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Ultrasound FAQ

What is a clinical trial?

Clinical trials are research investigations in which people volunteer to test new treatments, interventions, or tests as a means to prevent, detect, treat or manage a disease or medical condition. The first phase of trial for medical devices is a pilot or feasibility trial which is designed to assess safety primarily. If the safety trial is successful, further phases investigate whether the treatment works. 

When will the ultrasound clinical trial commence?

The first trial will be a small-scale study to assess the safety of the ultrasound technology for human use. The exact commencement date for the trial is yet to be determined.

What is the overarching aim of the safety trial?

The initial trial aims to confirm that scanning ultrasound is safe for human use. If the technology is deemed safe, Phase II will be designed to determine whether ultrasound is an effective treatment for Alzheimer’s disease.

Who is managing the trial?

The initial safety trial is not yet open for volunteer recruitment and will independently monitored externally by a specialist clinical research organisation, working with Brisbane neurologists.

The Queensland Brain Institute and The University of Queensland will have no role in trial recruitment. Participation in the trial will depend on potential candidates passing rigorous inclusion and exclusion criteria.

More details will be available when recruitment for the trial begins, the exact date for which has yet to be determined. 

Who will be considered for the trial?

To be considered for the human safety trial participants must be:

  • Aged between 50-85 years
  • Have a confirmed diagnosis of Alzheimer’s disease by a doctor
  • Able to have MRI scans
  • Be in reasonable general health
  • Prepared to have head shaved
  • Preferably still living at home
  • Must be able to comply with the study assessment schedule

Is QBI keeping a list of people interested in participating in the clinical trial?

No, we are unable to keep a list of interested parties as recruitment will be managed by the external Clinical Research Organisation and can only commence once ethics approval has been received. Please check this page for updates. Once recruitment has commenced, we will provide a link through to the recruitment website.

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