NCT05633095招募中不适用
A Prospective Pilot Study to Evaluate Efficacy and Safety of Medical Device-Neuclare in Patient With Mild Cognitive Disorder and Early Dementia
Deepsonbio4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年10月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Change of Trail Making Test Black & White Score : From Baseline to Week 5
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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;
结局指标
主要结局
Change of Trail Making Test Black & White Score : From Baseline to Week 5
时间窗: 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
次要结局
- 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 Aβ oligomer density measured by MDS-OAβ test result : From Baseline to Week 5(Week 5)
- Change of MMSE-II Score : From Baseline to Week 5(Week 5)
- Change of glucose metabolic rate in brain measured by FDG PET-CT : From Baseline to Week 5(Week 5)
- Change of Quality of life-AD 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)
研究者
研究点 (4)
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