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临床试验/NCT02964637
NCT02964637招募中不适用

Multimodal Assessment for Predicting Specific Pathological Substrate in Frontotemporal Lobar Degeneration

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年8月最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Differences between the FTLD groups via PET imaging of the brain

研究概览

简要总结

To establish diagnostic tools to make an accurate clinical and pathological diagnosis of patients with clinical FTLD syndromes

详细描述

The goal of this study is to determine the best diagnostic test for diagnosing frontotemporal lobar degeneration. To accomplish this, the current study will evaluate different tests: brain imaging, skin biopsy, body fluid samples (blood and cerebrospinal fluid), thinking abilities, everyday functioning, and brain autopsy. The study team hopes that this information can be used to guide diagnosis and further understanding of mechanism of disease in Frontotemporal Lobar Degeneration and possibly treatment in the future.

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
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participant must have a reliable study partner who can provide an independent evaluation of functioning.
  • Able to read, understand and speak English for neuropsychological testing.
  • All subjects must meet one of these diagnostic criteria (A) probable behavioral variant FTD, (B) MRI-supported non-fluent variant PPA; (C) MRI-supported semantic variant PPA and [18F]T807 negative (D) probable CBS: using current criteria for CBS(27); (E) PSP: inclusion criteria for PSP are based upon the National Institute of Neurological Disorders and Stroke Society of Progressive Supranuclear Palsy (NINDS-SPSP) (F) FTD-MND
  • Control subjects must have a normal neurological exam, a CDR sum of boxes = 0, and MMSE score equal to or greater than 28

排除标准

  • Patients with clinical, imaging or CSF A beta/ tau profile consistent with AD
  • History of traumatic brain injury, brain tumors, stroke or other neurological or psychiatric disorders that can explain symptoms will be excluded.
  • Premenopausal women will be asked to consent to a pregnancy test prior to each scan as pregnant women will be excluded from study because of potential harm to fetus from PET study.
  • Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body.

结局指标

主要结局

Differences between the FTLD groups via PET imaging of the brain

时间窗: One time visit through study completion of 5 years

Differences in ligand uptake

Structural and Functional Diffferences between the FTLD groups via MRI of the brain

时间窗: One time visit through study completion of 5 years

Differences in brain volumes and resting state functional connectivity

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carmela Tartaglia

Principal Investigator

University Health Network, Toronto

研究点 (1)

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