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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04241068
Recruitment Status : Active, not recruiting
First Posted : January 27, 2020
Last Update Posted : May 13, 2022
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Aducanumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1696 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 13, 2020
Estimated Primary Completion Date : October 11, 2023
Estimated Study Completion Date : February 24, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Aducanumab

Arm Intervention/treatment
Experimental: Aducanumab
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.
Drug: Aducanumab
Administered as specified in the treatment arm.
Other Name: BIIB037




Primary Outcome Measures :
  1. Core Treatment Period: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Week 100 ]
    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.

  2. Core Treatment Period: Number of Participants with AEs Leading to Treatment Discontinuation or Study Withdrawal [ Time Frame: Up to Week 100 ]
    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.

  3. Core Treatment Period: Number of Participants with Amyloid-related Imaging Abnormality-Edema (ARIA-E) [ Time Frame: Up to Week 100 ]
    Magnetic resonance imaging (MRI) readings will be used to assess ARIA-E severity as mild, moderate and severe.

  4. Core Treatment Period: Number of Participants with Amyloid-related Imaging Abnormality- Hemorrhage or Superficial Siderosis (ARIA-H) [ Time Frame: Up to Week 100 ]
    MRI readings will be used to assess severity of ARIA-H microhemorrhages and superficial siderosis.

  5. Core Treatment Period: Number of Participants With Antidrug Antibodies (ADAs) in Serum [ Time Frame: Up to Week 100 ]
    Presence of serum ADAs will be determined using a validated assay.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241068


Locations
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Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT04241068    
Other Study ID Numbers: 221AD304
2019-004368-22 ( EudraCT Number )
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: May 13, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders