biogen/studies/attachments/NCT04241068-Synopsis.pdf

NCT04241068-Synopsis

biogen/studies/attachments/NCT04241068-LLS_Chinese_Traditional_Taiwan.pdf

NCT04241068-LLS Chinese Traditional (Taiwan)

biogen/studies/attachments/NCT04241068-LLS_Danish_Denmark.pdf

NCT04241068-LLS Danish (Denmark)

biogen/studies/attachments/NCT04241068-LLS_Dutch_Belgium.pdf

NCT04241068-LLS Dutch (Belgium)

biogen/studies/attachments/NCT04241068-LLS_Dutch_Netherlands.pdf

NCT04241068-LLS Dutch (Netherlands)

biogen/studies/attachments/NCT04241068-LLS.pdf

NCT04241068-LLS English

biogen/studies/attachments/NCT04241068-LLS_Finnish_Finland.pdf

NCT04241068-LLS Finnish (Finland)

biogen/studies/attachments/NCT04241068-LLS_French_Belgium.pdf

NCT04241068-LLS French (Belgium)

biogen/studies/attachments/NCT04241068-LLS_French_Canada.pdf

NCT04241068-LLS French (Canada)

biogen/studies/attachments/NCT04241068-LLS_French_France.pdf

NCT04241068-LLS French (France)

biogen/studies/attachments/NCT04241068-LLS_French_Switzerland.pdf

NCT04241068-LLS French (Switzerland)

biogen/studies/attachments/NCT04241068-LLS_German_Austria.pdf

NCT04241068-LLS German (Austria)

biogen/studies/attachments/NCT04241068-LLS_German_Germany.pdf

NCT04241068-LLS German (Germany)

biogen/studies/attachments/NCT04241068-LLS_German_Switzerland.pdf

NCT04241068-LLS German (Switzerland)

biogen/studies/attachments/NCT04241068-LLS_Italian_Italy.pdf

NCT04241068-LLS Italian (Italy)

biogen/studies/attachments/NCT04241068-LLS_Italian_Switzerland.pdf

NCT04241068-LLS Italian (Switzerland)

biogen/studies/attachments/NCT04241068-LLS_Japanese_Japan.pdf

NCT04241068-LLS Japanese (Japan)

biogen/studies/attachments/NCT04241068-LLS_Korean_Korea.pdf

NCT04241068-LLS Korean (Korea)

biogen/studies/attachments/NCT04241068-LLS_Polish_Poland.pdf

NCT04241068-LLS Polish (Poland

biogen/studies/attachments/NCT04241068-LLS_Portugues_Portugal.pdf

NCT04241068-LLS Portuguese (Portugal)

biogen/studies/attachments/NCT04241068-LLS_Spanish_Spain.pdf

NCT04241068-LLS Spanish (Spain)

biogen/studies/attachments/NCT04241068-LLS_Spanish_United_States.pdf

NCT04241068-LLS Spanish (United States)

biogen/studies/attachments/NCT04241068-LLS_Swedesh_Sweden.pdf

NCT04241068-LLS Swedish (Sweden)

The primary objective is to evaluate the safety and tolerability of aducanumab over 100 weeks of treatment after a wash-out period imposed by discontinuation of feeder studies in participants who had previously received aducanumab (i.e. previously treated participants) or who had previously received placebo (i.e. treatment-naïve participants).

A Study to Evaluate Safety and Tolerability of Aducanumab in Participants With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205

Alzheimer's Disease

Alzheimer's Disease and Dementia

BIIB037 (aducanumab)

Phase 3b Open-Label, Multicenter, Safety Study of BIIB037 (Aducanumab) in Subjects With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205

An AE is any untoward medical occurrence in a participant/clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal(investigational) product, whether or not related to medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, is a life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in significant disability/incapacity or congenital anomaly, is medically important event. TEAE or Serious TEAEs are defined as any AE that has an onset date and time that is on or after date and time of first dose of study treatment, or that has worsened after date and time of first dose of study treatment.

An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Number of participants diagnosed with ARIA edema are reported.

Number of participants diagnosed with ARIA hemmorrhage or superficial siderosis are reported.

The presence of serum ADAs was determined using a validated assay. A standard 3-tiered approach was used including screening assay, confirmatory assay, and titration assay. The number of participants with a positive response to ADAs are reported.

