CClinicalTrials.gg
Status unknownNCT05633095Updated Mar 24, 2023

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

An interventional study of Neuclare in Dementia, Mild and Cognitive Disorder Mild, sponsored by Deepsonbio. Status unknown at 2 sites in Korea, Republic of. Open to participants aged 55 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-03-24.

Sponsored by Deepsonbio · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
55 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Dementia, Mild
  • Cognitive Disorder Mild
03

In context

Dementia

2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.

This study's planned enrollment of 20 is below the median of 83 across 1,629 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

Deepsonbio is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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;
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Treatment group

    The patient with mild cognitive disorder and early dementia who will be treated with the medical device-Neuclare

    Device: Neuclare

Interventions

  • DeviceNeuclare

    It is used to stimulate the brain for a certain period of time to improve cognitive impairment in patients with cognitive disorder. In this clinical trial, it is used for patients with mild cognitive disorder and demincia symptoms.

06

What researchers measure

Primary outcomes

  1. Change of Trail Making Test Black & White Score : From Baseline to 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

    Time frame: Week 5

Secondary outcomes

  1. Change of Attention Questionnaire Scale : From Baseline to Week 5

    Compare with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as evaluated by Attention Questionnaire Scale

    Time frame: Week 5

  2. Change of Neuropsychiatric Inventory Score : From Baseline to Week 5

    Compare with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as evaluated by Neuropsychiatric Inventory score

    Time frame: Week 5

  3. Change of Quality of life-AD Score : From Baseline to Week 5

    Compare with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as evaluated by Quality of life-AD Score

    Time frame: Week 5

  4. Change of MMSE-II Score : From Baseline to Week 5

    Compare with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as evaluated by MMSE-II Score

    Time frame: Week 5

  5. change of beta-amyloid deposition measured by Amyloid PET-CT : From Baseline to Week 5

    change of beta-amyloid deposition with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as measured by Amyloid PET-CT

    Time frame: Week 5

  6. Change of glucose metabolic rate in brain measured by FDG PET-CT : From Baseline to Week 5

    Compare glucose metabolic rate with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as measured by FDG PET-CT

    Time frame: Week 5

  7. Change of Aβ oligomer density measured by MDS-OAβ test result : From Baseline to Week 5

    Compare Aβ oligomer density with before and after using Neuclare for the treatment of mild cognitive disorder and early dementia as measured by MDS-OAβ test

    Time frame: Week 5

07

Study locations

2 of 2 sites recruiting
  • Hallym University Dongtan Sacred Heart Hospital
    Hwaseong-si, Gyeonggi-do 18450, Korea, Republic of
    • Seonkyu Kim · Contact · ksksbs@deepsonbio.com · +82 10-4324-5147
    • Jaeho Kim, M.D. Ph.D · Principal investigator
    Recruiting
  • Seoul National University Bundang Hospital
    Seongnam-si, Gyeonggi-do 13620, Korea, Republic of
    • Seonkyu Kim · Contact · ksksbs@deepsonbio.com · +82-10-4324-5147
    • SangYun Kim, M.D. Ph.D · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05633095
Lead sponsor
Deepsonbio
Responsible party
Sponsor
First posted
Dec 1, 2022
Start date
Oct 7, 2022
Primary completion
Jul 31, 2023 (estimated)
Completion
Mar 30, 2024 (estimated)
Last update
Mar 24, 2023

Study contacts

Seonkyu Kim
Contact
ksksbs@deepsonbio.com
+82-10-4324-5147
SangYun Kim, M.D. ph.D
principal investigator · Seoul National University Bundang Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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