跳至主要内容
临床试验/EUCTR2019-004634-41-ES
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

发起方
Institut de Recerca HSCSP

相似试验