DRKS00007966招募中不适用
DZNE – Longitudinal Cognitive Impairment and Dementia Study - DELCODE
Deutsches Zentrum für Neurodegenerative Erkrankungen e. V. (DZNE)0 个研究点目标入组 1,000 人开始时间: 2015年5月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 60 Years 至 90 Years（—）
- 性别
- All
入选标准
- •General inclusion criteria:
- •informed consent, incl. informed consent for lumbar puncture
- •presence of an informant, who is willing to provide information on the participant throughout the study
- •presence of an informant, who is not participating in the study and willing to provide information on the healthy control throughout the study
- •fluent German language abilities
- •age >/= 60 years
- •Inclusion criteria for respective groups of interest:
- •SCD Subjects:
- •score in the normal range (1.5 SD) of any of the CERAD+ tests at initial clinical assessment prior to study participation in the memory clinic
- •patient’s report of cognitive (e.g. memory) decline, about which (s)he expresses concerns (time of onset between the last 6 months and 5 years)
- •Siblings of patients with AD dementia:
- •presence of first degree sibling/ siblings with AD dementia, diagnosed in an expert setting (memory clinic)
- •score in the normal range of cognitive assessments at the baseline visit according to 2.2.2.4.
- •MCI Subjects:
- •perform 1.5 SD below the normal range in the delayed recall trial of the CERAD-wordlist at initial clinical assessment prior to study participation in the memory clinic
- •subjective cognitive decline by the patient can be present or not
- •either the subject or an informant or a clinician has to report a decline in cognitive function causing concerns.
- •the subjects must not fulfill dementia criteria.
- •AD Subjects:
- •must fulfill the clinical NINDCS/ADRDA criteria of probable AD (McKhann et al., 2011)
- •Healthy Controls or 3. Person, who provides information on the particitpantl throughout the study:
- •must negate subjective cognitive decline with concerns
- •must perform in the normal range of cognitive assessments at the baseline visit according to 2.2.2.4.
- •must not have a known first degree relative with dementia (parents > 75y of age or older without dementia)
排除标准
- •lack of capability to give informed consent
- •any condition that clearly interferes with participation in the study
- •any condition that interferes with the clinical or neuropsychological study procedures
- •sensory impairment that prevents or significantly interferes with neuropsychological testing
- •contraindication for both MRI and lumbar puncture
- •severe or unstable medical condition
- •current major depressive episode
- •psychotic disorder, bipolar disorder, substance abuse at present or in the past
- •neurodegenerative disorder other than AD
- •vascular dementia
- •history of stroke with residual symptoms
- •clinical significant abnormalities in Vit. B12 or TSH (not applicable for controls and relatives)
- •current or past unstable malignant disease with a reduced life expectancy (< 2 years)
- •chronic use of psychoactive drugs with sedative or anticholinergic effects
- •use of antidementia drugs in SCD, healthy siblings, MCI (Ginkgo is permitted) and in control subjects
- •investigational agents for treatment of dementia or cognitive impairment 4 weeks prior to study entry. Participation in a study using investigational medicinal products will lead to exclusion.
研究者
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