Age
Item
Is the participant a male or female subjects and will be at least 21 years of age?
boolean
C0001779 (UMLS CUI [1])
Life expectancy
Item
Does the participant have a life expectancy of approximately 6 months?
boolean
C0023671 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Adequate Health
Item
Is the participants health adequate as determined by the investigator to receive [18f]nav4694?
boolean
C0205411 (UMLS CUI [1,1])
C0018684 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
No childbearing potential or negative pregnancy test
Item
Is the (female) participant not of child-bearing potential or will have a negative urine pregnancy test on the day of [18f]nav4694 injection?
boolean
C1705492 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0430057 (UMLS CUI [2,1])
C0439228 (UMLS CUI [2,2])
C1533734 (UMLS CUI [2,3])
C0162778 (UMLS CUI [2,4])
Capability to comply
Item
Does the participant exhibit adequate visual, auditory, and communication capabilities to enable compliance with study procedures? (this includes being able to lie down flat in the MRI or CT and PET scanner for a period of approximately 1 hour)
boolean
C0205411 (UMLS CUI [1,1])
C0234621 (UMLS CUI [1,2])
C3714738 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C0205411 (UMLS CUI [2,1])
C0439825 (UMLS CUI [2,2])
C3714738 (UMLS CUI [2,3])
C2348563 (UMLS CUI [2,4])
C0205411 (UMLS CUI [3,1])
C0009452 (UMLS CUI [3,2])
C3714738 (UMLS CUI [3,3])
C2348563 (UMLS CUI [3,4])
C2584317 (UMLS CUI [4,1])
C0024485 (UMLS CUI [4,2])
C2584317 (UMLS CUI [5,1])
C0040405 (UMLS CUI [5,2])
C2584317 (UMLS CUI [6,1])
C0032743 (UMLS CUI [6,2])
Post mortem brain donation
Item
Is the participant willing to donate his/her brain for post mortem examination upon death? (this consent can be obtained in the manner specific to the country/region involved).
boolean
C0586890 (UMLS CUI [1,1])
C0006104 (UMLS CUI [1,2])
C0004398 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2,1])
C0454664 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Fully informed
Item
Has the participant been fully informed about the study, including provisions of the health insurance portability and accountability act (HIPAA), as applicable, and informed consent or assent has been signed and dated (with time) by the subject and/or the subject's legally acceptable representative (lar) (for individuals with dementia)?
boolean
C0443225 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,3])
C0600593 (UMLS CUI [1,4])
C0021430 (UMLS CUI [2,1])
C0807937 (UMLS CUI [2,2])
C0030705 (UMLS CUI [2,3])
C0021430 (UMLS CUI [3,1])
C0807937 (UMLS CUI [3,2])
C0030705 (UMLS CUI [3,3])
C0023226 (UMLS CUI [3,4])
Scheduled for invasive procedure
Item
Is the participant scheduled for surgery and/or another invasive procedure within the time period of up to 7 days after [18f]nav4694 injection?
boolean
C3242215 (UMLS CUI [1,1])
C4018905 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C4048276 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
C4018905 (UMLS CUI [2,3])
C0687676 (UMLS CUI [2,4])
C0013230 (UMLS CUI [2,5])
Macrovascular disease or tumor
Item
Does the participant have severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumor (metastasis/brain cancer) as verified by mri that prohibits sampling of the required pre-specified ROIs?
boolean
C0006104 (UMLS CUI [1,1])
C2609253 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C0521102 (UMLS CUI [1,4])
C0870078 (UMLS CUI [1,5])
C0807727 (UMLS CUI [1,6])
C0006118 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0870078 (UMLS CUI [2,4])
C0807727 (UMLS CUI [2,5])
Prion disease
Item
Does the participant have any history of any transmissible spongiform encephalopathy (prion disease)?
boolean
C0262926 (UMLS CUI [1,1])
C0162534 (UMLS CUI [1,2])
Radiopharmaceutical administered
Item
Has the participant received any contrast material (x-ray, mri) or radiopharmaceutical within 48 hours prior to, or a therapeutic radiopharmaceutical (e.g., 131-i) within 10 days prior to, or any radiopharmaceutical administration within 10 radioactive half-lives prior to the administration of the investigational product or for whom administration of such substances is planned within 7 days after investigational product administration?
boolean
C2348003 (UMLS CUI [1,1])
C0009924 (UMLS CUI [1,2])
C4018905 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,4])
C0162778 (UMLS CUI [1,5])
C2348003 (UMLS CUI [2,1])
C0182638 (UMLS CUI [2,2])
C4018905 (UMLS CUI [2,3])
C0687676 (UMLS CUI [2,4])
C0162778 (UMLS CUI [2,5])
C2348003 (UMLS CUI [3,1])
C1145010 (UMLS CUI [3,2])
C4018905 (UMLS CUI [3,3])
C0687676 (UMLS CUI [3,4])
C0162778 (UMLS CUI [3,5])
C2348003 (UMLS CUI [4,1])
C0009924 (UMLS CUI [4,2])
C4018905 (UMLS CUI [4,3])
C0332152 (UMLS CUI [4,4])
C0162778 (UMLS CUI [4,5])
C2348003 (UMLS CUI [5,1])
C0182638 (UMLS CUI [5,2])
C4018905 (UMLS CUI [5,3])
C0332152 (UMLS CUI [5,4])
C0162778 (UMLS CUI [5,5])
C2348003 (UMLS CUI [6,1])
C1145010 (UMLS CUI [6,2])
C4018905 (UMLS CUI [6,3])
C0332152 (UMLS CUI [6,4])
C0162778 (UMLS CUI [6,5])
Allergy
Item
Is the participabt allergic to the investigational product or any of its constituents?
boolean
C0700624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0700624 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0729650 (UMLS CUI [2,3])