Aducanumab for Alzheimer's Disease

Recruiting at292 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Biogen

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing the safety of aducanumab, a drug that may help clear harmful proteins from the brain, in people who have already taken it. Aducanumab aims to reduce the accumulation of these proteins and slow cognitive impairment in Alzheimer's disease.

Research Team

Medical Director

Principal Investigator

Biogen

Eligibility Criteria

This trial is for individuals with Alzheimer's who were part of previous aducanumab studies. They must have finished the initial study period, tolerated a specific dose well, and have a care partner to report on their cognitive abilities. People with recent serious health issues or certain medical conditions are excluded.

Inclusion Criteria

It seems like the criterion you provided is incomplete. Could you please provide more details or context so that I can assist you better?

You were taking part in a study for aducanumab when it was stopped early.

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.

Exclusion Criteria

I have tested positive for HIV.

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.

I had a seizure between my last doctor's visit and now.

Treatment Details

Interventions

• Aducanumab (Monoclonal Antibodies)

Trial Overview The trial tests the safety and tolerability of aducanumab in people with Alzheimer's over 100 weeks after they've had a break from earlier related trials. It includes those who previously received aducanumab as well as those who initially got a placebo.

Participant Groups

Group I: Aducanumab Experimental Treatment 1 Intervention

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.

Aducanumab is already approved in Canada, Japan for the following indications:

Approved in Canada as Aducanumab for:

• Not approved due to insufficient evidence of efficacy

Approved in Japan as Aducanumab for:

• Not approved due to insufficient evidence of efficacy

Who Is Running the Clinical Trial?

Biogen

Lead Sponsor

Trials

655

Recruited

468,000+

Daniel Quirk

Biogen

Chief Medical Officer

MD

Christopher A. Viehbacher

Biogen

Chief Executive Officer since 2022

Graduated from Queen's University, Kingston, Ontario, Canada