What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease include cholinesterase inhibitors (donepezil, rivastigmine, galantamine), memantine, and aducanumab. Cholinesterase inhibitors can cause gastrointestinal side effects such as nausea, vomiting, and diarrhea, as well as muscle cramps and fatigue. Memantine is generally well-tolerated but can cause dizziness, headache, confusion, and constipation. Aducanumab, a newer treatment, has been associated with amyloid-related imaging abnormalities (ARIA), including brain swelling and microhemorrhages, as well as headache, falls, and diarrhea. The ExAblate Model 4000 Type 2.0 System, which disrupts the blood-brain barrier, is still under investigation, and its safety profile is not fully established.

What prior FDA approvals exist?

The FDA has approved several treatments for Alzheimer's Disease, focusing primarily on symptom management and slowing disease progression. Notable drugs include cholinesterase inhibitors like donepezil and galantamine, which help improve cognitive function, and memantine, which regulates glutamate activity to support memory and learning. While the ExAblate Model 4000 Type 2.0 System is being studied for its potential to disrupt the blood-brain barrier in Alzheimer's patients, there are no current FDA-approved treatments specifically targeting blood-brain barrier disruption for Alzheimer's Disease.

What other types of research exist?

Promising alternatives for Alzheimer's Disease treatment in 2024 include: 1) RNA interference therapies like patisiran and inotersen, which target transthyretin production; 2) Monoclonal antibodies such as aducanumab and lecanemab, which target amyloid-beta plaques; and 3) Emerging therapies like tau-targeting agents and anti-sense oligonucleotides. These therapies have shown potential in clinical trials for modifying disease progression and improving cognitive function.

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Ultrasound Therapy

ExAblate BBB Disruption for Alzheimer's Disease

N/A

Recruiting

Research Sponsored by InSightec

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or Female between 50-85 years of age

Probable Alzheimer's Disease (AD)

Must not have

Significant cardiac disease or unstable hemodynamic status

Relative contraindications to ultrasound contrast agent or PET amyloid tracer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a device that uses ultrasound waves to temporarily open the brain's protective barrier in patients with Alzheimer's Disease. The goal is to see if this can help medications reach the brain better. Focused ultrasound with microbubbles has been studied recently and shows promise for opening the brain's protective barrier in Alzheimer's disease treatment.

Who is the study for?

This trial is for people aged 50-85 with probable Alzheimer's Disease who can walk and report sensations during the procedure. They must have been on stable Alzheimer's medication for at least 3 months if applicable. Exclusions include significant heart disease, MRI contraindications, bleeding disorders, severe liver or kidney issues, untreated sleep apnea, seizure history, current participation in other trials, chronic lung problems, HIV positive status or certain genetic risk factors.

What is being tested?

The study tests the safety and effectiveness of the ExAblate Model 4000 Type 2.0 System to temporarily disrupt the blood-brain barrier in patients with Alzheimer's Disease. This disruption could potentially allow better delivery of treatments to the brain.

What are the potential side effects?

Potential side effects may include discomfort from wearing a head frame during treatment and risks associated with MRI procedures such as reactions to contrast agents used during scanning.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 50 and 85 years old.

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I have been diagnosed with probable Alzheimer's Disease.

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I can walk on my own without help.

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I am between 50 and 85 years old.

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I have been diagnosed with probable Alzheimer's Disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have serious heart problems or unstable blood pressure.

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I cannot have certain imaging agents due to health risks.

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I have a history of bleeding problems.

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I have a diagnosed blood vessel disorder in my brain or body.

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I am experiencing severe depression and may be at risk of harming myself.

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I cannot have a lumbar puncture due to health reasons.

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I have sleep apnea that hasn't been treated or controlled.

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I have a history of seizures or epilepsy.

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My kidney function is severely impaired.

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I have a long-term lung condition.

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I have two copies of the ApoE4 gene.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Device and procedure related adverse events

Other study objectives

BBB Disruption and Closure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Blood Brain Barrier (BBB) DisruptionExperimental Treatment1 Intervention

ExAblate Model 4000 Type 2.0 System

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Alzheimer's Disease (AD) include cholinesterase inhibitors and NMDA receptor antagonists. Cholinesterase inhibitors, such as donepezil, increase acetylcholine levels in the brain, which can help improve cognitive function. NMDA receptor antagonists, like memantine, protect neurons from damage caused by excessive glutamate activity. Emerging therapies, such as blood-brain barrier (BBB) disruption, aim to enhance drug delivery to the brain, potentially improving treatment efficacy. These mechanisms are important for AD patients as they offer different strategies to manage symptoms and slow disease progression.