Dementia, MildNCT05633095
The Pilot Study of Medical Device-Neuclare for Patients With Mild Cognitive Disorder and Early Dementia
A study testing Neuclare in people with Dementia, Mild and Cognitive Disorder Mild, run by Deepsonbio at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Dementia, Mild, Cognitive Disorder Mild
- What is being tested?
- Neuclare
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 7 Oct 2022to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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;
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, 18450
Seonkyu Kim, +82 10-4324-5147, ksksbs@deepsonbio.com
Jaeho Kim, M.D. Ph.D
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Seonkyu Kim, +82-10-4324-5147, ksksbs@deepsonbio.com
SangYun Kim, M.D. Ph.D
About this study
Official title: A Prospective Pilot Study to Evaluate Efficacy and Safety of Medical Device-Neuclare in Patient With Mild Cognitive Disorder and Early Dementia
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.
- Conditions
- Dementia, Mild, Cognitive Disorder Mild
- Being tested
- Neuclare
- Medical subject headings
- Dementia, Lymphoma, Follicular, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuclareDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | The patient with mild cognitive disorder and early dementia who will be treated with the medical device-Neuclare Receives: Device: Neuclare |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 5
Secondary outcomes (7)
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
Measured: Week 5
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
Measured: Week 5
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
Measured: Week 5
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
Measured: Week 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
Measured: Week 5
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
Measured: Week 5
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
Measured: Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start7 Oct 2022
- Primary completion31 Jul 2023 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia, MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deepsonbio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SangYun Kim, M.D. ph.D, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633095
- Sponsor's protocol ID
- Deepsonbio_Neuclare
- Status last verified
- Nov 2022
- First submitted
- 21 Nov 2022
- Last updated
- 24 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Study to Evaluate Efficacy and Safety of Medical Device-Neuclare in Patient With Mild Cognitive Disorder and Early Dementia
- ClinicalTrials.gov ID
- NCT05633095
- Acronym / sponsor ID
- Deepsonbio_Neuclare
- Conditions
- Dementia, Mild, Cognitive Disorder Mild
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- DeepsonbioIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: NeuclareThe patient with mild cognitive disorder and early dementia who will be treated with the medical device-Neuclare |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuclareIt 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. | Device | Treatment group |
Primary outcome
Change of Trail Making Test Black & White Score : From Baseline to Week 5
Time frame: 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
7 secondary outcomes
Change of Attention Questionnaire Scale : From Baseline to Week 5
Time frame: Week 5
Change of Neuropsychiatric Inventory Score : From Baseline to Week 5
Time frame: Week 5
Change of Quality of life-AD Score : From Baseline to Week 5
Time frame: Week 5
Change of MMSE-II Score : From Baseline to Week 5
Time frame: Week 5
change of beta-amyloid deposition measured by Amyloid PET-CT : From Baseline to Week 5
Time frame: Week 5
Change of glucose metabolic rate in brain measured by FDG PET-CT : From Baseline to Week 5
Time frame: Week 5
Change of Aβ oligomer density measured by MDS-OAβ test result : From Baseline to Week 5
Time frame: Week 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SangYun Kim, M.D. ph.D principal investigator
Seoul National University Bundang Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuclare in people with Dementia, Mild and Cognitive Disorder Mild, run by Deepsonbio at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seonkyu Kim (+82-10-4324-5147, ksksbs@deepsonbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Trail Making Test Black & White Score : From Baseline to Week 5 (time frame: Week 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.