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

Not Applicable

Recruiting

• Conditions: Cognitive Disorder Mild; Dementia, Mild
• Interventions: Device: Neuclare

• Registration Number: NCT05633095
• Lead Sponsor: Deepsonbio

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-07
• Status Verified: 2022-11
• Study First Submitted: 2022-11-21
• Study First Submitted QC: 2022-11-21
• Study First Posted: 2022-12-01
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-24
• Primary Completion: 2023-07-31
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Neuclare	The patient with mild cognitive disorder and early dementia who will be treated with the medical device-Neuclare

Primary Outcome Measures

Name	Time	Method
Change of Trail Making Test Black & White Score : From Baseline to Week 5	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

Name	Time	Method
Change of Attention Questionnaire Scale : From Baseline to Week 5	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	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 Aβ oligomer density measured by MDS-OAβ test result : From Baseline to Week 5	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
Change of MMSE-II Score : From Baseline to Week 5	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 glucose metabolic rate in brain measured by FDG PET-CT : From Baseline to Week 5	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 Quality of life-AD Score : From Baseline to Week 5	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 beta-amyloid deposition measured by Amyloid PET-CT : From Baseline to Week 5	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

Trial Locations

Locations (2)

Hallym University Dongtan Sacred Heart Hospital; 🇰🇷 Hwaseong-si, Gyeonggi-do, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of