EUCTR2019-004634-41-ES进行中(未招募)1 期
Study of the positron emission tomography (PET) tracer for tau 18F-PI-2620 in individuals with Down syndrome
Institut de Recerca HSCSP0 个研究点目标入组 80 人开始时间: 2020年6月4日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 80
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
- •Criteria of control subjects:
- •- Men and women with age> 35 years.
- •- Absence of cognitive complaints.
- •- Normal neuropsychological examination with MMSE scores between 24 and 30, absence of subjective memory complaints or objective memory deficit (measured with the Free and Cued Selective Reminding Test - FCSRT- (Grober, Buschke et al. 1988)) with a scalar score equal to or greater than 8 and a clinical dementia rating scale (CDR) score of 0 (Morris 1993).
- •- Understand and accept the study procedures and sign an informed consent (guardian and / or patient).
- •Inclusion criteria for participants with DS:
- •- Men and women diagnosed with DS> 35 years.
- •- Intellectual quotient> 34 (equivalent to mild and moderate mental retardation according to ICD-10 criteria).
- •- Existence of reliable informant.
- •- Participants / legal guardians who sign the IC for inclusion in the study.
- •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 80
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Not meeting the inclusion criteria.
- •- Severe depression (Geriatric scale score Scale depression> 20).
- •- History of stroke, Hachinski score> 4 or previous neurological or psychiatric illness.
- •- Confirmed pregnancy or possibility of pregnancy at the time of inclusion in the study.
研究者
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