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

Phase 3TerminatedNCT04241068

Biogen1,696 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

1,696

Conditions

Alzheimer's Disease

Interventions

AducanumabDRUG

Administered as specified in the treatment arm.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 90 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: Core Treatment Period: * Participant was participating in an aducanumab clinical study at the time of the announcement of early termination (feeder studies). * Has one care partner who, in the Investigator's opinion, has adequate contact with the participant as to be able to provide accurate information about the participant's cognitive and functional abilities. LTE Treatment Period: * Participant must have completed the Core study period (Week 102) and adequately tolerated 10 mg/kg of aducanumab during the Core study period in the opinion of the Investigator. * Has one informant/care partner who, in the Investigator's opinion, has frequent and sufficient contact with the participant as to be able to provide accurate information about the participant's cognitive and functional abilities. Key Exclusion Criteria: Core Treatment Period: * Any medical or neurological condition (other than Alzheimer's Disease) that might be a contributing cause of the participant's cognitive impairment. * Stroke or any unexplained loss of consciousness within 1 year prior to Screening. * 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. * A seizure event that occurred after the last visit of the feeder study and before Screening for this study. * Evidence of impaired liver function as shown by an abnormal liver function profile at Screening. * History of or known seropositivity for HIV. * Clinically significant systemic illness or serious infection within 30 days prior to or during Screening. * Contraindications to having a brain magnetic resonance imaging (MRI). LTE Treatment Period: * Any medical or psychiatric contraindication or clinically significant abnormality that, in the opinion of the Investigator, will substantially increase the risk associated with the participant's enrollment in and completion of the study. Note- Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (297)

Outcomes

Primary Outcomes

Core Treatment Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs

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.

Time frame: From the first dose of study drug to end of follow-up (up to Week 118)

Core Treatment Period: Number of Participants With AEs Leading to Treatment Discontinuation (TD) and Study Withdrawal (SW)

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.

Time frame: From the first dose of study drug to end of follow-up (up to Week 118)

Core Treatment Period: Number of Participants With Amyloid-Related Imaging Abnormality-Edema (ARIA-E)

Number of participants diagnosed with ARIA edema are reported.

Time frame: Up to Week 118

Core Treatment Period: Number of Participants With Amyloid-Related Imaging Abnormality- Hemorrhage or Superficial Siderosis (ARIA-H)

Data from ClinicalTrials.gov

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Banner Alzheimer's Institute

Phoenix, Arizona, United States

Dignity Health

Phoenix, Arizona, United States

Banner Sun Health Research Institute

Sun City, Arizona, United States

Center for Neurosciences

Tucson, Arizona, United States

Neurology Center of North Orange County

Fullerton, California, United States

UCI MIND

Irvine, California, United States

University of California San Diego Medical Center

La Jolla, California, United States

Senior Clinical Trials, Inc.

Laguna Hills, California, United States

USC Keck School of Medicine

Los Angeles, California, United States

...and 287 more locations