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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 90
Healthy Volunteers: f
View:

• Adults aged 55 to 90 years.

• Diagnosed with probable Alzheimer's disease according to NINCDS-ADRDA criteria and DSM-IV criteria for dementia,

• or 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.

Locations
Other Locations
Republic of Korea
Hallym University Dongtan Sacred Heart Hospital
NOT_YET_RECRUITING
Hwaseong-si
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Ewha Womans University Mokdong Hospital
RECRUITING
Seoul
Contact Information
Primary
Sung Kyung Lee
sklee@deepsonbio.com
82+10-9877-8173
Time Frame
Start Date: 2025-11-20
Estimated Completion Date: 2026-07
Participants
Target number of participants: 138
Treatments
Experimental: Neuclare Device
Participants receive standard medication plus Neuclare device therapy three times per week for 4 weeks.
Placebo_comparator: Sham Device
Participants receive standard medication plus sham Neuclare device therapy.
Related Therapeutic Areas
Sponsors
Leads: Deepsonbio

This content was sourced from clinicaltrials.gov

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