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NCT05097131 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Biogen.

Terminated
Registry status
29
Enrollment target

NCT05097131: Clinical Trial study, sponsored by Biogen.

NCT05097131 is a clinical trial that was terminated before completion, run by Biogen. The registered enrollment target is 29 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05097131 was terminated before completion, sponsored by Biogen.

TERMINATED
Registry status
29 participants
Enrollment target

Study Summary

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.

Primary Outcome

QDRS-IV /PV is rapid dementia staging tool. It is a 10-item questionnaire completed by an informant and a participant. The 10 domains covered are memory and recall, orientation, decision-making and problem-solving abilities, activities outside the home, function at home and hobbies, toileting and personal hygiene, behavior and personality changes, language and communication abilities, mood, and attention and concentration. Each domain is rated on five-point scale with increasing severity of symp

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2021-11-18
Est. Completion 2022-05-20
Biogen

334 total trials

Why NCT05097131 stopped before completion

NCT05097131 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 29 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT05097131 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05097131 about?

NCT05097131 is a clinical study titled "An Observational Study of Aducanumab-avwa in Participants With Alzheimer's Disease in the US". 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...

What is the current status of trial NCT05097131?

This trial is currently terminated. The enrollment target is 29 participants. The study started on 2021-11-18. Estimated completion is 2022-05-20.

Who is sponsoring clinical trial NCT05097131?

This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT05097131, the US trial registry maintained by the National Library of Medicine. NCT05097131 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.