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Procedure

Neuromodulation for Alzheimer's Disease

N/A
Recruiting
Research Sponsored by Ali Rezai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males and non-pregnant females, aged 45-85 years
Must meet the clinical criteria for MCI due to Alzheimer's disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 7 and 30 days
Awards & highlights

Study Summary

This trial is being conducted to test the safety and tolerability of a new treatment method called LIFU for patients with mild cognitive impairment caused by Alzheimer's disease.

Who is the study for?
This trial is for men and women aged 45-85 who can communicate during the procedure, have mild cognitive impairment due to Alzheimer's, and are not pregnant. Participants must be able to consent and if taking certain Alzheimer's medications, they should be on a stable dose for at least 45 days.Check my eligibility
What is being tested?
The study is testing Low-Intensity Focused Ultrasound (LIFU) as a neuromodulation treatment in patients with mild cognitive impairment from Alzheimer's. It’s an early-stage study focused on understanding how safe and tolerable this technique is.See study design
What are the potential side effects?
Since it’s an early feasibility study focusing on safety, specific side effects of LIFU aren't listed but generally could include discomfort at the site of ultrasound application or temporary changes in brain function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 45 and 85 years old and not pregnant.
Select...
My condition is mild cognitive impairment due to Alzheimer's.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 7 and 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 7 and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cognitive Change
Occurrence of Treatment Emergent Adverse Events
Secondary outcome measures
Imaging Changes

Trial Design

1Treatment groups
Experimental Treatment
Group I: NeuromodulationExperimental Treatment1 Intervention
Subjects meeting eligibility criteria will undergo Exablate low intensity focused ultrasound neuromodulation

Find a Location

Who is running the clinical trial?

Ali RezaiLead Sponsor
3 Previous Clinical Trials
49 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit in terms of patient enrollment for this medical study?

"Indeed, the details provided on clinicaltrials.gov affirm that this trial is currently in the recruitment phase. The trial was initially posted on October 12th, 2023 and its latest update occurred on December 19th, 2023. The study aims to enroll a total of 15 patients from one designated site."

Answered by AI

Are there any ongoing efforts to enroll participants for this study at the moment?

"Indeed, the information available on clinicaltrials.gov confirms that this trial is presently in the recruitment phase. The initial posting of the trial was recorded on October 12th, 2023 and its most recent update occurred on December 19th, 2023. For this study, a total of 15 participants are being sought from a single designated site."

Answered by AI

Is the age threshold for participation in this study set at 65 years or higher?

"This study is open to individuals ranging from 45 to 85 years old."

Answered by AI

Is there a possibility for me to partake in this clinical trial?

"This medical trial is seeking a specific group of individuals with Alzheimer's disease, between the ages of 45 and 85. It is crucial that potential candidates meet certain requirements: they must possess the ability to effectively communicate their sensations during the LIFU procedure, be either male or non-pregnant females aged 45-85 years old, demonstrate capacity and willingness to provide informed consent, fulfill clinical criteria for Mild cognitive impairment (MCI) caused by Alzheimer's disease, and if currently undergoing treatment with an AChEI and/or memantine, have maintained a consistent dosage for at least 45 days."

Answered by AI

Who else is applying?

What site did they apply to?
Rockefeller Neuroscience Institute at West Virginia University
What portion of applicants met pre-screening criteria?
Met criteria

What questions have other patients asked about this trial?

How long should we plan to stay for trials and treatment?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

My wife saw the report on 60 Minutes and felt it would be beneficial to me if I enrolled in this treatment.
PatientReceived no prior treatments
~10 spots leftby Sep 2025