Clinical trial NCT05633095: The Pilot Study of Medical Device-Neuclare for Patients With Mild Cognitive Disorder and Early Dementia
Official title: A Prospective Pilot Study to Evaluate Efficacy and Safety of Medical Device-Neuclare in Patient With Mild Cognitive Disorder and Early Dementia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dementia, Mild
Cognitive Disorder Mild
Lead sponsor: Deepsonbio
Sponsor class: INDUSTRY
First posted: 2022-12-01
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Change of Trail Making Test Black & White Score : From Baseline to Week 5
timeFrame: Week 5
Secondary outcomes:
measure: Change of Attention Questionnaire Scale : From Baseline to Week 5
timeFrame: Week 5
measure: Change of Neuropsychiatric Inventory Score : From Baseline to Week 5
timeFrame: Week 5
measure: Change of Quality of life-AD Score : From Baseline to Week 5
timeFrame: Week 5
measure: Change of MMSE-II Score : From Baseline to Week 5
timeFrame: Week 5
measure: change of beta-amyloid deposition measured by Amyloid PET-CT : From Baseline to Week 5
timeFrame: Week 5
measure: Change of glucose metabolic rate in brain measured by FDG PET-CT : From Baseline to Week 5
timeFrame: Week 5
measure: Change of Aβ oligomer density measured by MDS-OAβ test result : From Baseline to Week 5
timeFrame: Week 5
Other outcomes:
Locations:
city: Hwaseong-si
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: SangYun Kim, M.D. ph.D
role: PRINCIPAL_INVESTIGATOR
References: