Transcranial Ultrasound Stimulation for Alzheimer's Disease
(NDD-01 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called transcranial ultrasound stimulation, a non-invasive therapy, to aid individuals with Alzheimer's and similar brain conditions. The goal is to determine if this treatment can safely enhance brain function, memory, behavior, and overall quality of life. Suitable candidates for this trial include those diagnosed with Alzheimer's, Parkinson's, or mild cognitive issues, who are stable and can read English. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could improve future treatments for brain conditions.
Do I need to stop taking my current medications for the trial?
The trial team will review your current medications to ensure they don't increase the risk of seizures or interact with the study. They will decide if you need to stop any medications.
What prior data suggests that transcranial ultrasound stimulation is safe for Alzheimer's patients?
Research has shown that transcranial ultrasound stimulation is generally well-tolerated by patients. One study found that it improved thinking skills and brain function, offering potential benefits without major safety concerns. Another source highlights that this technique is non-invasive, meaning it doesn't involve surgery and is considered safe to use. These findings suggest that the treatment is safe for people with Alzheimer's disease, with no significant harmful effects reported.12345
Why are researchers excited about this trial?
Researchers are excited about transcranial ultrasound stimulation for Alzheimer's disease because it offers a novel, non-invasive way to potentially slow or alter the disease's progression. Unlike current treatments, which mainly focus on managing symptoms through medications like cholinesterase inhibitors and memantine, this technique uses focused ultrasound waves to target specific brain regions involved in Alzheimer's pathology. This approach could lead to more precise modulation of brain activity and possibly impact the underlying disease mechanisms, which is a significant departure from existing symptom-focused therapies.
What evidence suggests that transcranial ultrasound stimulation is effective for Alzheimer's disease?
Studies have shown that using sound waves on the head, known as transcranial ultrasound stimulation (TUS), may help people with Alzheimer's disease by improving brain function. Research indicates that TUS can reach deep brain areas, such as the hippocampus, which is crucial for memory. In one study, patients demonstrated better thinking abilities after TUS treatment. Another study found that TUS might help the brain use energy more efficiently, enhancing cognitive skills. These early findings suggest TUS could be a promising approach for Alzheimer's, although more research is needed to confirm its long-term benefits. Participants in this trial will receive open-label transcranial focused ultrasound neuromodulation targeting a brain region involved in disease pathology.12367
Who Is on the Research Team?
Jay Sanguinetti, PhD
Principal Investigator
Sanmai Technologies, PBC
Are You a Good Fit for This Trial?
This trial is for adults aged 18-80 with Alzheimer's, Parkinson's, or mild cognitive impairment who can read English and are medically stable. They must not have psychiatric conditions like OCD or bipolar disorder, drug/alcohol addiction, significant neurological issues unrelated to their diagnosis, metal implants incompatible with TUS/MRI, uncontrolled heart conditions, recent cancer history (less than 5 years remission), or a high risk of seizures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive transcranial focused ultrasound neuromodulation targeting a brain region involved in disease pathology
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Transcranial Ultrasound Stimulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sanmai Technologies PBC dba Sanmai
Lead Sponsor
Acacia Research
Collaborator
University of New Mexico
Collaborator
The Regenesis Project
Collaborator
BrainMind
Collaborator