Using low-intensity focused ultrasound to treat mild cognitive impairment in Alzheimer's patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety, feasibility, and tolerability of low-intensity focused ultrasound (LIFU) as a neuromodulatory treatment for patients with mild cognitive impairment (MCI) due to Alzheimer's disease. It is a prospective, single-center, single-arm early feasibility study designed to gather preliminary data on the use of LIFU in this patient population. Participants will undergo LIFU treatment while their ability to communicate sensations during the procedure will be monitored. The study aims to establish whether LIFU can be a viable adjunct treatment for MCI associated with Alzheimer's.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Males and non-pregnant females, aged 45-85 years
* Able and willing to give informed consent
* Must meet the clinical criteria for MCI due to Alzheimer's disease
* If receiving concurrent treatment with an AChEI and/or memantine, has been on a stable dose for at least 45 days
* Able to communicate sensations during the LIFU procedure

Exclusion Criteria:

* Unable to undergo MR-imaging because of implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent make-up or small metal fragments in the eye that welders and other metal workers may have, or if candidates are uncomfortable in small spaces (have claustrophobia).
* Participants with more than 30% of the skull area traversed by the sonication pathway are covered by scars, scalp disorders (e.g., eczema), atrophy of the scalp, or implanted objects in the skull or the brain.
* Participants with a history of seizure disorder.
* Participants with clinically significant chronic pulmonary disorders e.g., severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area.
* Participant does not speak English
* Participant is pregnant or planning to be pregnant

Where it's running

• Rockefeller Neuroscience Institute at West Virginia University
  Morgantown, West Virginia, United States Recruiting

Study contacts

• Principal investigator: Ali Rezai, MD — WVU Rockefeller Neuroscience Institute
• Study coordinator: Marc Haut, PhD
• Email: mhaut@hsc.wvu.edu
• Phone: 3042936276

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.