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Focused Ultrasound for Early Alzheimer's Disease (LIFUP-MCIAD Trial)

N/A
Recruiting
Led By Susan Y Bookheimer, PhD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 50-90
Normal or corrected-to-normal hearing or vision
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre-lifup)
Awards & highlights

LIFUP-MCIAD Trial Summary

This trial is testing whether a new brain stimulation technique can improve memory in people with early Alzheimer's disease.

Who is the study for?
This trial is for English-speaking, right-handed individuals aged 50-90 with amnestic MCI who can consent and have normal or corrected vision/hearing. Excluded are those with MR-incompatible metal implants, certain genetic disorders, psychiatric conditions other than controlled anxiety/depression, severe organ diseases, recent cancer treatments to the head/neck area, autoimmune disorder treatments, substance abuse history (excluding nicotine/caffeine), significant head injuries or neurological disorders.Check my eligibility
What is being tested?
The study tests if Low-Intensity Focused Ultrasound Pulsation (LIFUP) targeting the entorhinal cortex can activate brain regions connected to memory and improve memory function in a dose-dependent manner. It also examines how blood-based AD biomarkers and hippocampal volume changes relate to LIFUP outcomes.See study design
What are the potential side effects?
Potential side effects of LIFUP may include discomfort at the site of application, headache during or after treatment, temporary hearing changes due to ultrasound noise exposure during treatment sessions.

LIFUP-MCIAD Trial 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 90 years old.
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My hearing and vision are normal, or corrected to be normal.
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I have been diagnosed with amnestic mild cognitive impairment.

LIFUP-MCIAD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Arteries
Brain
Secondary outcome measures
Change in Brief Visual Memory Test Scores
Change in Verbal Learning Test Scores
Post-hoc biomarker analysis of APOE-4 status as a predictor of tFUS efficacy
+2 more

LIFUP-MCIAD Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: LIFUP Dose Group 3Active Control1 Intervention
Administration of low intensity focused ultrasound (LIFUP) dose level 3 to the entorhinal cortex.
Group II: LIFUP Dose Group 1Active Control1 Intervention
Administration of low intensity focused ultrasound (LIFUP) dose level 1 to the entorhinal cortex.
Group III: LIFUP Dose Group 2Active Control1 Intervention
Administration of low intensity focused ultrasound (LIFUP) dose level 2 to the entorhinal cortex.
Group IV: Sham LIFUPPlacebo Group1 Intervention
No administration of LIFUP. The device will be affixed to the user's head but not turned on. Additionally, if at the end of the study, the treatment has been shown to be effective, placebo subjects will be offered a free session using the optimally effective dose, if they consented to being contacted for this purpose.

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,659 Previous Clinical Trials
28,004,585 Total Patients Enrolled
University of California, Los AngelesLead Sponsor
1,525 Previous Clinical Trials
10,279,594 Total Patients Enrolled
Susan Y Bookheimer, PhDPrincipal InvestigatorUCLA Psychiatry & Biobehavioral Sciences

Media Library

Low-Intensity Focused Ultrasound Pulsation (LIFUP) (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05417555 — N/A
Mild Cognitive Impairment Research Study Groups: LIFUP Dose Group 3, LIFUP Dose Group 1, LIFUP Dose Group 2, Sham LIFUP
Mild Cognitive Impairment Clinical Trial 2023: Low-Intensity Focused Ultrasound Pulsation (LIFUP) Highlights & Side Effects. Trial Name: NCT05417555 — N/A
Low-Intensity Focused Ultrasound Pulsation (LIFUP) (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05417555 — N/A

Frequently Asked Questions

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

What do researchers hope to gain from this experiment?

"This 40 minute trial has been designed to measure changes in Perfusion Arterial Spin Labeling (ASL) fMRI Signal throughout the Brain. Secondary outcomes involve assessing memory through Rey Verbal Learning Test Scores, which involves recalling a list of 15 words over 5 trials and 30 minutes later as an indicator for short-term and long-term memory respectively; post-hoc biomarker analysis of plasma AB42/40 ratio as predictor of tFUS efficacy, where values lower than 0.160 suggest high risk for Alzheimer's disease; lastly, post-hoc biomarker analysis involving APOE-4 status to predict"

Answered by AI

Is recruitment still underway for this clinical procedure?

"The information posted on clinicaltrials.gov attests to this study not currently recruiting patients, having been initially launched on September 1st 2022 and last updated 2 days later. Nonetheless, there are 602 other active trials that are looking for participants at the present moment."

Answered by AI

Are people over 55 years old being accepted as participants in this research endeavor?

"Candidates aged 50 and above, but below 90 years old are being admitted to this clinical study."

Answered by AI

Who is eligible to join this medical experiment?

"This research requires the recruitment of 144 individuals aged 50 to 90, all with a pre-existing Deep Brain Stimulation treatment. Additionally, these participants must be diagnosed with Amnestic Mild cognitive impairment (MCI), English speaking, right handed; and have normal hearing or vision that can be corrected as necessary. Further, they must also agree to provide informed consent through UBACC protocols put forward in 2007 by Jeste et al."

Answered by AI
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~88 spots leftby Jul 2026