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
1 other identifier
interventional
20
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 7, 2022
CompletedFirst Submitted
Initial submission to the registry
November 21, 2022
CompletedFirst Posted
Study publicly available on registry
December 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2024
CompletedMarch 24, 2023
November 1, 2022
10 months
November 21, 2022
March 22, 2023
Conditions
Outcome Measures
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
Week 5
Secondary Outcomes (7)
Change of Attention Questionnaire Scale : From Baseline to Week 5
Week 5
Change of Neuropsychiatric Inventory Score : From Baseline to Week 5
Week 5
Change of Quality of life-AD Score : From Baseline to Week 5
Week 5
Change of MMSE-II Score : From Baseline to Week 5
Week 5
change of beta-amyloid deposition measured by Amyloid PET-CT : From Baseline to Week 5
Week 5
- +2 more secondary outcomes
Study Arms (1)
Treatment group
EXPERIMENTALThe patient with mild cognitive disorder and early dementia who will be treated with the medical device-Neuclare
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Deepsonbiolead
Study Sites (2)
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, 18450, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
SangYun Kim, M.D. ph.D
Seoul National University Bundang Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2022
First Posted
December 1, 2022
Study Start
October 7, 2022
Primary Completion
July 31, 2023
Study Completion
March 30, 2024
Last Updated
March 24, 2023
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share