QBI SUS - Novel Ultrasound Therapy to Improve Memory Function in Alzheimer’s Disease

Alzheimer's Disease

Currently available treatments for Alzheimer’s Disease address the symptoms, but do not stop the disease from progressing.  A potential new treatment is being trialled using a device that delivers a specific form of ultrasound energy to regions of the brain that are affected by Alzheimer’s disease.  This intervention produces an effect known as “neuromodulation”, which is an alteration of nerve activity and overall brain function. The application of ultrasound neuromodulation has been shown to enhance the communication between brain cells and to improve memory in aged animals. 

The present study evaluates the safety and tolerability of the novel treatment in a small number of participants with Alzheimer’s Disease.  The effects on memory and thinking abilities will also be tested.  If successful, a subsequent trial will evaluate the experimental treatment in large patient cohorts to provide statistically robust evidence of safety and efficacy. 

Category
Trial Status
Recruiting
Trial Phase
Medical Device Pilot Study
Universal Trial Number (UTN)
U1111-1277-9917
Trial contact details
Contact Person
Caitlin McElligott
What you need to know

Who can take part?

  • People who have been diagnosed with Alzheimer’s Disease
  • Aged 50-85
  • Otherwise healthy for a person of their age
  • If taking medications for dementia, must be on stable dosage for the past 2 months
  • Participants must have a caregiver who can attend clinic visits
  • Must be fully vaccinated for COVID-19
  • Must not be taking blood thinners such as warfarin (aspirin is permitted)

What is involved for you?

Participants in the study will have four ultrasound neuromodulation treatments, scheduled two weeks apart.  Participants will have to have their heads shaved to permit accurate placement of the ultrasound device.  Wigs will be provided to participants who want them.  Participants and their caregivers will also undertake the following assessments on the study:

  • Medical history
  • Physical exam and vital signs
  • Caregiver interview
  • Tests of memory and thinking abilities
  • Electroencephalography (EEG) recordings
  • MRI scans
  • Four ultrasound treatments at fortnightly intervals

Trial dates

This trial is accepting participants from October 2022 to October 2023.

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