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

Primary Purpose

Dementia, Mild, Cognitive Disorder Mild

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Neuclare
Sponsored by
Deepsonbio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia, Mild

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Hallym University Dongtan Sacred Heart HospitalRecruiting
  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

The patient with mild cognitive disorder and early dementia who will be treated with the medical device-Neuclare

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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
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
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

Full Information

First Posted
November 21, 2022
Last Updated
March 22, 2023
Sponsor
Deepsonbio
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1. Study Identification

Unique Protocol Identification Number
NCT05633095
Brief Title
The Pilot Study of Medical Device-Neuclare for Patients With Mild Cognitive Disorder and Early Dementia
Official Title
A Prospective Pilot Study to Evaluate Efficacy and Safety of Medical Device-Neuclare in Patient With Mild Cognitive Disorder and Early Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deepsonbio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Mild, Cognitive Disorder Mild

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
The patient with mild cognitive disorder and early dementia who will be treated with the medical device-Neuclare
Intervention Type
Device
Intervention Name(s)
Neuclare
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Trail Making Test Black & White Score : From Baseline to Week 5
Description
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
Time Frame
Week 5
Secondary Outcome Measure Information:
Title
Change of Attention Questionnaire Scale : From Baseline to Week 5
Description
Compare with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as evaluated by Attention Questionnaire Scale
Time Frame
Week 5
Title
Change of Neuropsychiatric Inventory Score : From Baseline to Week 5
Description
Compare with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as evaluated by Neuropsychiatric Inventory score
Time Frame
Week 5
Title
Change of Quality of life-AD Score : From Baseline to Week 5
Description
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
Time Frame
Week 5
Title
Change of MMSE-II Score : From Baseline to Week 5
Description
Compare with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as evaluated by MMSE-II Score
Time Frame
Week 5
Title
change of beta-amyloid deposition measured by Amyloid PET-CT : From Baseline to Week 5
Description
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
Time Frame
Week 5
Title
Change of glucose metabolic rate in brain measured by FDG PET-CT : From Baseline to Week 5
Description
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
Time Frame
Week 5
Title
Change of Aβ oligomer density measured by MDS-OAβ test result : From Baseline to Week 5
Description
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
Time Frame
Week 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seonkyu Kim
Phone
+82-10-4324-5147
Email
ksksbs@deepsonbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SangYun Kim, M.D. ph.D
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hallym University Dongtan Sacred Heart Hospital
City
Hwaseong-si
State/Province
Gyeonggi-do
ZIP/Postal Code
18450
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seonkyu Kim
Phone
+82 10-4324-5147
Email
ksksbs@deepsonbio.com
First Name & Middle Initial & Last Name & Degree
Jaeho Kim, M.D. Ph.D
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seonkyu Kim
Phone
+82-10-4324-5147
Email
ksksbs@deepsonbio.com
First Name & Middle Initial & Last Name & Degree
SangYun Kim, M.D. Ph.D

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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