Focused Ultrasound for Alzheimer's Disease

(FUS-AD Trial)

This trial explores a new approach to treating Alzheimer's Disease (AD) by using focused ultrasound to temporarily open the blood-brain barrier, a protective layer around the brain, to assess its safety and effectiveness. Researchers aim to reduce harmful proteins linked to Alzheimer’s, potentially improving memory and behavior. The trial is suitable for individuals over 50 with mild cognitive impairment (early memory problems) or Alzheimer's who can provide informed consent. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

The trial does not specify if you need to stop taking your current medications. However, if you are on anticoagulant therapy or have taken amyloid-reducing agents like aducanumab or lecanemab, you may not be eligible to participate.

Research has shown that focused ultrasound treatments are well-tolerated by people with Alzheimer's disease. Earlier studies found that this method can safely open the blood-brain barrier, a protective layer around the brain, without damaging brain tissue. In some cases, it even helped reduce levels of harmful proteins associated with Alzheimer's. A meta-analysis, which combines results from several studies, confirmed that this approach is safe and effective in making the blood-brain barrier more permeable. This means treatments can reach the brain more easily. Overall, focused ultrasound appears to be a promising and safe option for Alzheimer's patients.¹²³⁴⁵

Researchers are excited about focused ultrasound treatment for Alzheimer's because it offers a novel approach by temporarily opening the blood-brain barrier (BBB). Unlike traditional treatments that primarily focus on managing symptoms with medications like cholinesterase inhibitors and memantine, this technique uses neuronavigation-guided ultrasound waves paired with microbubbles to enhance drug delivery directly to the brain. This method could potentially improve the effectiveness of existing treatments by allowing therapeutic agents to reach brain areas that are otherwise difficult to access, potentially slowing disease progression more effectively.

Research has shown that focused ultrasound (FUS), which participants in this trial will receive, can safely and effectively open the blood-brain barrier (BBB) in people with Alzheimer's disease. This technique, used with tiny bubbles, helps treatments reach the brain more easily. Studies in mice demonstrated that FUS alone can lower levels of amyloid beta and tau proteins, which are linked to Alzheimer's, and improve memory. Early human trials also indicated that FUS can reduce these harmful proteins. Overall, FUS offers a promising method to make the brain more accessible to treatments for Alzheimer's.²⁴⁵⁶⁷