NCT05764538招募中2 期
DAOIB for the Treatment of Cognitive Impairment Induced by COVID-19 -An Open Trial
Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年2月27日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24
研究概览
简要总结
This is a 24-week open trial. We will enroll long-COVID patients with cognitive impairments. All patients will receive DAOIB for 24 weeks. We will assess the patients every 8 weeks during the treatment period (weeks 0, 8, 16, and 24). We hypothesize that DAOIB treatment will be beneficial in improving the cognitive function, mood symptoms, global functioning and quality of life in long-COVID patients with cognitive impairments.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •"post-COVID-19 condition" defined by WHO (symptoms present at three months after SARS-CoV-2 infection and last for at least 2 months which cannot be explained by an alternative diagnosis)(Cabrera Martimbianco, Pacheco et al. 2021) and COVID-induced cognitive impairments
- •physically healthy and have all laboratory assessments (including urine/blood routine, biochemical tests, and electrocardiograph) within normal limits
- •have sufficient education to communicate effectively and are capable of completing the assessments of the study
排除标准
- •history of significant cerebrovascular disease
- •Hachinski Ischemic Score > 4
- •major neurological, psychiatric or medical conditions other than long COVID-induced cognitive impairments
- •memantine use (memantine is an NMDAR partial antagonist)
- •substance (including alcohol) abuse or dependence
- •delusion, hallucination or delirium symptoms
- •severe visual or hearing loss
- •inability to follow the protocol
研究组 & 干预措施
DAOIB
Experimental
干预措施: DAOIB (Drug)
结局指标
主要结局
Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24
时间窗: week 0, 8, 16, 24
Alzheimer's disease assessment scale-cognitive subscale scores range from 0 (best) to 70 (worst)
次要结局
- Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24(week 8, 16, 24)
- Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 8, 16 and 24(week 0, 8, 16, 24)
- Change from baseline in Quality of life score at week 8, 16 and 24(week 0, 8, 16, 24)
- Change from baseline of Perceived Stress Scale(week 0, 8, 16, 24)
- Change from baseline in the score of a battery of additional cognitive tests(week 0, 8, 16, 24)
- Change from baseline of 17-item Hamilton Rating Scale for Depression(week 0, 8, 16, 24)
- Change from baseline of Hamilton Anxiety Rating Scale(week 0, 8, 16, 24)
研究者
研究点 (1)
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