Participants will be administered aducanumab 10 milligrams per kilogram (mg/kg) by intravenous (IV) infusions every four weeks (Q4W) for a duration of 100 weeks during the Core Treatment Period. Eligible participants will continue to receive aducanumab 10 mg/kg IV infusion, Q4W, for 52 weeks during the Long-Term Extension (LTE) Treatment Period.

ADUHELM®

The primary objective is to evaluate the safety and tolerability of aducanumab over 100 weeks
      of treatment after a wash-out period imposed by discontinuation of feeder studies in
      participants who had previously received aducanumab (i.e. previously treated participants) or
      who had previously received placebo (i.e. treatment-naïve participants).

University of Alabama at Birmingham

Banner Alzheimer's Institute

Dignity Health

Banner Sun Health Research Institute

Center for Neurosciences

Neurology Center of North Orange County

UCI MIND

University of California San Diego Medical Center

Senior Clinical Trials, Inc.

USC Keck School of Medicine

Mary S. Easton Center for Alzheimer's Disease Research, UCLA

Pacific Neuroscience Medical Group

Stanford Hospital and Clinics

Anderson Clinical Research

Pacific Research Network, Inc

UCSF - Memory and Aging Center

Syrentis Clinical Research

California Neuroscience Research Medical Group Inc.

University of Colorado Denver

IMMUNOe International Research Centers

Yale University

Invicro

Yale University School Of Medicine

Research Center for Clinical Studies, Inc.

Georgetown University Clinical Research Unit (CRU)

JEM Research

Bradenton Research Center, Inc

Brain Matters Research

Neuropsychiatric Research Center of Southwest Florida

Infinity Clinical Research, LLC

Jacksonville Center for Clinical Research

Mayo Clinic in Florida

University of Miami

Miami Jewish Health System, Inc

Renstar Medical Research

Accelerated Enrollment Solutions (AES)

Clinical Neuroscience Solutions, Inc.

Palm Beach Neurological Center

Quantum Laboratories Inc.

Axiom Clinical Research of Florida

Stedman Clinical Trials, LLC

USF Health Byrd Institute

Meridien Research

Premiere Research Institute

Cleveland Clinic Florida - Weston

Emory University Cognitive Neurology Clinic & ADRC

Medical Research Health and Education Foundation, Inc

NeuroStudies.net, LLC

Alexian Brothers Medical Center - Neuroscience Research Institute

Advocate Lutheran General Hospital

Fort Wayne Neurological Center

Indiana University School of Medicine

Josephson, Wallack, Munshower Neurology, P.C.

University of Kansas Medical Center Research Institute, Inc.

Ascension Via Christi Research, a division of Ascension Via Christi Hospitals Wichita, Inc.

Baptist Health Lexington

McLean Hospital

Beth Israel Deaconess Medical Center

Brigham and Women's Hospital Department of Neurology

ActivMed Practices & Research, Inc.

Boston Center for Memory

Donald S. Marks, M.D., P.C.

Mayo Clinic

Hattiesburg Clinic, PA

Washington University

Cleveland Clinic Lou Ruvo Center for Brain Health

Las Vegas Medical Research

Advanced Memory Research Inst. of NJ, PC

Albany Medical College

Empire Neurology, PC

New York University Medical Center PRIME

Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)

Mount Sinai School of Medicine

University of Rochester

AMC Research, LLC

Raleigh Neurology Associates

Gastroenterology Associates of the Piedmont

Wake Forest Baptist Health

Cleveland Clinic Foundation

Ohio State University Wexner Medical Center

Lynn Health Science Institute

Lehigh Center for Clinical Research, LLC

The Clinical Trial Center, LLC

Penn Memory Center

University of Pittsburgh

Northeastern Pennsylvania Memory and Alzheimer's Center

Rhode Island Mood & Memory Research Institute

Rhode Island Hospital

Butler Hospital

Roper St. Francis Healthcare

Medical University of South Carolina (MUSC)

Neurology Clinic, PC

Senior Adult Specialty Research

UT Southwestern Medical Center

Baylor College of Medicine

Clinical Trial Network

University of Utah Health Sciences Center

The Memory Clinic

An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A SAE is any untoward medical occurrence that at any dose results in death, life-threatening event, requires inpatient hospitalization, significant disability/incapacity or congenital anomaly.

Magnetic resonance imaging (MRI) readings will be used to assess ARIA-E severity as mild, moderate and severe.

MRI readings will be used to assess severity of ARIA-H microhemorrhages and superficial siderosis.