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Trial record 6 of 8 for:    Aducanumab

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 : Enrolling by invitation
First Posted : January 27, 2020
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief Summary:
The primary objective is to evaluate the long-term safety and tolerability of aducanumab 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)
Estimated Enrollment : 2400 participants
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 : September 1, 2023
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aducanumab
Participants will be administered 10mg/kg aducanumab by intravenous (IV) infusions every four weeks for a total duration of 100 weeks.
Drug: Aducanumab
Administered as specified in the treatment arm.
Other Name: BIIB037




Primary Outcome Measures :
  1. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Week 118 ]
    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. Number of Participants with AEs Leading to Treatment Discontinuation or Study Withdrawal [ Time Frame: Up to Week 118 ]
    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. Number of Participants with Amyloid-related Imaging Abnormality-Edema (ARIA-E) [ Time Frame: Up to Week 102 ]
    Magnetic resonance imaging (MRI) readings will be used to assess ARIA-E severity as mild, moderate and severe.

  4. Number of Participants with Amyloid-related Imaging Abnormality- Hemorrhage or Superficial Siderosis (ARIA-H) [ Time Frame: Up to Week 102 ]
    MRI readings will be used to assess severity of ARIA-H microhemorrhages and superficial siderosis.

  5. Number of Participants With Anti-aducanumab Antibodies in Serum [ Time Frame: Up to Week 102 ]
    Presence of serum anti-aducanumab antibodies will be determined using a validated assay.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant was participating in an aducanumab clinical study at the time of the announcement of early termination (Studies 221AD301, 221AD302, 221AD103 and 221AD205, referred to as "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.

Exclusion Criteria: -

  • Any medical or neurological condition (other than Alzheimer's Disease) that might be a contributing cause of the subject'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 stopping 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).

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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United States, Florida
Brain Matters Research
Delray Beach, Florida, United States, 334405
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States, 33912
United States, New Jersey
Advanced Memory Research Inst. of NJ, PC
Toms River, New Jersey, United States, 08755
United States, Vermont
The Memory Clinic
Bennington, Vermont, United States, 05201
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: March 23, 2020
Last Verified: March 2020
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/

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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