Mild Cognitive ImpairmentNCT07239310
Neuclare Device for Temporary Improvement of Executive Function in Patients With Mild Cognitive Impairment and Prodromal Alzheimer's Disease
A study testing Participants receive Neuclare Device while continuing their cognitive medication in people with Mild Cognitive Impairment and Alzheimer's Disease(AD), run by Deepsonbio at 7 sites in South Korea.
Trial summary
This study is a multicenter, randomized, double-blind, parallel-group, prospective confirmatory clinical trial designed to evaluate whether the Neuclare medical device can temporarily improve executive function (planning and problem-solving abilities) in adults with mild cognitive impairment or very early Alzheimer's… Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer's Disease(AD)
- What is being tested?
- Participants receive Neuclare Device while continuing their cognitive medication
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 20 Nov 2025to Jan 2027
- 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 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 55 to 90 years.
- Diagnosed with mild cognitive impairment (MCI) or early Alzheimer's disease according to the 2024 National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria.
- mild cognitive impairment/very mild Alzheimer's disease with CDR 0.5-1 and MMSE-II ≥18.
- On stable cognitive therapy medications for at least 1 month.
- Voluntary participation with signed informed consent.
Who cannot join
- Patients with structural brain lesions detected on brain MRI (e.g., cerebral edema, intracerebral hemorrhage, cerebral infarction, cerebrovascular malformation, brain tumor, etc.).
- Patients with uncontrolled metabolic disorders such as thyroid dysfunction, hypoglycemia, or hepatic/renal impairment, or those on long-term medications that may cause cognitive impairment (e.g., anticholinergic drugs).
- Patients with a history of epileptic seizures, depression, or psychiatric disorders; patients experiencing visual hallucinations or fluctuating cognitive decline.
- Patients with psychiatric disorders outside of the inclusion criteria.
- Patients with a history of severe diseases such as cancer or tuberculosis.
- Patients with a history of or currently taking psychoactive drugs or medications affecting the central or peripheral nervous system.
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- Patients with contact dermatitis or other skin hypersensitivity conditions.
- Patients with fever ≥ 40°C as measured by tympanic temperature.
- Patients who have experienced bleeding within the past 3 months due to procedures or surgeries that may affect vital signs.
- Patients unable to undergo MRI.
- Pregnant patients.
- Patients with clinical brain calcification observed on computed tomography (CT) scans.
- Patients with known allergies to contrast agents such as Definity or Gadovist.
- Any other condition deemed by the investigator to make participation in the clinical trial inappropriate.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
South Korea7 sites, 7 recruiting
- Recruiting
Soonchunhyang University Cheonan Hospital
Cheonan, Chungcheongnam-do, 31151
Won Yi Cho, 82+10-4584-5512, dnjsdl_tmdgh@naver.com
Young Soon Yang
- Recruiting
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, 18450
Ah Jeon Yang, 82+10-2983-5373, hallymhaha@naver.com
Jae Ho Kim
- Recruiting
Inha University Hospital
Incheon, Gyeonggi-do, 22332
Joo Hye Kwon, 82+10-7420-0903, juhyejjang@naver.com
Sung Hye Choi
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Young Sook Ahn, 82+10-9877-6630, hyun717@nate.com
Jung Min Pyun
- Recruiting
Ewha Womans University Seoul Hospital
Seoul, 07804
Eun Kyung Kim, 82+10-8576-0994, iouy1128@naver.com
Ji Hyang Jeong
- Recruiting
Ewha Womans University Mokdong Hospital
Seoul, 07985
Ji Suk Lim, 82+10-2810-1647, jsskin@naver.com
Gun Ha Kim
- Recruiting
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247
Hee Kyung Hong, 82+10-7459-3102, haidy126@naver.com
Yong Soo Shim
About this study
Official title: A Prospective, Multicenter, Randomized, Double-Blind, Parallel-Group, Confirmatory Clinical Trial to Verify the Efficacy and Safety of the Cognitive Improvement Effect on Executive Function in Medication-Treated Patients With Mild Cognitive Impairment and Prodromal Alzheimer's Disease Using the Neuclare Physical Device for Medical Use
This study is a multicenter, randomized, double-blind, parallel-group, prospective confirmatory clinical trial designed to evaluate whether the Neuclare medical device can temporarily improve executive function (planning and problem-solving abilities) in adults with mild cognitive impairment or very early Alzheimer's disease.
Participants will continue their current medication and be randomly assigned to receive either the Neuclare device (treatment group) or a sham device (control group). The device will be applied to the brain three times per week for four weeks. Both participants and study staff are blinded to the group assignment. Safety and adverse events will be closely monitored throughout the study.
Read more
During the trial, assessments will include attention, cognitive function, daily living activities, brain imaging (Amyloid PET-CT), blood biomarkers, and quality of life (EQ-5D-5L).
The goal of this study is to determine whether the Neuclare device, in combination with standard medication, can safely provide temporary improvements in executive function.
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease(AD)
- Being tested
- Participants receive Neuclare Device while continuing their cognitive medication, Participants receive Sham Neuclare Device while continuing their cognitive medication
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants receive Neuclare Device while continuing their cognitive medicationDevice
Participants in this arm receive the Neuclare physical device applied to the cerebral cortex, receiving low-intensity ultrasound stimulation less than 30 minutes per session, three times per week for 4 weeks.
This intervention is intended to temporarily improve executive function in patients with mild cognitive impairment and prodromal Alzheimer's disease.
Participants receive Sham Neuclare Device while continuing their cognitive medicationDevice
Participants in this arm receive a sham version of the Neuclare device, which mimics the appearance and procedure of the active device but does not deliver therapeutic ultrasound.
