15 Participants Needed

LIFU for Alzheimer's Disease

MH
KE
KE
Overseen ByKiley Everson, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ali Rezai
Must be taking: AChEI, Memantine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on AChEI or memantine, you must have been on a stable dose for at least 45 days.

What data supports the effectiveness of the treatment Low-Intensity Focused Ultrasound (LIFU) for Alzheimer's Disease?

Research shows that Low-Intensity Focused Ultrasound (LIFU) can open the blood-brain barrier (a protective layer around the brain) and potentially improve brain activity. In a pilot study, LIFU was explored for its effects on Alzheimer's patients, focusing on brain metabolism and cognitive function, although its full effectiveness and safety in humans are still being studied.12345

How is the LIFU treatment for Alzheimer's disease different from other treatments?

LIFU (Low-Intensity Focused Ultrasound) is unique because it uses sound waves to temporarily open the blood-brain barrier, allowing for potential delivery of treatments directly to the brain, which is not possible with most other Alzheimer's treatments.23456

What is the purpose of this trial?

This study is a prospective, single-center, single-arm early feasibility study, to establish safety and tolerability of LIFU for neuromodulation in patients with mild cognitive impairment ( MCI) due to Alzheimer's disease.

Research Team

AR

Ali Rezai, MD

Principal Investigator

WVU Rockefeller Neuroscience Institute

Eligibility Criteria

This trial is for men and women aged 45-85 who can communicate during the procedure, have mild cognitive impairment due to Alzheimer's, and are not pregnant. Participants must be able to consent and if taking certain Alzheimer's medications, they should be on a stable dose for at least 45 days.

Inclusion Criteria

You can express feelings during the LIFU procedure.
You possess the capacity to provide informed consent.
I am between 45 and 85 years old and not pregnant.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Exablate low intensity focused ultrasound neuromodulation

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

Treatment Details

Interventions

  • Low-Intensity Focused Ultrasound (LIFU)
Trial Overview The study is testing Low-Intensity Focused Ultrasound (LIFU) as a neuromodulation treatment in patients with mild cognitive impairment from Alzheimer's. It’s an early-stage study focused on understanding how safe and tolerable this technique is.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: NeuromodulationExperimental Treatment1 Intervention
Subjects meeting eligibility criteria will undergo Exablate low intensity focused ultrasound neuromodulation

Low-Intensity Focused Ultrasound (LIFU) is already approved in United States, Canada, Japan for the following indications:

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Approved in United States as Low-Intensity Focused Ultrasound (LIFU) for:
  • Mild Cognitive Impairment (MCI) due to Alzheimer's disease
  • Research use for neuromodulation
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Approved in Canada as Low-Intensity Focused Ultrasound (LIFU) for:
  • Research use for neuromodulation in Alzheimer's disease
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Approved in Japan as Low-Intensity Focused Ultrasound (LIFU) for:
  • Research use for neuromodulation in Alzheimer's disease

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ali Rezai

Lead Sponsor

Trials
6
Recruited
90+

Findings from Research

Low-intensity focused ultrasound (LIFUS) is a promising noninvasive technique that can modulate human brain activity, showing effects like suppressing cortical evoked potentials and altering sensory/motor task outcomes in studies involving human subjects.
The proposed mechanisms of LIFUS include cavitation and direct effects on neural ion channels, suggesting it could be developed for non-surgical treatments of neurological disorders, although optimal protocols are still being refined.
Low-intensity ultrasound neuromodulation: An overview of mechanisms and emerging human applications.Fomenko, A., Neudorfer, C., Dallapiazza, RF., et al.[2019]
In a pilot study involving four patients with Alzheimer's disease, low-intensity transcranial focused ultrasound (tFUS) was found to increase cerebral glucose metabolism in specific brain regions, indicating potential therapeutic effects.
Patients showed mild improvements in cognitive functions, such as memory and executive function, after the tFUS treatment, and no adverse events were reported, suggesting that this method may be safe for use in humans.
A pilot clinical study of low-intensity transcranial focused ultrasound in Alzheimer's disease.Jeong, H., Im, JJ., Park, JS., et al.[2021]
High-density gel polymer matrices are effective couplants for low-intensity focused ultrasound (LIFU) neuromodulation, showing low acoustic attenuation (3.3%) and minimal beam distortion, making them suitable for clinical use.
The study highlights the importance of using standardized methods for preparing these gels to ensure consistent performance, as factors like thickness and de-gassing can significantly affect acoustic transmission and pressure attenuation.
Evaluation of a Novel Acoustic Coupling Medium for Human Low-Intensity Focused Ultrasound Neuromodulation Applications.Strohman, A., In, A., Stebbins, K., et al.[2023]

References

Low-intensity ultrasound neuromodulation: An overview of mechanisms and emerging human applications. [2019]
A pilot clinical study of low-intensity transcranial focused ultrasound in Alzheimer's disease. [2021]
Evaluation of a Novel Acoustic Coupling Medium for Human Low-Intensity Focused Ultrasound Neuromodulation Applications. [2023]
Preliminary effects of low-intensity focused ultrasound treatment program for cancer-related neuropathic pain. [2022]
Characterization of passive permeability after low intensity focused ultrasound mediated blood-brain barrier disruption in a preclinical model. [2023]
Proteomics Reveals the Effect of Low-Intensity Focused Ultrasound on Spasticity After Spinal Cord Injury. [2023]
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