INEX¶

Table Description: Inclusion Exclusion

Detailed notes for this table are included below.

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.

2.0 Data Dictionary¶

Table Constraints: PATNO, VISIT_ID

ITM_NAME	DSCR	ITM_TYPE
INPDDX30	Male or female age 30 years or older at Screening Visit.	BOOLEAN
IN2YRPD	A diagnosis of Parkinson disease for 2 years or less at Screening Visit.	BOOLEAN
INNOMED6MO	Not expected to require PD medication within at least 6 months from Baseline.	BOOLEAN
IN2CARDPD	Patients must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia); OR either asymmetric resting tremor or asymmetric bradykinesia.	BOOLEAN
INHOLDRX	Individuals taking any of the following drugs: alpha methyldopa, methylphenidate, amphetamine derivatives or modafinil, must be willing and medically able to hold the medication for at least 5 half-lives before DaTscan imaging.	BOOLEAN
INCNST	Able to provide informed consent.	BOOLEAN
INPREGNT	Male or a female of childbearing potential who is not pregnant, lactating, or planning pregnancy during the study must have a negative pregnancy test on day of Screening DaTscan imaging test prior to injection of DaTscan	BOOLEAN
EXCURPDRX	Currently taking levodopa, dopamine agonists, MAO-B inhibitors (e.g., selegiline, rasagiline), amantadine or another PD medication.	BOOLEAN
EX60DYPDRX	Has taken levodopa, dopamine agonists, MAO-B inhibitors or amantadine within 60 days of Baseline visit.	BOOLEAN
EX90DYPDRX	Has taken levodopa or dopamine agonists prior to Baseline visit for more than a total of 90 days.	BOOLEAN
EXATYPPD	Atypical PD syndromes due to either drugs (e.g., metoclopramide, flunarizine, neuroleptics) or metabolic disorders (e.g. Wilson’s disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy).	BOOLEAN
EXDEMNTDX	A clinical diagnosis of dementia as determined by the investigator.	BOOLEAN
EXNEURMRI	Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).	BOOLEAN
EXDARX6MO	Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening visit.	BOOLEAN
EXANTCOAG	Current treatment with anticoagulants (e.g., coumadin, heparin, oral thrombin inhibitors) that might preclude safe completion of the lumbar puncture.	BOOLEAN
EXUNSAFLP	Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.	BOOLEAN
EXABCOND	Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.	BOOLEAN
INPRESCRN	Confirmation that participant is eligible based on centrally determined predictive criteria including the University of Pennsylvania Smell Identification Test (UPSIT), prior to completion of Screening DaTscan imaging.	BOOLEAN
INAGE6030	Male or female age 60 years or older (except age 30 years or older for SNCA, or rare genetic mutations (such as Parkin or Pink1) participants).	BOOLEAN
INDATSCN	Confirmation that participant is eligible based on Screening DaTscan imaging.	BOOLEAN
EXPDDEMDX	Clinical diagnosis of PD, other parkinsonism, or dementia.	BOOLEAN
INHY1OR2	Hoehn and Yahr stage I or II at Baseline.	BOOLEAN
INAGE30	Male or female age 30 years or older at Screening visit.	BOOLEAN
EXFAMPD	First degree relative with PD (i.e. biologic parent, sibling, child)	BOOLEAN
EXNEURCURR	Current or active clinically significant neurological disorder (in the opinion of the Investigator).	BOOLEAN
INLRRK2GBA	Confirmation of causative LRRK2 or GBA (willingness to undergo genetic testing as part of genetic screening and be informed of genetic testing results, or documentation of prior genetic testing results).	BOOLEAN
INPDSC	Parkinson’s disease diagnosis at Screening Visit.	BOOLEAN
INSNCAPARK	Confirmation of causative SNCA or rare genetic variant (such as Parkin or Pink1) (willingness to undergo genetic testing as part of genetic screening and be informed of genetic testing results, or approved documentation of prior genetic testing results).	BOOLEAN
INHY1TO3	Hoehn and Yahr stage I or II or III at Baseline.	BOOLEAN

