Natural History of Amyloid Deposition in Adults With Down Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Amyloid deposition
研究概览
简要总结
The primary objective of this study is to assess the presence of amyloid in non-demented/functionally stable adults with DS as a function of age, dividing the sample into amyloid-positive and amyloid-negative groups. We will also obtain baseline cognitive measures across a range of areas that are often affected by AD.
详细描述
Specific Aim 1: To assess and compare amyloid deposition (with PiB PET) in non-demented/functionally stable adults with DS across three age cohorts (30-39, 40-49, and >50 years of age).
Primary Hypothesis 1: At initial assessment, there will be a significantly higher prevalence of amyloid-positive (PiB+) subjects in each succeeding age cohort.
In addition, we will test the following secondary hypothesis:
Secondary Aim 1: To compare the presence or absence of the apolipoprotein-E4 allele to the retention of PiB in various brain areas of the DS subjects.
Secondary Hypothesis 1: At baseline, subjects who carry at least one Apolipoprotein-E4 (ApoE4) allele will show a higher prevalence of being PiB+.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant IQ at least 47 (based upon Stanford-Binet V Abbrev. Test Battery)
- •Participant at least 30 years of age
- •DSDS score indicating participant is asymptomatic for AD
- •Reliable caregiver who is capable of providing correct information about the participant's clinical symptoms and history
- •Agreement of caregiver and clinician that participant is able to cooperate with the protocol tasks
- •Participant has provided assent (or consent) and/or parent/caregiver has provided informed consent
排除标准
- •Participant is non-verbal or has extremely limited language skills
- •Score within the "symptomatic" range on the DSDS
- •Any significant disease or unstable medical condition that could affect neuropsychological testing
- •Any problems with vision or hearing that could affect neuropsychological testing
- •Participants in whom MRI is contraindicated
- •Claustrophobia or prior failed experiences of completing MRI scans or blood draws
- •Participant is pregnant or breast feeding
- •History or other evidence of severe illness or other condition that would make the participant, in the opinion of the investigator, unsuitable for the study?
结局指标
主要结局
Amyloid deposition
时间窗: every 36 months for 9 years
Obtained via PiB PET scan
次要结局
未报告次要终点
研究者
Benjamin L Handen, PhD, BCBA-D
Principal Investigator
University of Pittsburgh