KCT0009133
招募中
未知
A multicenter, prospective, comparative, randomized, independent rater-blind, superiority, pivotal clinical trial to compare the safety and efficacy of the Cognitive therapy software ‘SUPERBRAIN DEX’ for improving cognitive function with a control group for patients with mild cognitive impairment
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- Mental and behavioural disorders
- 发起方
- Hanyang University Guri Hospital
- 入组人数
- 126
- 状态
- 招募中
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. adults between 50 and 85
- •2\. Those who meet all of the National Institute on Aging\-Alzheimer's Association (NIA\-AA) key clinical criteria below that may suspect mild cognitive impairment caused by Alzheimer's disease as of the screening date
- •? Concern of the subject or guardian about the deterioration of cognitive function compared to before
- •? More than one cognitive impairment
- •? Maintaining the independence of overall daily life functions
- •? It's not dementia
- •3\. In at least one of the following neuropsychological tests conducted within one year of the screening date, the delayed recall score in the memory area was 'average \-1' according to the standard score table corrected for education level and age.
- •? Seoul Neuropsychological Screening Battery 2nd edition (SNSB\-II)
- •? Korean version of Consortium to Establish a Registry for Alzheimer’s Disease (CERAD\-K)
- •? Literacy Independent Cognitive Assessment (LICA)
排除标准
- •1\. Those diagnosed with dementia (including Alzheimer's disease, vascular dementia, infections of the central nervous system (e.g., Human Immunodeficiency Virus (HIV), syphilis, etc.), Creutzfeld\-Jacob disease (Creutzfeld\-Jacob disease), Pick disease, Huntington's disease, Parkinson's disease, etc.) as of the screening date
- •2\. Those who have a history of diagnosing significant neurological diseases affecting cognitive function within one year of the screening date (e.g., stroke, multiple sclerosis, severe head trauma with loss of consciousness, normal cerebral hydrocephalus, epilepsy, brain tumors, cerebral infarction, spinal cord infarction or central nervous system infection)
- •3\. Based on the screening date, major depressive disorder, bipolar disorder, schizophrenia, A person diagnosed with a serious mental illness such as drug addiction and alcoholism
- •4\. Laboratory and/or vital signs tests as of the date of screening, any of the following
- •? Those diagnosed with infectious or metabolic diseases that may cause cognitive decline in the subject (e.g., hypothyroidism, vitamin B12 deficiency, folate deficiency, neurotoxin, HIV)
- •? Those with liver dysfunction (AST, ALT \= 3x upper limit of normal range) and/or renal dysfunction (serum creatinine \= 2x upper limit of normal range)
- •? Those with uncontrolled hypertension (SBP\>180 mmHg) and/or diabetes (HbA1c\>11%)
- •5\. Those who have severe or unstable cardiovascular disease (e.g., myocardial infarction, unstable angina, class III or IV heart failure by classification of the New York Heart Association (NYHA) within 24 weeks of the screening date)
- •6\. Where the tester determines that he/she has a medical condition that may interfere with the completion of the clinical trial due to a serious or unstable physical condition (e.g., a history of malignant tumors within five years of the screening date (e.g., basal cell cancer and squamous cell carcinoma of the skin considered to have been completely resected and cured, cervical intraepithelial carcinoma, non\-transparent prostate cancer, acute and severe asthma, active peptic ulcers, etc.)
- •7\. If you can't walk, A person who can move using walking aids (e.g. walkers, canes, wheelchairs, etc.)
结局指标
主要结局
未指定
相似试验
尚未招募
4 期
A comparative, multicenter, prospective, randomized study to evaluate efficacy, safety and prevention of relapse with Elovera AD emollient vs plain emollient in mild to moderate atopic dermatitisHealth Condition 1: L209- Atopic dermatitis, unspecifiedCTRI/2023/03/050333Glenmark Pharmaceuticals Limited
已完成
2 期
Clinical study on AP/VJT/SBO Ayurvedic Hair Oil in femalesHealth Condition 1: L658- Other specified nonscarring hair lossCTRI/2022/05/042393AYURVED PRATISTHA
尚未招募
不适用
A prospective trial to verify the recovery of upper extremity motor function by applying repetitive transcranial magnetic stimulation to those who need Upper-limb Rehabilitation treatment for subcortical and brain stem stroke(ischemic)KCT0007808Remed88
尚未招募
不适用
A Multi-center, Prospective, Randomized Comparison of Pulmonary Vein Isolation Techniques in Patients with Paroxysmal Atrial FibrillatioDiseases of the circulatory systemKCT0000329Asan Medical Center100
进行中（未招募）
3 期
A clinical research to study the safety, efficacy and immunogenicity of test pertuzumab in metastatic breast cancer patients.Health Condition 1: C50-C50- Malignant neoplasms of breastCTRI/2023/05/052997Enzene Biosciences Limited