Focused Ultrasound for Memory Loss

(LIFUPMEMEMOT Trial)

Overseen By Natalie M Rotstein

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Head injury, Alcohol abuse, Psychiatric illness, Cancer, Neurologic illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

21 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial investigates whether using gentle sound waves to stimulate specific brain areas can help older adults improve their memory and emotional control. The technique aims to increase brain activity and blood flow in these regions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Low Intensity Focused Ultrasound Pulsation for memory loss?

Research shows that focused ultrasound can safely open the blood-brain barrier, allowing treatments to reach the brain more effectively. In studies with Alzheimer's patients, this method has been shown to improve memory function and reduce disease-related brain changes without causing significant side effects. ^{1 2 3 4 5}

Is focused ultrasound for memory loss safe for humans?

There is no specific safety data available for focused ultrasound for memory loss in humans, but related research on similar treatments in animals has shown potential risks, such as brain changes linked to Alzheimer's disease. ^{6 7 8 9 10}

How does the treatment Low Intensity Focused Ultrasound Pulsation for memory loss differ from other treatments?

Low Intensity Focused Ultrasound Pulsation is unique because it uses sound waves to target specific brain areas, potentially restoring memory function and slowing the progression to Alzheimer's disease. Unlike traditional drug treatments, this non-invasive approach directly interacts with brain structures involved in memory, offering a novel way to address memory impairment. ^{11 12 13 14 15}

Research Team

Taylor P Kuhn, PhD

Principal Investigator

UCLA Longevity Center

Eligibility Criteria

This trial is for right-handed English speakers aged 35-65 with learning disabilities, memory loss, or cognitive issues. It's not suitable for those with MRI contraindications like metal implants, major psychiatric or neurological illnesses, significant head injuries, alcohol/substance abuse history, or cancer.

Inclusion Criteria

English is my primary language.

I am between 35 and 65 years old.

You must be someone who primarily uses their right hand for tasks.

Exclusion Criteria

You have had a head injury serious enough to need medical care.

You have a history of drinking too much or being addicted to alcohol.

History of major psychiatric illness requiring treatment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LIFUP to the amygdala and entorhinal cortex in a crossover design

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Low Intensity Focused Ultrasound Pulsation
• SHAM Ultrasound

Trial Overview The study tests if Low Intensity Focused Ultrasound Pulsation (LIFUP) can improve memory by stimulating the brain's medial temporal lobe non-invasively. Participants will be randomly assigned to receive either LIFUP or a SHAM ultrasound that mimics treatment without real effects.

Participant Groups

Group I: Entorhinal Cortex first, then Amygdala Experimental Treatment 2 Interventions

Low Intensity focused ultrasound pulsation (LIFUP) will be administered to the entorhinal cortex while participants are in the MRI scanner. Then, 2 weeks later, amygdala LIFUP will be administered.

Group II: Amygdala first, then Entorhinal Cortex Experimental Treatment 2 Interventions

Low Intensity focused ultrasound pulsation (LIFUP) will be administered to the amygdala while participants are in the MRI scanner. Then, 2 weeks later, entorhinal cortex LIFUP will be administered.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Findings from Research

Focused ultrasound (FUS) combined with microbubbles has been shown to safely open the blood-brain barrier in animal studies, allowing therapeutic agents to enter the brain and potentially improve cognitive function in Alzheimer's disease.

Human studies indicate that repeated FUS treatments are well tolerated with minimal side effects, and they may enhance brain blood flow and neural function, which is associated with cognitive improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Applications of Focused Ultrasound (FUS) in Alzheimer's Disease Treatment: A Systematic Review on Both Animal and Human Studies. Liu, X., Naomi, SSM., Sharon, WL., et al.[2021]

In a phase I safety trial involving five patients with early to moderate Alzheimer's disease, focused ultrasound successfully and safely opened the blood-brain barrier without causing serious adverse events or worsening cognitive function over three months.

Although the procedure was safe, exploratory analysis showed no significant changes in beta-amyloid levels post-treatment, indicating that while the method is feasible, further research is needed to assess its efficacy in reducing Alzheimer's pathology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood-brain barrier opening in Alzheimer's disease using MR-guided focused ultrasound. Lipsman, N., Meng, Y., Bethune, AJ., et al.[2022]

Androgen deprivation therapy (ADT) is a key treatment for prostate cancer, effective throughout the disease course, including in metastatic, localized, and recurrent cases.

While ADT is beneficial, it comes with significant side effects such as osteoporosis, increased fracture risk, diabetes, cardiovascular issues, and sexual dysfunction, necessitating a multidisciplinary approach to patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Androgen deprivation therapy: indications, methods of utilization, side effects and their management. Magee, DE., Singal, RK.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Noninvasive hippocampal blood-brain barrier opening in Alzheimer's disease with focused ultrasound. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Alzheimer disease in a mouse model: MR imaging-guided focused ultrasound targeted to the hippocampus opens the blood-brain barrier and improves pathologic abnormalities and behavior. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The Applications of Focused Ultrasound (FUS) in Alzheimer's Disease Treatment: A Systematic Review on Both Animal and Human Studies. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Ultrasound as a versatile tool for short- and long-term improvement and monitoring of brain function. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Blood-brain barrier opening in Alzheimer's disease using MR-guided focused ultrasound. [2022]

6. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Induction of RhoGAP and pathological changes characteristic of Alzheimer's disease by UAHFEMF discharge in rat brain. [2019]

7. Canada pubmed.ncbi.nlm.nih.gov

Androgen deprivation therapy: indications, methods of utilization, side effects and their management. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Neuropsychological effects of cranial radiation: current knowledge and future directions. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Hippocampal dose volume histogram predicts Hopkins Verbal Learning Test scores after brain irradiation. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Impact of androgen deprivation therapy on mood, cognition, and risk for AD. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Disorders of memory. [2019]

12. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Bridging neurocognitive aging and disease modification: targeting functional mechanisms of memory impairment. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Cognitive neuroscience of human memory. [2019]

14. England pubmed.ncbi.nlm.nih.gov

The efficacy of imagery mnemonics in memory remediation. [2019]

15. England pubmed.ncbi.nlm.nih.gov

Hippocampal abnormalities in amnesic patients revealed by high-resolution magnetic resonance imaging. [2006]