KCT0009453招募中Unknown
A randomized, double-blind, placebo-controlled to evaluate functionality and safety of KL-P301 in adult with mild cognitive impairment
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 60(Year) 至 o Limit(—)
- 性别
- All
入选标准
- •1. Adults aged 60 years or older at the time of screening
- •2. Those who can take oral medication
- •3. A person who does not have severe hearing, vision, or language impairment that affects the performance and completion of tests such as neuropsychological tests
- •4. Screening Test Those who do not have alcoholism or other substance abuse status, history of stroke, and evidence of central nervous system disease or damage.
- •5. A person who agreed to participate in this human application test and filled out the written consent form (Informed Consent Form) before the human application test started
- •6. Those with cognitive function resistance symptoms confirmed at the baseline visit (MMSE-standardized score of 27 points or less)
排除标准
- •1. Convulsive (epilepsy), acute brain disease, depressive disorder, bipolar disorder, schizophrenia drug use at the time of screening
- •2. Those who are taking antibiotics at the time of screening or who are expected to take antibiotics during the human application test period
- •3. A person who has had food poisoning symptoms within four months at the time of screening or at the time of screening
- •4. Those who are taking immunosuppressants (Imuran Tab., Cellcept, Genapax Inc.) at the time of screening or who are expected to take them during the human application test period
- •5. Those who are concerned about lowered immunity under the judgment of the tester during screening
- •6. Those who are taking mental health-related (depression, alcoholism) drugs for a long time at the time of screening
- •7. A person who was diagnosed with a disability (blindness in one eye, hearing loss in one ear) at the time of screening
- •8. Subjects with a history of loss of consciousness due to severe head trauma at the time of screening
- •9. Cancer patients less than three years after cancer treatment before screening
- •10. Patients who received metal implants at the time of screening
- •11. Those who have difficulty stopping taking other probiotics products during screening or those who are expected to take them during the human application test
- •12. Those who have difficulty stopping taking other brain nutrients and treatment products being taken during screening or those who are expected to take them during the human application test
- •13. Those who are sensitive or allergic to the food ingredients for this human application test (Lactobacillus brevis KL251, Lactobacillus fermentum KL271, Bifidobacterium lactis KL101 complex)
- •14. Those who have participated in other interventional clinical trials (including human trials) within three months of screening or plan to participate in other interventional clinical trials (including human trials) after the start of this human trial
- •15. Those who are judged by the tester to be unsuitable for participation for other reasons
研究者
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