The total number of inclusion in this study is 170 subjects
Conditions
Interventions
Trade Name: Florbetapir F-18
Product Name: florbetapir (18F) solution for injection
Product Code: 18F-AV-45
Pharmaceutical Form: Solution for injection
INN or Proposed INN: florbetapir (18F)
CAS Numbe
Sponsors
VU University Medical Center (VUmc)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written informed consent; - weight >50 kg; - Mini Mental State Examination score = 18. 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 140 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Patients who 1. Have a current clinically significant psychiatric condition that neurologists/geriatricians feel would preclude the ability to have a research PET scan; 2. Have Acquired Immune Deficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV); 3. Are women of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. Women of childbearing potential must not be pregnant (negative urine ß-hCG at the time of screening and negative urine ß-hCG on the day of imaging) or breast feeding at screening. Women must avoid becoming pregnant, and must agree to refrain from sexual activity or to use reliable contraceptive methods such as prescribed birth control or IUD for 24 hours following administration of florbetapir (18F); 4. Have a relevant history of severe drug allergy or hypersensitivity (relevant severe drug allergies should be determined by the Principal Investigator or Co-Principal Investigator, and any questions about a subject’s eligibility can be directed to Avid Radiopharmaceuticals Inc. If a subject has a history of severe drug allergies, it may be dangerous for them to participate in a study with a novel compound); 5. Have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, ?-secretase or ?-secretase inhibitor) unless it can be documented that the subject received only placebo during the course of the trial; 6. Have donated blood within 3 months prior to the florbetapir (18F) PET scan day; 7. Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days; 8. Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Careful tracer kinetic modelling of specific binding is required especially for assessment of changes in amyloid binding over time or when using pharmacologic interventions designed to lower amyloid binding. In addition, its [18F]-label with a half-life of 110 minutes will enable use in hospitals without an on-site cyclotron, greatly enhancing its clinical applicability. The present study is designed to evaluate tracer kinetics of [18F]AV-45 and to investigate its clinical diangostic value. ;Secondary Objective: Not applicable;Primary end point(s): This study is divided in two sub-studies: a kinetic modelling study and a clinical diagnostic study. The main outcome measures of the kinetic modelling study are the identification the most suitable tracer kinetic method for quantification of [18F]AV-45 and the determination of a validated (simplified) tracer kinetic model for [18F]AV-45 analysis which will be used in the clinical diagnostic study. The outcome measure of the clinical diagnostic study is the diagnostic value of (both visual and quantitative rated) [18F]AV-45 PET scans in a memory clinic patient cohort. ;Timepoint(s) of evaluation of this end point: First, the kinetic modelling substudy will be performed in order to evaluate the most suitable tracer kinetic method for quantification and identify the most suitable kinetic model. After, patient of the clinical diagnostic substudy will be included. The determined kinetic model will be applied on PET data of these memory clinic patient population. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary study parameters are the concordance of [18F]AV-45 PET with MRI markers (MTA) and with CSF markers (Aß 1-42, total tau and p-tau 181) will be assessed by binary rating (e.g. ‘normal’ or ‘abnormal’) for each of these measures. Furthermore, at baseline dementia severity and neuropsychological measures will be obtained to allow analysis of associations with continuous measures of cognitive impairment to determine the prognostic value of [18F]AV-45 PET.;Timepoint(s) of evaluation of this end point: Evaluation will be performed after the last patient's last visit in the clinical diagnositc study. | — |
Countries
Netherlands
Contacts
Public ContactAlzheimer center
VU University Medical Center (VUmc)
Outcome results
None listed