Alzheimer's Disease (AD), preclincal stages of AD 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: HLT Classification code 10001897 Term: Alzheimer's disease (incl subtypes) System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 10029205 - Nervous system disorde
Conditions
Interventions
Product Code: 18F-AV-1451
Pharmaceutical Form: Solution for injection
INN or Proposed INN: not applicable
CAS Number: 1522051-90-6
Current Sponsor code: 18F-AV-1451
Other descriptive name: T807
Concen
Sponsors
VU University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Clinically diagnosed with 'subjective cognitive decline' after the standardized dementia screening performed at the VUmc Alzheimer Center - At least 50 years of age - Enrollment in the FIAD cohort (protocol nr 13-256) - Have received or will receive a [18F]Florbetapir PET scan 90 days before or after the [18F]AV-1451 PET scan 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: - Has contraindications for MRI scanning and therefore can not receive brain MRI - Has evidence for structural abnormalities such as major stroke or mass on MRI that is likely to interfere with interpretation of PET scan - Is a woman of childbearing potential who is not surgically sterile, not refraining from sexual activity or not using reliable methods for contraception. Women of childbearing potential must not be pregnant or breast feeding at screening. - Has 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.; - Has ever participated in an experimental study with a tau targeting agent, unless it can be documented that the subject received only placebo during the course of the trial; - Has been injected with a previously administered radiopharmaceutical within 6 terminal half-lives OR when total yearly radiation exposure exceeds 10 mSv - Has a history of severe traumatic brain injury (TBI)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the natural time course of specific [18F]AV-1451 binding in patients with subjective cognitive decline after two and four year follow up a. To compare rate of change in [18F]AV-1451 binding according to baseline amyloid status b. To compare rate of change in [18F]AV-1451 binding according to clinical progression over time ;Secondary Objective: 1. To investigate the relationship between tau pathology, as measured with [18F]AV-1451, and amyloid load, as measured with [18F]Florbetapir 2. To investigate the correlation between [18F]AV-1451 binding and neuropsychological performance 3. To investigate the correlation between [18F]AV-1451 binding and grey matter volume on MRI 4. To investigate the correlation between [18F]AV-1451 binding and CSF measures of amyloid-beta 1-42, total tau and phosphorylated tau ;Primary end point(s): Change in [18F]AV-1451 binding over time;Timepoint(s) of evaluation of this end point: Continuous PET scan from 0-60 and 80-130 minutes post injection. Repeat after 2 and 4 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Relation between [18F]AV-1451 binding and neuropsychological tests, grey matter atrophy on MRI and CSF measures;Timepoint(s) of evaluation of this end point: At baseline and after 2 and 4 years follow up | — |
Countries
Netherlands
Contacts
Public ContactDept of Radiology & Nuclear Medicin
VU University Medical Center
Outcome results
None listed