Alzheimer DiseasePhase 1/2NCT06135051
Ultrasonic Neuromodulation for Treatment of Cognitive Impairment
A Phase 1/2 study testing Diadem prototype in people with Alzheimer Disease and Dementia, run by University of Utah at 1 site in United States.
Trial summary
This study will evaluate a new form of non-invasive deep brain therapy for individuals with Alzheimer's disease. Low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Alzheimer Disease, Dementia, Cognitive Impairment
- What is being tested?
- Diadem prototype
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2024to 21 Aug 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild cognitive impairment or mild dementia due to Alzheimer's disase (AD) with confirmed AD biomarkers (Amyloid PET or CSF)
- Age 65-80
- MOCA > 18
Who cannot join
- Evidence of cerebral amyloid angiopathy or stroke within 1 year
- Clinical symptoms or findings suggestive of alternative diagnosis or co-pathology
- Inability to complete MRI
- Suicidal ideation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deep Brain Therapy With Low-intensity Ultrasound for Treatment of Cognitive Impairment
This study will evaluate a new form of non-invasive deep brain therapy for individuals with Alzheimer's disease. Low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial. The trial will evaluate brain target engagement using magnetic resonance imaging, PET imaging, and numerical scales of cognitive performance.
- Conditions
- Alzheimer Disease, Dementia, Cognitive Impairment
- Being tested
- Diadem prototype
- Medical subject headings
- Alzheimer Disease, Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diadem prototypeDevice
The device delivers low-intensity ultrasonic waves into specific brain targets.
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation | Experimental | Low-intensity transcranial focused ultrasound stimulation of deep brain targets affected by Alzheimer's disease. Receives: Device: Diadem prototype |
| Sham stimulation | Sham comparator | Sham stimulation that applies the device in the same way as verum but only delivers auditory sounds correspoding to the ultrasonic pulses. Receives: Device: Diadem prototype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment Test for Dementia (MoCA)
The MoCA is a 30-point test to detect cognitive impairment. Scores range from 0 (poor) and 30 (perfect).
Measured: Up to 3 months following study initiation
Hamilton Depression Rating Scale (HDRS-17)
This 17-item questionnaire rates the severity of depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. The scores range from 0 (no symptoms) to 52 (worst possible).
Measured: Up to 3 months following study initiation
Amyloid PET
PET (positron emission tomography) combined with fluorine-18 labelled radiotracers provide brain scans that are interpreted as either amyloid-beta positive or negative.
Measured: Up to 3 months following study initiation
Secondary outcomes (3)
Hopkins Verbal Learning Test-Revised (HVLT-R)
HVLT-R is a verbal memory test with 12 words learned over three trials, with the correct words summed for the Total Recall score (range = 0 (worst) - 36 (best)). The Delayed Recall score is the number of correct words recalled after a 20 - 25-minute delay (range = 0 (worst) - 12 (best)).
Measured: Up to 3 months following study initiation
Digit Span Memory Test
A standard test for working memory. In this test, a list of random numbers or letters is presented on a computer screen at the rate of one per second. The test begins with three numbers, increasing until the person commits errors. The average digit span for normal adults without error is seven plus or minus two. The higher the number, the more patent the working memory.
Measured: Up to 3 months following study initiation
Trail Making Test, Part A and B
The test probes visual scanning and working memory. The task is to connect a set of 25 dots as quickly as possible while maintaining accuracy. The faster the completion of Part A and Part B, the better.
Measured: Up to 3 months following study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start18 Aug 2024
- Primary completion21 Aug 2024
- Study completion21 Aug 2024
Why it stopped: IRB administrative closure
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.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Kubanek, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135051
- Sponsor's protocol ID
- IRB_00173042
- Status last verified
- Apr 2025
- First submitted
- 8 Nov 2023
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Therapy With Low-intensity Ultrasound for Treatment of Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06135051
- Acronym / sponsor ID
- IRB_00173042
- Conditions
- Alzheimer Disease, Dementia, Cognitive Impairment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IRB administrative closure
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 18 Aug 2024 (actual)
- Primary completion
- 21 Aug 2024 (actual)
- Study completion
- 21 Aug 2024 (actual)
- First posted
- 18 Nov 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 will evaluate a new form of non-invasive deep brain therapy for individuals with Alzheimer's disease. Low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial. The trial will evaluate brain target engagement using magnetic resonance imaging, PET imaging, and numerical scales of cognitive performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active stimulation | Experimental | Device: Diadem prototypeLow-intensity transcranial focused ultrasound stimulation of deep brain targets affected by Alzheimer's disease. |
| Sham stimulation | Sham comparator | Device: Diadem prototypeSham stimulation that applies the device in the same way as verum but only delivers auditory sounds correspoding to the ultrasonic pulses. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mild cognitive impairment or mild dementia due to Alzheimer's disase (AD) with confirmed AD biomarkers (Amyloid PET or CSF)
- Age 65-80
- MOCA > 18
Key exclusion criteria (4 listed)
- Evidence of cerebral amyloid angiopathy or stroke within 1 year
- Clinical symptoms or findings suggestive of alternative diagnosis or co-pathology
- Inability to complete MRI
- Suicidal ideation
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 |
|---|---|---|
| Diadem prototypeThe device delivers low-intensity ultrasonic waves into specific brain targets. | Device | Active stimulation, Sham stimulation |
Primary outcome
Montreal Cognitive Assessment Test for Dementia (MoCA)
Time frame: Up to 3 months following study initiation
The MoCA is a 30-point test to detect cognitive impairment. Scores range from 0 (poor) and 30 (perfect).
Hamilton Depression Rating Scale (HDRS-17)
Time frame: Up to 3 months following study initiation
This 17-item questionnaire rates the severity of depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. The scores range from 0 (no symptoms) to 52 (worst possible).
Amyloid PET
Time frame: Up to 3 months following study initiation
PET (positron emission tomography) combined with fluorine-18 labelled radiotracers provide brain scans that are interpreted as either amyloid-beta positive or negative.
3 secondary outcomes
Hopkins Verbal Learning Test-Revised (HVLT-R)
Time frame: Up to 3 months following study initiation
Digit Span Memory Test
Time frame: Up to 3 months following study initiation
Trail Making Test, Part A and B
Time frame: Up to 3 months following study initiation
Results and safety
The study was stopped early (reason given: IRB administrative closure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Diadem prototype in people with Alzheimer Disease and Dementia, run by University of Utah 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 25 May 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: IRB administrative closure). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment Test for Dementia (MoCA) (time frame: Up to 3 months following study initiation). The study lists 3 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 25 May 2025.