An Observational Study of Aducanumab-avwa in Participants With Alzheimer's Disease in the US

NCT ID: NCT05097131

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-18

Study Completion Date

2022-05-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a prospective, single-arm, multicenter, non-interventional study of aducanumab-avwa as prescribed in the post-marketing setting in the US. Investigators will be prescribing aducanumab-avwa and participants will be treated according to the standard of care (SoC). Participants will be followed up to 5 years after enrollment and data will be collected at routine visits every 6 to 12 months.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimers Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

All Participants

Participants who have been prescribed with aducanumab-avwa in the post-marketing setting according to standard care of practice will be enrolled.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participant has a diagnosis of Alzheimer's Disease (AD) and is prescribed aducanumab-avwa by their treating physician.
* Participant's treating physician has made the decision to initiate aducanumab-avwa prior to participant inclusion and independently of the purpose of the study.

Exclusion Criteria

* Participant concurrently participates in any interventional clinical study.
* Participant has ever been treated with aducanumab-avwa at a dose of 3 milligrams per kilogram (mg/kg) or greater prior to signing ICF.
* Participant has ever been treated with aducanumab-avwa and discontinued treatment prior to signing ICF.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Chula Vista, California, United States

Site Status

Mehdi Meratee MD

Valencia, California, United States

Site Status

Research Site

Boca Raton, Florida, United States

Site Status

Research Site

Bradenton, Florida, United States

Site Status

New Life Medical Research Center, Inc

Hialeah, Florida, United States

Site Status

Miami Jewish Health System, Inc

Miami, Florida, United States

Site Status

Imic, Inc.

Palmetto Bay, Florida, United States

Site Status

Neurostudies, Inc

Port Charlotte, Florida, United States

Site Status

Vero Beach Neurology and Research Institute

Vero Beach, Florida, United States

Site Status

Northwest Neurology

Chicago, Illinois, United States

Site Status

Research Site

Ozark, Missouri, United States

Site Status

Las Vegas Medical Research

Las Vegas, Nevada, United States

Site Status

South Shore Neurologic Associates, P.A.

Patchogue, New York, United States

Site Status

Carolina Clinical Research & Consulting, LLC

Asheboro, North Carolina, United States

Site Status

Research Site

Matthews, North Carolina, United States

Site Status

Research Site

Canton, Ohio, United States

Site Status

Dayton Center for Neurological Associates

Centerville, Ohio, United States

Site Status

Center for Cognitive Health

Portland, Oregon, United States

Site Status

Abington Neurological Associates

Abington, Pennsylvania, United States

Site Status

Coastal Neurology, PA

Port Royal, South Carolina, United States

Site Status

Genesis Neuroscience Clinic

Knoxville, Tennessee, United States

Site Status

The Memory Clinic

Bennington, Vermont, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

US-ALZ-11855

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.