Imaging of tau in patients with dementia

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To test the novel PET-tracer 18F-AV-1451 for tau pathology as a diagnostic and prognostic marker in tauopathies;Secondary Objective: To examine the (regional) binding of 18F-AV-1451 across tauopathies, and the relationships between tracer binding, neurodegeneration and symptoms. <br>To explore the predictive value of [18F]AV1451 binding for change over time in neuropsychological performance.;Primary end point(s): Quantification and distribution of 18F-AV-1451 specific binding.;Timepoint(s) of evaluation of this end point: Continious PET scan from 0-60 and 80-130 minutes post injection at baseline

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Neuropsychological performance (over time);<br>-Gray matter volumes on MRI<br>-CSF protein levels (tau, ptau and Aß42);<br>-Aß-PET tracer binding. <br>- FDG-PET binding;Timepoint(s) of evaluation of this end point: -Neuropsychological performance (over time) at baseline and follow-up after one year<br>-Gray matter volumes on MRI taken as part of clinical dementia screening. <br>-CSF protein levels (tau, ptau and Aß42) obtained by a lumbar punction performed as part of clinical dementia screening<br>-Amyloid beta-PET tracer binding obtained (where applicable) from previously performed amyloid-beta PET scans with 18F-Florbetapir, 18F-Florbetaben or 11C-Pittsburgh compound B<br><br>