Alzheimer's Disease (AD) MedDRA version: 18.1 Level: PT Classification code 10012271 Term: Dementia Alzheimer's type System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.1 Level: HLT Classification code 10001897 Term: Alzheimer's disease (incl subtypes) System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: 18F-AV-1451
Pharmaceutical Form: Solution for injection
INN or Proposed INN: not applicable
CAS Number: 152201-90-6
Curren
Sponsors
VU University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A healthy control subject must meet all of the following criteria: 1. At least 50 years of age; 2. Have no evidence of cognitive impairment as indicated by a cognitive neurologist; 3. Subjects, who in the opinion of the principal investigator, can tolerate the [18F]AV1451 PET scan procedures. Probable AD subjects must meet the following inclusion criteria: 1. At least 50 years of age; 2. Have a clinical diagnosis of probable AD (McKhann, 2011) and are part of the Amsterdam Dementia Cohort (Flier et al. 2014); 3. Have a Mini Mental State Examination (MMSE) of 18 or higher; 4. Subjects, who in the opinion of the principal investigator, can tolerate the [18F]AV-1451 PET scan and blood sampling procedures. 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 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study if he or she: 1. Has contra indications for MRI scanning and therefore can not receive brain MRI 2. Has evidence of structural abnormalities such as major stroke or mass on MRI that is likely to interfere with interpretation of a PET scan; 3. Has a history of severe traumatic brain injury (TBI); 4. Has a hemoglobin test (Hb) result of 450 msec). If QTc is >450 at screening, the principal investigator may consult with Avid for approval to enroll; 8. Has a history of additional risk factors for Torsades de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT syndrome) or is taking drugs that are known to cause QT-prolongation; 9. Has donated blood within 6 months prior to the [18F]AV-1451 PET scan day; 10. Has ever participated in an experimental study with a tau or amyloid targeting agent, unless it can be documented that the subject received only placebo during the course of the trial. 11. Has been injected with a previously administered radiopharmaceutical within 6 terminal half-lives OR when total yearly radiation exposure exceeds 10 mSv.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To validate the previously defined simplified tracer kinetic model to quantify specific binding of [18F]AV-1451;Secondary Objective: To assess test-retest variability of quantitative [18F]AV-1451 outcome measures;Primary end point(s): Test-retest variability of [18F]AV-1451 binding;Timepoint(s) of evaluation of this end point: Continuous PET scan from 0-60 and 80-130 minutes post injection and continuous arterial blood draw 0-60 minutes post injection. Repeat after 1 week. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: At baseline and after 1 week follow up | — |
Countries
Netherlands
Contacts
Public ContactDept of Radiology Nuclear Medicine
VU University Medical Center
Outcome results
None listed