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

Deepsonbio2 sites in 1 country20 target enrollmentOctober 7, 2022

ConditionsDementia, Mild Cognitive Disorder Mild

Overview

Phase: N/A
Intervention: Not specified
Conditions: Dementia, Mild
Sponsor: Deepsonbio
Enrollment: 20
Locations: 2
Primary Endpoint: Change of Trail Making Test Black & White Score : From Baseline to Week 5
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 7, 2022

End Date

March 30, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Deepsonbio

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

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