EUCTR2008-000453-35-DE进行中（未招募）不适用
Open-label phase IIa pilot study exploring safety and potential efficacy of recombinant human erythropoietin in early mild Alzheimer Dementia and therapy-refractory Major Depression (EPO-AD”) - EPO-AD
Max-Planck-Institute of Experimental Medicine0 个研究点目标入组 20 人开始时间: 2008年2月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •For patients with Alzeimer's Dementia:
- •- Diagnosis of a dementia of the Alzheimer’s Type (DSM-IV)
- •with an initial MMST score 20-26
- •- Age >40 to 70 years
- •- Close relative(s) available
- •For patients with Major Depression:
- •- Diagnosis of recurrent Major Depression (DSM-IV) with an initial HAMD score = 18
- •- Age >18 to 70 years
- •- no or inadequate response to two or more adequate trials of different classes of
- •conventional antidepressants, each tried for at least 2-3 months (i.e. therapy-
- •refractory MD)
- •General eligibility criteria for both patient groups:
- •- Both genders
- •- Outpatients
- •- Written informed consent, full contractual capability, authorization of release and
- •use of protected health information
- •- Stable medication for at least 4 weeks prior to inclusion and during follow-up
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Diagnosis of dementia due to (other) medical conditions
- •(in patients with Major Depression: previous diagnosis of any dementia)
- •- Diagnosis of psychotic, bipolar or post-traumatic stress disorders
- •- Dependence on or abuse of drugs (including benzodiazepines and alcohol)
- •- Acute suicidal tendencies
- •- Diagnosis of a neurological or other severe disease (e.g. myeloproliferative
- •disorder, malignancies, polycythemia)
- •- Renal failure (i.e. dialysis-dependent)
- •- Prior EPO treatment
- •- Major surgery within 4 weeks prior to inclusion
- •- Increased thrombembolic risk
- •- Continuous medication of sex hormones/contraceptives
- •- Initial hematocrit >50% (males) or >48% (females)
- •- Untreated or not sufficiently treated arterial hypertension
- •- MRI contraindications
- •- Known allergy or antibodies against erythropoietin
研究者
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