The Pilot Study of Medical Device-Neuclare for Patients With Mild Cognitive Disorder and Early Dementia

A Prospective Pilot Study to Evaluate Efficacy and Safety of Medical Device-Neuclare in Patient With Mild Cognitive Disorder and Early Dementia

This clinical trial aims to explore the effectiveness and safety of cognitive function improvement of Neuclare, a science medical device, for patients with mild cognitive impairment and early Alzheimer's disease.

Through methods such as Trail Making Test Black & White, Attention Questionnaire Scale(AQS), Neuropsychiatric Inventory (NPI), etc, cognitive function improvement before and after using Neuclare will be evaluated.

Study Overview

• Status: Recruiting
• Conditions: Dementia, Mild; Cognitive Disorder Mild
• Intervention / Treatment: Device: Neuclare

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Seonkyu Kim; Phone Number: +82-10-4324-5147; Email: ksksbs@deepsonbio.com

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Hwaseong-si, Gyeonggi-do, Korea, Republic of, 18450
      • Recruiting
      • Hallym University Dongtan Sacred Heart Hospital
      • Contact: Seonkyu Kim; Phone Number: +82 10-4324-5147; Email: ksksbs@deepsonbio.com
      • Principal Investigator: Jaeho Kim, M.D. Ph.D
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Recruiting
      • Seoul National University Bundang Hospital
      • Principal Investigator: SangYun Kim, M.D. Ph.D
      • Contact: Seonkyu Kim; Phone Number: +82-10-4324-5147; Email: ksksbs@deepsonbio.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults aged 55 to 90
• Patients who meet "Probable Alzheimer's disease" and "Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV)" criteria for dementia
• Patients with CDR (clinical dementia rating) from 0.5 to 1 and MMSE-II over 18
• Upon hearing and fully understanding the detailed explanation of this clinical trial, a person who has voluntarily decided to participate and agreed in writing to comply with the precautions

Exclusion Criteria:

• Patient with pathological lesions in the brain identified by MRI
• Patients with metabolic disorders such as thyroid dysfunction, hyperglycemia, hypoglycemia, liver or kidney dysfunction, and long-term use of drugs that will cause cognitive decline (e.g., anticholinergic drugs)
• History of epileptic seizures or depression or psychiatric abnormalities or with visual acuity and fluctuations in cognitive decline
• History of psychiatric disorder other than the inclusion criteria.
• A person with a severe history of cancer/tuberculosis
• A person who has or is taking psychiatric or peripheral/central nervous system drugs
• A person who has contact dermatitis or sensitive skin abnormalities
• Patients with a high fever of 40 degrees or higher based on eardrum body temperature
• A person whose bleeding is identified within the last 3 months due to a common procedure/surgery that may affect vital signs
• A person who is unable to perform MRI tests
• Pregnant women
• Patient with calcification in the brain identified by CT
• Patient with allergic to contrast agents such as Definity or Gadovist
• Other cases where the investigator judged that it is difficult to participate in the study;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; The patient with mild cognitive disorder and early dementia who will be treated with the medical device-Neuclare	Device: Neuclare; It is used to stimulate the brain for a certain period of time to improve cognitive impairment in patients with cognitive disorder. In this clinical trial, it is used for patients with mild cognitive disorder and demincia symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Trail Making Test Black & White Score : From Baseline to Week 5	Compare with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as evaluated by Trail Making Test Black & White Score	Week 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Attention Questionnaire Scale : From Baseline to Week 5	Compare with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as evaluated by Attention Questionnaire Scale	Week 5
Change of Neuropsychiatric Inventory Score : From Baseline to Week 5	Compare with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as evaluated by Neuropsychiatric Inventory score	Week 5
Change of Quality of life-AD Score : From Baseline to Week 5	Compare with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as evaluated by Quality of life-AD Score	Week 5
Change of MMSE-II Score : From Baseline to Week 5	Compare with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as evaluated by MMSE-II Score	Week 5
Change of glucose metabolic rate in brain measured by FDG PET-CT : From Baseline to Week 5	Compare glucose metabolic rate with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as measured by FDG PET-CT	Week 5
Change of Aβ oligomer density measured by MDS-OAβ test result : From Baseline to Week 5	Compare Aβ oligomer density with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as measured by MDS-OAβ test	Week 5
change of beta-amyloid deposition measured by Amyloid PET-CT : From Baseline to Week 5	change of beta-amyloid deposition with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as measured by Amyloid PET-CT	Week 5

Collaborators and Investigators

• Sponsor: Deepsonbio
• Investigators: Principal Investigator: SangYun Kim, M.D. ph.D, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2022
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): March 30, 2024

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): December 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia; Cognition Disorders
• Other Study ID Numbers: Deepsonbio_Neuclare

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No