LIFUP Dose Group 1 for Mild Cognitive Impairment
Phase-Based Progress Estimates
Effectiveness
Safety
UCLA Semel Institute for Neuroscience and Behavior, Los Angeles, CAMild Cognitive Impairment+2 MoreLow-Intensity Focused Ultrasound Pulsation (LIFUP) - Device
Study Summary
This trial is testing whether a new brain stimulation technique can improve memory in people with early Alzheimer's disease.
Eligible Conditions
- Mild Cognitive Impairment
- Deep Brain Stimulation
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 5 Secondary · Reporting Duration: 4 years
4 years
Post-hoc biomarker analysis of APOE-4 status as a predictor of tFUS efficacy
Post-hoc biomarker analysis of plasma AB42/40 ratio as a predictor of tFUS efficacy
Post-hoc biomarker analysis of plasma ptau as a predictor of tFUS efficacy
40 minutes
Arteries
Brain
48 hours
Change in Brief Visual Memory Test Scores
Change in Verbal Learning Test Scores
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
LIFUP Dose Group 1
1 of 4
LIFUP Dose Group 3
1 of 4
LIFUP Dose Group 2
1 of 4
Sham LIFUP
1 of 4
Active Control
Non-Treatment Group
144 Total Participants · 4 Treatment Groups
Primary Treatment: LIFUP Dose Group 1 · Has Placebo Group · N/A
LIFUP Dose Group 1
Device
ActiveComparator Group · 1 Intervention: Low-Intensity Focused Ultrasound Pulsation (LIFUP) · Intervention Types: DeviceLIFUP Dose Group 3
Device
ActiveComparator Group · 1 Intervention: Low-Intensity Focused Ultrasound Pulsation (LIFUP) · Intervention Types: DeviceSham LIFUP
Device
ShamComparator Group · 1 Intervention: Low-Intensity Focused Ultrasound Pulsation (LIFUP) · Intervention Types: DeviceLIFUP Dose Group 2
Device
ActiveComparator Group · 1 Intervention: Low-Intensity Focused Ultrasound Pulsation (LIFUP) · Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 years
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,420 Previous Clinical Trials
6,748,702 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,443 Previous Clinical Trials
4,246,843 Total Patients Enrolled
Susan Y Bookheimer, PhDPrincipal InvestigatorUCLA Psychiatry & Biobehavioral Sciences
Taylor P Kuhn, PhDPrincipal InvestigatorUCLA Psychiatry & Biobehavioral Sciences
2 Previous Clinical Trials
48 Total Patients Enrolled
Eligibility Criteria
Age 50 - 90 · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are right-handed.
You have no hearing or vision impairments, or if you wear a correction device, it brings your hearing or vision back to normal.
References
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Frequently Asked Questions
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" - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer