Recruiting

LIFU

Sponsor:

Ali Rezai

Code:

NCT05997030

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

low intensity focused ultrasound (LIFU)

Study Details

Brief 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.

Conditions

Alzheimer Disease

Study ID

NCT05997030

Start date

Oct 12, 2023

Status verified date

Nov, 2025

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Neuromodulation

Subjects meeting eligibility criteria will undergo Exablate low intensity focused ultrasound neuromodulation

Interventions

low intensity focused ultrasound (LIFU)

Subjects will undergo undergo a single LIFU of the target brain region

Primary outcome measure

  • Occurrence of Treatment Emergent Adverse Events [ Time Frame: baseline and 7 and days after study procedure ]
  • Cognitive Change [ Time Frame: baseline and 7 days after procedure ]

Central Contacts and Locations

Central contacts

Marc Haut, PhD

3042936276mhaut@hsc.wvu.edu

Locations

Rockefeller Neuroscience Institute at West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26505

Contacts

Marc W Haut, PhD

304-293-6276mhaut@hsc.wvu.edu

More Information

Sponsor

Ali Rezai

Last update posted

Nov 24, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ali Rezai on 2025-11-24.