Alzheimer's Disease(ad) / Participants receive Neuclare Device while continuing their cognitive medication / Participants receive Sham Neuclare Device while continuing their cognitive medic · Interventional Study

Neuclare Device for Temporary Improvement of Executive Function in Patients With Mild Cognitive Impairment and Prodromal Alzheimer's Disease

ClinicalTrials.gov · August 7, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a prospective, multicenter, double-blind, randomized controlled trial of the Neuclare device for temporary improvement of executive function in adults with mild cognitive impairment or prodromal Alzheimer's disease. The trial is currently recruiting and has not yet reported results; no efficacy or safety data are available in this registry record.

What was studied

Interventional, Randomized, Parallel, Double masking, Treatment purpose. Mild Cognitive Impairment, Alzheimer's Disease(AD); age from 55 Years; to 90 Years. Intervention: Neuclare Device. Compared with: Sham Device — Placebo Comparator. n = 138. 7 sites: South Korea.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

Results from this trial, once published, will inform whether the Neuclare device provides a safe, temporary improvement in executive function as an adjunct to standard medication. Clinicians should not apply findings from this registry record to practice; await results publication.

Plain-language summary

This is a registered trial currently recruiting participants with no results yet reported; the design is rigorous but outcome data are absent, precluding any evidence claim beyond the planned methodology.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Change in Trail Making Test-A Completion Time from Baseline to Week 5 (assessed at 5 weeks)

DesignInterventional, Randomized, Parallel, Double masking, Treatment purpose

PopulationMild Cognitive Impairment, Alzheimer's Disease(AD); age from 55 Years; to 90 Years

Sample size138

InterventionNeuclare Device

ComparatorSham Device — Placebo Comparator

Setting7 sites: South Korea

Reported figures

Quoted from the source exactly as published.

Planned sample size138

Primary outcome measureChange in Trail Making Test-A Completion Time from Baseline to Week 5

Primary outcome assessment timepoint5 weeks

Device application frequencyThree times per week for four weeks

Clinical bottom line

Caveats

This is a registry record only; no results are reported and enrollment is ongoing.
Phase designation listed as 'NA' in registry; confirmatory language in brief summary suggests Phase 3 intent but is not formally stated.
No sample size justification, power calculation, or effect size assumption is provided in this registry record.
Secondary and exploratory outcomes (attention, daily living, brain imaging, biomarkers, quality of life) are mentioned but specific outcome measures and analysis plans are not detailed.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Multicenter, randomized, double-blind, parallel-group, prospective confirmatory design.

Directness

strong

Primary outcome directly measures executive function via Trail Making Test-A completion time.

Consistency

insufficient

No results reported; consistency cannot be assessed at registry stage.

Risk of bias

moderate

Blinding of participants and staff documented; sham comparator present; no results data to assess selective reporting.

Sample adequacy

moderate

Planned enrollment 138 participants; adequacy depends on effect size assumptions not stated here.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07239310). This is a study registration, not published results. Lead sponsor: Deepsonbio. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 138 participants (ESTIMATED). Conditions: Mild Cognitive Impairment, Alzheimer's Disease(AD). Interventions: DEVICE: Participants receive Neuclare Device while continuing their cognitive medication; DEVICE: Participants receive Sham Neuclare Device while continuing their cognitive medication. Primary outcome measures: Change in Trail Making Test-A Completion Time from Baseline to Week 5 , 5 weeks. Brief 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 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Alzheimer's Disease(ad)Participants receive Neuclare Device while continuing their cognitive medicationNCT07239310DeepsonbioParticipants receive Sham Neuclare Device while continuing their cognitive medicMild Cognitive Impairment