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

Biogen

Status: Terminated

Conditions: Alzheimers Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT05097131

US-ALZ-11855

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Key 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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Trial design

29 participants in 1 patient group

All Participants

Description:

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