The sham device is applied less than 30 minutes per session, three times per week for 4 weeks, while participants continue their cognitive medication.
This arm serves as a control for comparison with the active intervention.
| Study group | Role | What they receive |
|---|---|---|
| Neuclare Device | Experimental | Participants receive standard medication plus Neuclare device therapy three times per week for 4 weeks. Receives: Device: Participants receive Neuclare Device while continuing their cognitive medication |
| Sham Device | Placebo comparator | Participants receive standard medication plus sham Neuclare device therapy. Receives: Device: Participants receive Sham Neuclare Device while continuing their cognitive medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Trail Making Test-A Completion Time from Baseline to Week 5
The primary efficacy outcome is the change in Trail Making Test-A (TMT-A) completion time from baseline to Week 5 after application of the investigational device. Descriptive statistics will be presented for each treatment arm. Between-group comparisons of the change from baseline will be analyzed using ANCOVA with baseline scores as a covariate.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start20 Nov 2025
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deepsonbio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239310
- Sponsor's protocol ID
- BIO-Altheon
- Other IDs
- 1861
- Status last verified
- Aug 2026
- First submitted
- 16 Nov 2025
- Last updated
- 7 Aug 2026
- 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 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Double-Blind, Parallel-Group, Confirmatory Clinical Trial to Verify the Efficacy and Safety of the Cognitive Improvement Effect on Executive Function in Medication-Treated Patients With Mild Cognitive Impairment and Prodromal Alzheimer's Disease Using the Neuclare Physical Device for Medical Use
- ClinicalTrials.gov ID
- NCT07239310
- Acronym / sponsor ID
- BIO-Altheon
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease(AD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- DeepsonbioIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 20 Nov 2025 (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 multicenter, randomized, double-blind, parallel-group, prospective confirmatory clinical trial designed to evaluate whether the Neuclare medical device can temporarily improve executive function (planning and problem-solving abilities) in adults with mild cognitive impairment or very early Alzheimer's disease.
Participants will continue their current medication and be randomly assigned to receive either the Neuclare device (treatment group) or a sham device (control group). The device will be applied to the brain three times per week for four weeks. Both participants and study staff are blinded to the group assignment. Safety and adverse events will be closely monitored throughout the study.
During the trial, assessments will include attention, cognitive function, daily living activities, brain imaging (Amyloid PET-CT), blood biomarkers, and quality of life (EQ-5D-5L).
The goal of this study is to determine whether the Neuclare device, in combination with standard medication, can safely provide temporary improvements in executive function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuclare Device | Experimental | Device: Participants receive Neuclare Device while continuing their cognitive medicationParticipants receive standard medication plus Neuclare device therapy three times per week for 4 weeks. |
| Sham Device | Placebo comparator | Device: Participants receive Sham Neuclare Device while continuing their cognitive medicationParticipants receive standard medication plus sham Neuclare device therapy. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 55 to 90 years.
- Diagnosed with mild cognitive impairment (MCI) or early Alzheimer's disease according to the 2024 National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria.
- mild cognitive impairment/very mild Alzheimer's disease with CDR 0.5-1 and MMSE-II ≥18.
- On stable cognitive therapy medications for at least 1 month.
- Voluntary participation with signed informed consent.
Key exclusion criteria (14 listed)
- Patients with structural brain lesions detected on brain MRI (e.g., cerebral edema, intracerebral hemorrhage, cerebral infarction, cerebrovascular malformation, brain tumor, etc.).
- Patients with uncontrolled metabolic disorders such as thyroid dysfunction, hypoglycemia, or hepatic/renal impairment, or those on long-term medications that may cause cognitive impairment (e.g., anticholinergic drugs).
- Patients with a history of epileptic seizures, depression, or psychiatric disorders; patients experiencing visual hallucinations or fluctuating cognitive decline.
- Patients with psychiatric disorders outside of the inclusion criteria.
- Patients with a history of severe diseases such as cancer or tuberculosis.
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 |
|---|---|---|
| Participants receive Neuclare Device while continuing their cognitive medicationParticipants in this arm receive the Neuclare physical device applied to the cerebral cortex, receiving low-intensity ultrasound stimulation less than 30 minutes per session, three times per week for 4 weeks. This intervention is intended to temporarily improve executive function in patients with mild cognitive impairment and prodromal Alzheimer's disease. | Device | Neuclare Device |
| Participants receive Sham Neuclare Device while continuing their cognitive medicationParticipants in this arm receive a sham version of the Neuclare device, which mimics the appearance and procedure of the active device but does not deliver therapeutic ultrasound. The sham device is applied less than 30 minutes per session, three times per week for 4 weeks, while participants continue their cognitive medication. This arm serves as a control for comparison with the active intervention. | Device | Sham Device |
Primary outcome
Change in Trail Making Test-A Completion Time from Baseline to Week 5
Time frame: 5 weeks
The primary efficacy outcome is the change in Trail Making Test-A (TMT-A) completion time from baseline to Week 5 after application of the investigational device. Descriptive statistics will be presented for each treatment arm. Between-group comparisons of the change from baseline will be analyzed using ANCOVA with baseline scores as a covariate.
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 7 Aug 2026.
- 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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participants receive Neuclare Device while continuing their cognitive medication in people with Mild Cognitive Impairment and Alzheimer's Disease(AD), run by Deepsonbio at 7 sites in South Korea.
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 14 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 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea. 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.
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 Sung Kyung Lee (82+10-9877-8173, sklee@deepsonbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Trail Making Test-A Completion Time from Baseline to Week 5 (time frame: 5 weeks). 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 7 Aug 2026.