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

Dementia, Mild Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05633095
• Other study ID #: Deepsonbio_Neuclare
• Status: Recruiting
• Phase: N/A
• Start date: October 7, 2022
• Est. completion date: March 30, 2024

Study information

• Verified date: November 2022
• Source: Deepsonbio
• Contact: Seonkyu Kim
• Phone: +82-10-4324-5147
• Email: ksksbs[@]deepsonbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 30, 2024
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 90 Years

Eligibility

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;

Related Conditions & MeSH terms

• Cognition Disorders
• Dementia
• Dementia, Mild

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Dongtan Sacred Heart Hospital	Hwaseong-si	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Deepsonbio

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change of Aß oligomer density measured by MDS-OAß test result : From Baseline to Week 5	Compare Aß oligomer density with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as measured by MDS-OAß test	Week 5