Alzheimer DiseaseNCT05997030
Low-Intensity Focused Ultrasound (LIFU) Neuromodulation
A study testing low intensity focused ultrasound (LIFU) in people with Alzheimer Disease, run by Ali Rezai at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- low intensity focused ultrasound (LIFU)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2023to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rockefeller Neuroscience Institute at West Virginia University
Morgantown, West Virginia, 26505
Marc W Haut, PhD, 304-293-6276, mhaut@hsc.wvu.edu
About this study
Official title: Early Feasibility Study of Low-Intensity Focused Ultrasound (LIFU) Neuromodulation in Patients With Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
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.
Read the detailed description
The primary objective is to evaluate the safety, feasibility and tolerability of LIFU as an adjunct neuromodulatory treatment for MCI due to AD
- Conditions
- Alzheimer Disease
- Being tested
- low intensity focused ultrasound (LIFU)
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low intensity focused ultrasound (LIFU)Device
Subjects will undergo undergo a single LIFU of the target brain region
| Study group | Role | What they receive |
|---|---|---|
| Neuromodulation | Experimental | Subjects meeting eligibility criteria will undergo Exablate low intensity focused ultrasound neuromodulation Receives: Device: low intensity focused ultrasound (LIFU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 7 and days after study procedure
Cognitive Change
Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Measured: baseline and 7 days after procedure
Secondary outcomes (1)
Imaging Changes
Changes in brain metabolism and connectivity using PET and fMRI
Measured: baseline, 7 and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start12 Oct 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ali Rezai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ali Rezai, West Virginia University
- Investigators
- Ali Rezai, MD, Principal investigator, WVU Rockefeller Neuroscience Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997030
- Sponsor's protocol ID
- RNI_NMD_AD01
- Status last verified
- Nov 2025
- First submitted
- 4 Aug 2023
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study of Low-Intensity Focused Ultrasound (LIFU) Neuromodulation in Patients With Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05997030
- Acronym / sponsor ID
- RNI_NMD_AD01
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Ali RezaiUniversity, hospital or other
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective is to evaluate the safety, feasibility and tolerability of LIFU as an adjunct neuromodulatory treatment for MCI due to AD
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuromodulation | Experimental | Device: low intensity focused ultrasound (LIFU)Subjects meeting eligibility criteria will undergo Exablate low intensity focused ultrasound neuromodulation |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low intensity focused ultrasound (LIFU)Subjects will undergo undergo a single LIFU of the target brain region | Device | Neuromodulation |
Primary outcome
Occurrence of Treatment Emergent Adverse Events
Time frame: baseline and 7 and days after study procedure
Safety will be assessed by recording all adverse events that are treatment related. Each Adverse Event will be documented for patterns of occurence.
Cognitive Change
Time frame: baseline and 7 days after procedure
Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
1 secondary outcome
Imaging Changes
Time frame: baseline, 7 and 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali Rezai, MD principal investigator
WVU Rockefeller Neuroscience Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low intensity focused ultrasound (LIFU) in people with Alzheimer Disease, run by Ali Rezai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Haut, PhD (3042936276, mhaut@hsc.wvu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Treatment Emergent Adverse Events (time frame: baseline and 7 and days after study procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.