Low-Intensity Focused Ultrasound (LIFU) Neuromodulation

Alzheimer Disease Clinical Trial

Official title:

Early Feasibility Study of Low-Intensity Focused Ultrasound (LIFU) Neuromodulation in Patients With Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05997030
• Other study ID #: RNI_NMD_AD01
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: December 2023
• Source: West Virginia University
• Contact: Marc Haut, PhD
• Phone: 3042934816
• Email: mhaut[@]hsc.wvu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a prospective, single-center, single-arm early feasibility study, to establish safety and tolerability of LIFU for neuromodulation in patients with mild cognitive impairment ( MCI) due to Alzheimer's disease.

Description:

The primary objective is to evaluate the safety, feasibility and tolerability of LIFU as an adjunct neuromodulatory treatment for MCI due to AD

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

Inclusion Criteria:

• Males and non-pregnant females, aged 45-85 years
• Able and willing to give informed consent
• Must meet the clinical criteria for MCI due to Alzheimer's disease
• If receiving concurrent treatment with an AChEI and/or memantine, has been on a stable dose for at least 45 days
• Able to communicate sensations during the LIFU procedure

Exclusion Criteria:

• Unable to undergo MR-imaging because of implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent make-up or small metal fragments in the eye that welders and other metal workers may have, or if candidates are uncomfortable in small spaces (have claustrophobia).
• Participants with more than 30% of the skull area traversed by the sonication pathway are covered by scars, scalp disorders (e.g., eczema), atrophy of the scalp, or implanted objects in the skull or the brain.
• Participants with a history of seizure disorder.
• Participants with clinically significant chronic pulmonary disorders e.g., severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area.
• Participant does not speak English
• Participant is pregnant or planning to be pregnant

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Device:
• low intensity focused ultrasound (LIFU)
Subjects will undergo undergo a single LIFU of the target brain region

Locations

Country	Name	City	State
United States	Rockefeller Neuroscience Institute at West Virginia University	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Ali Rezai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Treatment Emergent Adverse Events	Safety will be assessed by recording all adverse events that are treatment related. Each Adverse Event will be documented for patterns of occurence.	baseline and 7 and days after study procedure
Primary	Cognitive Change	Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)	baseline and 7 days after procedure
Secondary	Imaging Changes	Changes in brain metabolism and connectivity using PET and fMRI	baseline, 7 and 30 days