2024-513963-22-00招募中4 期
Cognitive function after liver transplantation comparing Tacrolimus formulations
Universitaetsklinikum Schleswig-Holstein AöR5 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年10月24日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 5
- 主要终点
- Change in subjective impression of QoL concerning attention/concentration and memory between Screening and visit 3 (6 months) using the FEDA (self-report questionnaire on attention and memory)
研究概览
简要总结
To determine whether once-daily formulation of Tacrolimus (Envarsus ®) improves subjective impression of attention and memory performance compared to twice-daily formulation of Tacrolimus
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Age 20 to 75 years
- •After 12 months post liver transplantation
- •Immunosuppression with a twice daily formulation of Tacrolimus
- •Application of the same active Tacrolimus twice daily formulation ≥3 months
- •At least mild cognitive impairment
排除标准
- •Dialysis treatment during the previous 30 days
- •Deafness and/or blindness
- •Pregnancy/breastfeeding mothers
- •Current participation in another study
- •Every other aspect that, in the eye of investigator, makes the patient unable to comply with study procedures
结局指标
主要结局
Change in subjective impression of QoL concerning attention/concentration and memory between Screening and visit 3 (6 months) using the FEDA (self-report questionnaire on attention and memory)
Change in subjective impression of QoL concerning attention/concentration and memory between Screening and visit 3 (6 months) using the FEDA (self-report questionnaire on attention and memory)
次要结局
- Cognitive function is assessed using (I) the Trail Making Test – TMT (time criterion), (II) Adaptive Digit Ordering Test – DOT-A (number of correctly sorted digits), (III) Digit Symbol Test – DST (number of correctly sorted items), (IV) Regensburg Stream of Speech Test – RWT (number of correct items), (V) Victoria Stroop Test – VST (time criterion)
- Quality of life (QoL) is measured using the SF36 (summary score). QoL will be performed during Screening, after 6 and after 12 months.
- Everyday executive function is measured by BAFQ (assessment by close relative/partner or care provider). BAFQ will be performed during Screening, after 6 and after 12 months.
- All (serious) adverse events including clinically significant laboratory parameters and relevant liver and kidney functioning parameters are documented at each visit after baseline.
研究者
Felix Braun
Scientific
Universitaetsklinikum Schleswig-Holstein AöR
研究点 (5)
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