Tau-imaging in tauopathies; Alzheimer’s disease and non-AD dementias - TITA

VU University Medical Center0 个研究点开始时间: 2016年1月20日最近更新: 2017年10月2日

适应症

试验速览

暂无简介。

•In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•-At least 50 years of age
•-Subjects must, in the opinion of the principal investigator/attending neurologist, be able to tolerate the [18F]AV1451 PET scan procedures and be competent to make a well informed decision to participate in this study.
•Additional inclusion criteria per diagnostic group:
•For probable AD dementia patients;
•-A diagnosis of probable AD with at least intermediate likelihood according to recently proposed NIA-AA criteria. This will be determined using PET and/or CSF evidence of Aß deposition.
•For MCI due to AD” patients;
•-Patients must meet clinical criteria for MCI, and;
•present with positive Aß biomarkers on PET and/or CSF.For patients with a dementia syndrome likely induced by tauopathy;
•For DLB patients;
•-Patients must be included in the DEvELOP (protocol number 15/548)
•-Subjects must, in the opinion of the principal investigator/attending neurologist, be able to tolerate the [18F] FDG PET scan procedures
•For controls;
•-No objective evidence of cognitive impairment as assessed by a multidisciplinary specialist team;
•-normal MRI;
•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 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 160

•No MRI available or possible
•Abnormalities on MRI which may interfere with PET image assessment:
•Is or may become pregnant in the 90 days after the PET scan
•Relevant history of drug allergy or hypersensitivity
•Has ever recieved a tau and/or amyloid-beta targetting agent
•Has been injected with a previously administered radiopharmaceutical within 6 terminal half-lives OR the total yearly radiation exposure exceeds 10 mSv;
•Has current clinically significant cardiovascular disease or clinically significant abnormalities on screening ECG (e.g. QTc > 450 msec)
•Has a history of moderate or severe traumatic brain injury (TBI).

发起方

VU University Medical Center