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The Pilot Study of Medical Device-Neuclare for Patients With Mild Cognitive Disorder and Early Dementia | Clinical Trials | Clareo Health

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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

NCT05633095•Deepsonbio

View on ClinicalTrials.gov

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.

Eligibility

Age

55 - 90 years

Sex

ALL

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
•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
+4 more criteria

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

Locations (2)

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Key Dates

Start Date

October 7, 2022

Primary Completion Date

July 31, 2023

Completion Date

March 30, 2024

Last Updated

March 24, 2023

Enrollment

ESTIMATED participants

Conditions

Dementia, MildCognitive Disorder Mild

Interventions

Neuclare

DEVICE

Contacts

Seonkyu Kim

CONTACT

+82-10-4324-5147 ksksbs@deepsonbio.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 24, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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