Using low-intensity focused ultrasound to treat mild cognitive impairment in Alzheimer's patients
Early Feasibility Study of Low-Intensity Focused Ultrasound (LIFU) Neuromodulation in Patients With Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
This study is testing if low-intensity focused ultrasound can safely help people with mild cognitive impairment from Alzheimer's feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 45 Years to 85 Years |
| Sex | All |
| Sponsor | West Virginia University Academic / other |
| Locations | 1 site (Morgantown, West Virginia) |
| Trial ID | NCT05997030 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are males and non-pregnant females aged 45-85 years who meet the clinical criteria for MCI due to Alzheimer's disease.
Not a fit: Patients with significant skull abnormalities or those who cannot undergo MR-imaging due to implanted devices or claustrophobia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive treatment option for patients with mild cognitive impairment due to Alzheimer's disease.
How similar studies have performed: While the use of LIFU for neuromodulation is a novel approach, similar studies in other conditions have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Morgantown, West Virginia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.