Neuclare Device for Temporary Improvement of Executive Function in Patients With Mild Cognitive Impairment and Prodromal Alzheimer's Disease
NCT ID: NCT07239310
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
138 participants
INTERVENTIONAL
2025-11-20
2026-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Neuclare Device
Participants receive standard medication plus Neuclare device therapy three times per week for 4 weeks.
Participants receive Neuclare Device while continuing their cognitive medication
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.
Sham Device
Participants receive standard medication plus sham Neuclare device therapy.
Participants receive Sham Neuclare Device while continuing their cognitive medication
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.
Interventions
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Participants receive Neuclare Device while continuing their cognitive medication
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 medication
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.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with probable Alzheimer's disease according to NINCDS-ADRDA criteria and DSM-IV criteria for dementia,
3. or mild cognitive impairment/very mild Alzheimer's disease with CDR 0.5-1 and MMSE-II ≥18.
4. On stable cognitive therapy medications for at least 1 month.
5. Voluntary participation with signed informed consent.
5. Patients with a history of severe diseases such as cancer or tuberculosis.
6. Patients with a history of or currently taking psychoactive drugs or medications affecting the central or peripheral nervous system.
7. Patients with contact dermatitis or other skin hypersensitivity conditions.
8. Patients with fever ≥ 40°C as measured by tympanic temperature.
9. Patients who have experienced bleeding within the past 3 months due to procedures or surgeries that may affect vital signs.
10. Patients unable to undergo MRI.
11. Pregnant patients.
12. Patients with clinical brain calcification observed on computed tomography (CT) scans.
13. Patients with known allergies to contrast agents such as Definity or Gadovist.
14. Any other condition deemed by the investigator to make participation in the clinical trial inappropriate.
Exclusion Criteria
2. 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).
3. Patients with a history of epileptic seizures, depression, or psychiatric disorders; patients experiencing visual hallucinations or fluctuating cognitive decline.
55 Years
90 Years
ALL
No
Sponsors
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Deepsonbio
INDUSTRY
Responsible Party
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Locations
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Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1861
Identifier Type: OTHER
Identifier Source: secondary_id
BIO-Altheon
Identifier Type: -
Identifier Source: org_study_id
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