NCT05590442招募中不适用
Early Diagnosis and Risk Evaluation of Mild Cognitive Impairment in Diabetes
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年9月1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
- 500
- 试验地点
- 1
- 主要终点
- The rate of mild cognitive impairment occurrence
研究概览
简要总结
Development and validation of a risk model for predicting the risk of mild cognitive impairment among individuals of type 2 diabetes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes mellitus ;
- •Aged:40 -80 years ;
- •Montreal Cognitive Assessment Scale (MoCA) scores 19 - 30;
排除标准
- •Mini-mental State Examination(MMSE) scores < 24;
- •Other dementia related neurological diseases or depression, schizophrenia in the past 2 years;
- •Central nervous system diseases, including brain trauma, intracranial hemorrhage, acute cerebral infarction;
- •Severe sinusitis, nasal cavity and sinus polyps, skull base or nasopharyngeal tumors and other space occupying lesions, congenital diseases and traumatic history of nose, maxillofacial and skull base affecting olfaction;
- •Diabetic acute and chronic complications, including diabetic ketoacidosis, a hyperglycemic hyperosmolar state or severe hypoglycemic coma.
结局指标
主要结局
The rate of mild cognitive impairment occurrence
时间窗: 1 year
The rate of Montreal Cognitive Assessment(MoCA) scores less than 26 points after 1 year's follow-up.
次要结局
- Olfactory threshold test(1 day)
- Olfactory memory test(1 day)
- Montreal Cognitive Assessment (MoCA) score(1 day)
- Glycaemic control measured by blood test.(1 day)
- Physical assessments.(1 day)
研究者
研究点 (1)
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