AVELIG¶

Table Description: Early Imaging Eligibility

1.0 Description: AV-133 Subject Eligibility

View Source CRFs¶

1.0 CRFs: Click on any PAG_NAME link below to be taken to the CRF used in the PPMI 1.0 Study.

2.0 CRFs: Click on any PAG_NAME link below to be taken to a screenshot of how this eCRF is currently implemented in the PPMI 2.0 Study.

Table Constraints: PATNO, VISIT_ID

ITM_NAME	DSCR	ITM_TYPE
INPPMI2	Enrolled in PPMI 2.0 Clinical protocol	BOOLEAN
INCNST	Able to provide informed consent	BOOLEAN
INPREGNT	Women may not be pregnant, lactating or planning pregnancy during the study	BOOLEAN
EXAVRX1MO	Received any of the following medications that might interfere with 18F-AV-133 PET imaging: tetrabenazine (TBZ) or methylphenidate, reserpine, or amphetamine derivative, within 1 month prior to the Screening 18F-AV-133 injection.	BOOLEAN
EXCARDDX	Have current clinically significant cardiovascular disease or abnormalities on screening ECG (including but not limited to QTc > 450 msec)	BOOLEAN
EXRXQTPRO	Are currently taking medications that are known to cause QT-prolongation	BOOLEAN
EXABCOND	Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation	BOOLEAN

ITM_NAME	CODE	DECODE_2.0
EXABCOND	0	No
EXABCOND	1	Yes
EXAVRX1MO	0	No
EXAVRX1MO	1	Yes
EXCARDDX	0	No
EXCARDDX	1	Yes
EXRXQTPRO	0	No
EXRXQTPRO	1	Yes
INCNST	0	No
INCNST	1	Yes
INPPMI2	0	No
INPPMI2	1	Yes
INPREGNT	0	No
INPREGNT	1	Yes

ITM_NAME	DSCR_1.0
AVCNSTDT	AV-133 Informed consent date
INEX1	Inclusion Exclusion question 1
INEX2	Inclusion Exclusion question 2
INEX3	Inclusion Exclusion question 3
INEX4	Inclusion Exclusion question 4
INEX5	Inclusion Exclusion question 5
INEX6	Inclusion Exclusion question 6
INEX7	Inclusion Exclusion question 7
SIGNCNST	Signed Consent