Name
Research Site
City
Shizuoka-shi
State/Province
Shizuoka-Ken
ZIP/Postal Code
420-8688
Country
Japan
Facility Name
Research Site
City
Shizuoka-shi
State/Province
Shizuoka-Ken
ZIP/Postal Code
424-8636
Country
Japan
Facility Name
Alzheimer Research Center
City
Amsterdam
ZIP/Postal Code
1081 GM
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Podlaskie Centrum Psychogeriatrii
City
Bialystok
ZIP/Postal Code
15-732
Country
Poland
Facility Name
PALLMED Sp. z o.o.
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
Country
Poland
Facility Name
Novo-Med Zielinski i wspolnicy Sp. j.
City
Katowice
ZIP/Postal Code
40-650
Country
Poland
Facility Name
SPZOZ Centralny Szpital Kliniczny UM w Lodzi
City
Lodz
ZIP/Postal Code
92-216
Country
Poland
Facility Name
Centrum Diagnostyczno - Terapeutyczne "MEDICUS" Sp.z o.o.
City
Lubin
ZIP/Postal Code
59-300
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
City
Lublin
ZIP/Postal Code
20-950
Country
Poland
Facility Name
Neurologiczny NZOZ Centrum Leczenia SM
City
Plewiska
ZIP/Postal Code
62-064
Country
Poland
Facility Name
NZOZ "NEURO-KARD", "Ilkowski i Partnerzy" Sp. Partn. Lek.
City
Poznan
ZIP/Postal Code
61-853
Country
Poland
Facility Name
Centrum Medyczne Medyk
City
Rzeszow
ZIP/Postal Code
35-055
Country
Poland
Facility Name
Neuro-Care Gabriela Klodowska
City
Slaskie
ZIP/Postal Code
41-100
Country
Poland
Facility Name
NZOZ "SENIOR" Poradnia Psychogeriatryczna
City
Sopot
ZIP/Postal Code
81-855
Country
Poland
Facility Name
Osrodek Badan Klinicznych EUROMEDIS
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
mMED Maciej Czarnecki
City
Warszawa
ZIP/Postal Code
01-697
Country
Poland
Facility Name
Hospital General Universitario de Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
3203
Country
Spain
Facility Name
ALTHAIA Hospital Sant Joan de Deu
City
Manresa
State/Province
Barcelona
ZIP/Postal Code
08243
Country
Spain
Facility Name
Hospital Universitario Reina Sofía
City
Cordoba
State/Province
Córdoba
ZIP/Postal Code
14011
Country
Spain
Facility Name
Clinica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitari Quiron Dexeus
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Universitari de Bellvitge
City
Barcelona
ZIP/Postal Code
8907
Country
Spain
Facility Name
Hospital Universitari Arnau de Vilanova
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Skånes Universitetssjukhus, Malmö
City
Malmö
ZIP/Postal Code
20502
Country
Sweden
Facility Name
Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus
City
Mölndal
ZIP/Postal Code
43141
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset, Huddinge
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Name
Akademiska Sjukhuset
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Universitären Psychiatrischen Kliniken Basel (UPK)
City
Basel
ZIP/Postal Code
4025
Country
Switzerland
Facility Name
Medizinisches Zentrum MZB Biel
City
Biel/Bienne
ZIP/Postal Code
2502
Country
Switzerland
Facility Name
Hôpitaux Universitaires de Genève - HUG
City
Geneve 14
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Facility Name
Ospedale Civico
City
Lugano
ZIP/Postal Code
6903
Country
Switzerland
Facility Name
Institut fuer Regenerative Medizin (IREM) der Universitaet Zuerich, Zentrum fuer Praevention und Demenztherapie
City
Schlieren
ZIP/Postal Code
8952
Country
Switzerland

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

221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease

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