Aducanumab

Generic Name
Aducanumab
Brand Names
Aduhelm
Drug Type
Biotech
Chemical Formula
-
CAS Number
1384260-65-4
Unique Ingredient Identifier
105J35OE21
Background

Aducanumab, or BIIB037, is a monoclonal IgG1 antibody that targets extracellular amyloid-β plaques in the brain; similar to gantenerumab, bapineuzumab and solanezumab. Aducanumab is a recombinant antibody derived from patients with slow or absent cognitive decline, and phase 1b clinical trial data have shown patients treated with aducanumab show a reduction ...

Indication

Aducanumab is indicated for the treatment of Alzheimer’s disease. Treatment should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were ...

Associated Conditions
Alzheimer's Disease (AD)
Associated Therapies
-

Safety and Feasibility of Exablate Blood-Brain Barrier Disruption for Mild Cognitive Impairment or Mild Alzheimer's Disease Undergoing Standard of Care Monoclonal Antibody (mAb) Therapy

First Posted Date
2022-07-21
Last Posted Date
2024-02-20
Lead Sponsor
Ali Rezai
Target Recruit Count
15
Registration Number
NCT05469009
Locations
🇺🇸

West Virginia University Rockefeller Neuroscience Institute, Morgantown, West Virginia, United States

A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer's Disease

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2022-04-04
Last Posted Date
2024-07-03
Lead Sponsor
Biogen
Target Recruit Count
1512
Registration Number
NCT05310071
Locations
🇺🇸

University of Maryland Medical Center, Baltimore, Maryland, United States

🇺🇸

Mary S. Easton Center for Alzheimer's Disease Research, UCLA, Los Angeles, California, United States

🇺🇸

UT Southwestern Medical Center, Dallas, Texas, United States

and more 311 locations

A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)

First Posted Date
2021-11-05
Last Posted Date
2024-11-28
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
148
Registration Number
NCT05108922
Locations
🇺🇸

Neurology Center of North Orange County, Fullerton, California, United States

🇺🇸

Josephson Wallack Munshower Neurology, PC, Indianapolis, Indiana, United States

🇺🇸

Conquest Research, Winter Park, Florida, United States

and more 27 locations

A Study to Assess Absolute Bioavailability of Aducanumab in Healthy Volunteers

Phase 1
Completed
Conditions
Interventions
First Posted Date
2021-06-11
Last Posted Date
2023-04-13
Lead Sponsor
Biogen
Target Recruit Count
30
Registration Number
NCT04924140
Locations
🇺🇸

Anaheim Clinical Trials, LLC, Anaheim, California, United States

🇺🇸

Qps-Mra, Llc, South Miami, Florida, United States

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 3
Terminated
Conditions
Interventions
First Posted Date
2020-01-27
Last Posted Date
2024-08-23
Lead Sponsor
Biogen
Target Recruit Count
1696
Registration Number
NCT04241068
Locations
🇨🇦

Montreal Neurological Institute Clinical Research Unit, Montréal, Quebec, Canada

🇫🇷

CHU Lille - Hopital Roger Salengro, Lille Cedex, Nord, France

🇫🇷

Hôpital Lariboisière, Paris cedex 10, Paris, France

and more 256 locations

A Study of Aducanumab in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease Dementia to Evaluate the Safety of Continued Dosing in Participants With Asymptomatic Amyloid-Related Imaging Abnormalities

First Posted Date
2018-08-21
Last Posted Date
2021-09-16
Lead Sponsor
Biogen
Target Recruit Count
52
Registration Number
NCT03639987
Locations
🇺🇸

Neurology Center of North Orange County, Fullerton, California, United States

🇺🇸

Pacific Research Network, Inc, San Diego, California, United States

🇺🇸

Neuropsychiatric Research Center of Southwest Florida, Fort Myers, Florida, United States

and more 18 locations

Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Aducanumab in Healthy Participants

Phase 1
Completed
Conditions
Interventions
First Posted Date
2016-05-26
Last Posted Date
2017-01-13
Lead Sponsor
Biogen
Target Recruit Count
28
Registration Number
NCT02782975
Locations
🇺🇸

Research Site, Dallas, Texas, United States

Single and Multiple Ascending Dose Study of Aducanumab (BIIB037) in Japanese Participants With Alzheimer's Disease

Phase 1
Completed
Conditions
Interventions
First Posted Date
2015-05-05
Last Posted Date
2020-08-21
Lead Sponsor
Biogen
Target Recruit Count
21
Registration Number
NCT02434718
Locations
🇯🇵

Research Site, Kyoto, Japan

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