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

Deepsonbio

Status

Enrolling

Conditions

Dementia, Mild

Cognitive Disorder Mild

Treatments

Device: Neuclare

Study type

Interventional

Funder types

Industry

Identifiers

NCT05633095

Deepsonbio_Neuclare

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

55 to 90 years old

Volunteers

No 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

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;