2023-510216-39-00招募中2 期
A double-blinded, randomized, placebo-controlled, multi-center trial of Efgartigimod in autoimmune dementia (EfgaDem)
Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2025年6月17日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Cognitive impairment: MoCA: change from baseline to 53 weeks. (dichotomized version of the change of the score ≥0 or <0).
研究概览
简要总结
To investigate the efficacy of 52 weeks treatment with the FcRn inhibitor Efgartigimod in comparison to placebo regarding the cognitive impairment in patients with autoimmune dementia.
研究设计
- 分配方式
- Randomized
- 主要目的
- Double-blinded randomized placebo-controlled multi-center trial of Efgartigimod in AD
- 盲法
- Double (Carer, Analyst, Monitor, Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects ≥ 40 years of age
- •Expert diagnosis of progressive cognitive impairment or dementia for more than 3 months
- •10 < MoCA ≤ 25
- •Presence of anti-brain autoantibodies in serum and/or CSF
- •Age ≥ 40 years
- •Speaks German at a level that, as determined by the investigator, allows to understand the patient information and to reliably perform the neuropsychological assessments
- •Written consent to participate in the study
- •The patient is capable to attend study visits
- •Vaccination according to STIKO recommendations (incl. COVID-19 vaccination)
排除标准
- •Dysfunction (other than neurodegenerative or immunological) that could distort or obscure the diagnosis of dementia such as vitamin deficiency or hypothyroidism
- •HIV infection
- •Active, severe infections (e.g. sepsis and opportunistic infections)
- •History of chronically active hepatitis including active or chronic hepatitis B, acute or chronic hepatitis C
- •Clinically significant infection involving intravenous administration of antibiotics and hospitalization in the 4 weeks prior to the screening visit
- •Serious impairment of the immune system
- •Severe disease in the renal, cardiovascular or hematological system
- •Any medical condition that, in the opinion of the Investigator, might interfere with the patient’s participation in the trial or poses any added risk for the patient
- •Severe active psychiatric illness
- •Contraindications against MRI examination (e.g. wearers of pacemakers, deep brain stimulators, cerebrospinal fluid shunt valves, very large tattoos, metal splinter injuries and implants containing metal in the body)
- •Participation in any other investigational drug study or exposure to an investigational drug within 5 half-lives of the study drug at baseline
- •MRI findings (macro bleeding, malignant tumors)
- •Treatment with B-cell depleting therapy in the last 6 months
- •History of recurrent or chronic infections or with underlying diseases which may further predispose patients to serious infection
- •Sexually active male and female patients of reproductive potential (female patients/female partners of patients less than 12 months postmenopausal) who do not use highly effective contraception methods (pearl index <1) during treatment
- •Hypersensitivity to the active substance and/or pharmaceutical excipients
- •Known cytokine release syndrome after infusions
- •Pregnancy or lactation
结局指标
主要结局
Cognitive impairment: MoCA: change from baseline to 53 weeks. (dichotomized version of the change of the score ≥0 or <0).
Cognitive impairment: MoCA: change from baseline to 53 weeks. (dichotomized version of the change of the score ≥0 or <0).
次要结局
- MoCA: Evaluation of change in continuous score from baseline to week 13, 27 and 53
- Neuropsychological tests: change from baseline to week 13 and 53
- Quality of Life: change from baseline to week 13 and 53
- Activities of Daily Living: change from baseline to week 13 and 53
- Reduction of autoantibodies from baseline to week 13 and 53
- Partial normalization of further laboratory parameters from baseline to week 53
- Serum and cerebrospinal fluid analyses with cell count, cytology, protein, glucose, lactate and infection markers
研究者
Prof. Dr. Harald Prüß
Scientific
Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.
研究点 (2)
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