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

Recruiting
55 - 90 years of age
Both
Phase N/A

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Overview

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

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;

Study details

Dementia, Mild, Cognitive Disorder Mild

NCT05633095

Deepsonbio

25 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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