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Recruiting NCT05633095

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

Conditions: Dementia, Mild, Cognitive Disorder Mild

Sex: All
Ages: 60 Years – 85 Years
Phase: NA
Enrollment: 20
Sponsor: Deepsonbio

Location: Korea, Republic of

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 Criteria

Inclusion Criteria:Adults aged 60 to 85Patients who meet "Probable Alzheimer's disease" and "Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV)" criteria for dementiaPatients with CDR (clinical dementia rating) from 0.5 to 1 and MMSE-II over 18Upon 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 precautionsExclusion Criteria:Patient with pathological lesions in the brain identified by MRIPatients 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 declineHistory of psychiatric disorder other than the inclusion criteria.A person with a severe history of cancer/tuberculosisA person who has or is taking psychiatric or peripheral/central nervous system drugsA person who has contact dermatitis or sensitive skin abnormalitiesPatients with a high fever of 40 degrees or higher based on eardrum body temperatureA person whose bleeding is identified within the last 3 months due to a common procedure/surgery that may affect vital signsA person who is unable to perform MRI testsPregnant womenPatient with calcification in the brain identified by CTPatient with allergic to contrast agents such as Definity or GadovistOther cases where the investigator judged that it is difficult to participate in the study;

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05633095). StuddyBuddy aggregates publicly available trial information.