Dementia inducing Alzheimer's disease, Frontotemporal dementia (FTD) and Lewy Body Dementia (DLB) MedDRA version: 20.0 Level: PT Classification code 10012271 Term: Dementia Alzheimer's type System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: LLT Classification code 10057095 Term: Diffuse Lewy body disease System Organ Class: 100000072901 MedDRA version: 20.0 Level: PT Classification code 10068968 Term: Frontotemporal dementia System Organ Class: 10029205 - Ner
Conditions
Interventions
Product Name: 18F-AV-1451
Pharmaceutical Form: Solution for injection
INN or Proposed INN: not applicable
CAS Number: 152201-90-6
Current Sponsor code: 18F-Av-1451
Other descriptive name: T807
Concent
Sponsors
VU University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Neuropsychological performance (over time); - Gray matter volumes on MRI - CSF protein levels (tau, ptau and Aß42); - Aß-PET tracer binding. - FDG-PET binding;Timepoint(s) of evaluation of this end point: - Neuropsychological performance (over time) at baseline and follow-up after one year - Gray matter volumes on MRI taken as part of clinical dementia screening. - CSF protein levels (tau, ptau and Aß42) obtained by a lumbar punction performed as part of clinical dementia screening - 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 | — |
Countries
Netherlands
Contacts
Public ContactDept. Radiology & Nuclear Medicine
VU University Medical Center
Outcome results
None listed