NCT06234436Unknown早期 1 期
Plasma Dilution and Infusion to Improve Cognition in Mild Cognitive Impairment (MCI)
Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年12月7日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Adverse events
研究概览
简要总结
In the ADDITION-MCI project, patients with a diagnosis of mild cognitive impairment probably caused by Alzheimer's disease will receive plasma exchange.
详细描述
Repeated plasma exchanges will be conducted, and cognitive outcomes will be measured before and after the intervention.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Alzheimer's Disease
- •MoCA score < 27 and >17
- •Able to give informed consent as judged by the doctor setting the AD diagnosis and study doctor.
- •At least one biomarker of the AT(N)-classification system supporting the diagnosis
- •Expected to live more than five years at inclusion by the study doctor.
排除标准
- •Known IgA deficiency
- •Known severe protein S depletion
- •Previous severe allergic reaction after transfusion of a blood product
- •Known heart failure
- •Known liver failure
- •Known kidney failure
- •Previous cancer <10 years.
- •Not deemed able to participate by the study staff
- •Other severe chronic diseases, interfering with the TPE-procedure
- •Ongoing infections
- •Other unresolved medical conditions
- •Known coagulopathies
- •Fulfilling ICD-10 criteria for dementia at baseline, as evaluated by the evaluating physician.
- •Peripheral veins not expected to be suitable for repeated venous access procedures.
结局指标
主要结局
Adverse events
时间窗: Up to 4 years
Safety of the intervention in the patient group measured as number and severity of adverse events. This will be evaluated as the number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
次要结局
- Burden of participation questionnaire sum score(2 months)
- Change in IL10 from baseline(6 months)
- Change in IL6 from baseline(6 months)
- Change in Montreal Cognitive Assessment (MoCA) Test for Dementia(48 months)
- Change in grip strength from baseline(48 months)
- Change in the CERAD 10-word test performance from baseline(48 months)
- Change in the trail making test A or B (as appropriate) time from baseline(48 months)
- Change in 4 meter walk test from baseline(48 months)
- Change in IQCODE from baseline(48 months)
研究者
Arne Vasli Lund Søraas
PI
Oslo University Hospital
研究点 (2)
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