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NCT03347084 · ClinicalTrials.gov registry record · NA
Deep Brain Stimulation with LIFUP for Mild Cognitive Impairment and Mild Alzheimer's Disease
A NA study of Alzheimer Disease and Mild Cognitive Impairment, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- NA
- Development phase
- 2
- Enrollment target
- 1
- Study location
NCT03347084 is a NA study of Alzheimer Disease and Mild Cognitive Impairment that has completed, run by University of California, Los Angeles. The registered enrollment target is 2 participants, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03347084, a NA study of Alzheimer Disease and Mild Cognitive Impairment, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- NA
- Development phase
- 2 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the proposed study is to determine the feasibility of brief brain stimulation, using a device called Low Intensity Focused Ultrasound Pulsation (LIFUP), for persons with mild cognitive impairment (MCI) or mild (early-stage) Alzheimer's disease (AD). As a secondary aim, the investigators will explore whether this brief intervention is associated with improvements in cognitive functioning immediately and one week following the intervention. Subjects will be randomly assigned to one of two experimental groups: either the LIFUP administration will be designed to increase the activity of neurons in a certain part of the brain or decrease the activity of neurons. The investigators will study up to 8 subjects with MCI or mild AD. Initially, subjects will undergo a screening assessment with a study physician to determine medical and psychiatric history, establish AD diagnosis, and undergo a blood draw, if standard recent labs for dementia and EKG are unavailable. Subjects that meet criteria and agree to participate in the study will undergo a follow-up visit. In the baseline measurement visit, participants will first undergo neuropsychological testing. Participants will be randomly assigned to one of two LIFUP pulsing paradigms. Participants will then be administered four successive LIFUP treatments while the participants are in a functional magnetic resonance imaging (MRI). Sixty minutes following the administration, participants will undergo a second neuropsychological test. A final follow-up assessment will be administered at one week.
Conditions Studied
Interventions
- DEVICE Excitation
- DEVICE Inhibition
Study Locations (1)
California
- UCLA Semel Institute - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2018-11-10 |
| Est. Completion | 2023-10-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03347084
The ClinicalTrials.gov registry entry for NCT03347084 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (100% lower). The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which Excitation is the first listed.
NCT03347084 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT03347084 about?
NCT03347084 is a clinical study titled "Deep Brain Stimulation with LIFUP for Mild Cognitive Impairment and Mild Alzheimer's Disease". The purpose of the proposed study is to determine the feasibility of brief brain stimulation, using a device called Low Intensity Focused Ultrasound Pulsation (LIFUP), for persons with mild cognitive impairment (MCI) or mild (early-stage) Alzheimer's disease (AD). As a secondary aim, the investigato...
What is the current status of trial NCT03347084?
This trial is currently completed. It is a NA study. The enrollment target is 2 participants. The study started on 2018-11-10. Estimated completion is 2023-10-01.
What conditions does trial NCT03347084 study?
This clinical trial studies the following conditions: Alzheimer Disease, Mild Cognitive Impairment, Deep Brain Stimulation, Brain Imaging.
What interventions are being tested in trial NCT03347084?
The interventions under investigation include: Excitation (DEVICE), Inhibition (DEVICE).
Who is sponsoring clinical trial NCT03347084?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03347084 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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