2.0 Code Book¶

ITM_NAME	CODE	DECODE_2.0
EX60DYPDRX	0	No
EX60DYPDRX	1	Yes
EX90DYPDRX	0	No
EX90DYPDRX	1	Yes
EXABCOND	0	No
EXABCOND	1	Yes
EXANTCOAG	0	No
EXANTCOAG	1	Yes
EXATYPPD	0	No
EXATYPPD	1	Yes
EXCURPDRX	0	No
EXCURPDRX	1	Yes
EXDARX6MO	0	No
EXDARX6MO	1	Yes
EXDEMNTDX	0	No
EXDEMNTDX	1	Yes
EXFAMPD	0	No
EXFAMPD	1	Yes
EXNEURCURR	0	No
EXNEURCURR	1	Yes
EXNEURMRI	0	No
EXNEURMRI	1	Yes
EXPDDEMDX	0	No
EXPDDEMDX	1	Yes
EXUNSAFLP	0	No
EXUNSAFLP	1	Yes
IN2CARDPD	0	No
IN2CARDPD	1	Yes
IN2YRPD	0	No
IN2YRPD	1	Yes
INAGE30	0	No
INAGE30	1	Yes
INAGE6030	0	No
INAGE6030	1	Yes
INCNST	0	No
INCNST	1	Yes
INDATSCN	0	No
INDATSCN	1	Yes
INHOLDRX	0	No
INHOLDRX	1	Yes
INHY1OR2	0	No
INHY1OR2	1	Yes
INHY1TO3	0	No
INHY1TO3	1	Yes
INLRRK2GBA	0	No
INLRRK2GBA	1	Yes
INNOMED6MO	0	No
INNOMED6MO	1	Yes
INPDDX30	0	No
INPDDX30	1	Yes
INPDSC	0	No
INPDSC	1	Yes
INPREGNT	0	No
INPREGNT	1	Yes
INPRESCRN	0	No
INPRESCRN	1	Yes
INSNCAPARK	0	No
INSNCAPARK	1	Yes

Missing Columns¶

ITM_NAME	DSCR_1.0
ELIGIBIL	Is the Subject eligible for enrollment
INEX1	Inclusion question 1
INEX10	Inclusion question 10
INEX11	Inclusion question 11
INEX12	Inclusion question 12
INEX13	Inclusion question 13
INEX14	Inclusion question 14
INEX15	Inclusion question 15
INEX16	Inclusion question 16
INEX17	Inclusion question 17
INEX2	Inclusion question 2
INEX21	Exclusion question 1
INEX22	Exclusion question 2
INEX23	Exclusion question 3
INEX24	Exclusion question 4
INEX25	Exclusion question 5
INEX26	Exclusion question 6
INEX27	Exclusion question 7
INEX28	Exclusion question 8
INEX29	Exclusion question 9
INEX3	Inclusion question 3
INEX30	Exclusion question 10
INEX31	Exclusion question 11
INEX32	Exclusion question 12
INEX33	Exclusion question 13
INEX34	Exclusion question 14
INEX35	Exclusion question 15
INEX36	Exclusion question 16
INEX37	Exclusion question 17
INEX38	Exclusion question 18
INEX39	Exclusion question 19
INEX4	Inclusion question 4
INEX40	Exclusion question 20
INEX5	Inclusion question 5
INEX6	Inclusion question 6
INEX7	Inclusion question 7
INEX8	Inclusion question 8
INEX9	Inclusion question 9
WAIVERCD	Protocol Deviation Code

Details¶

SOA

The INEX CRF (Inclusion/Exclusion Criteria) is completed at Screening and Baseline for all cohorts (Healthy Control, PD, and Prodromal).

Variable Names

The variable names in PPMI 1.0 were named after the question number, and the description didn’t provide any information on what the question was actually asking. For example, ITM_NAME INEX1 had the description “Inclusion question 1”. In PPMI 2.0, this format was changed. Both the ITM_NAME and DSCR were modified to provide detail on what the question is asking. However, many of the questions in PPMI 1.0 have the same (or very similar) description to a question in the new 2.0 form version. See the table below for details on which questions have a corresponding match to a question in PPMI 1.0.

ITM_NAME_2.0	DSCR_2.0	ITM_NAME_1.0	PROMPT_1.0
INPDDX30	Male or female age 30 years or older at time of PD diagnosis.	INEX5	Male or female age 30 years or older at time of PD diagnosis.
IN2YRPD	A diagnosis of Parkinson disease for 2 years or less at Screening.	INEX2	A diagnosis of Parkinson disease for 2 years or less at Screening.
INNOMED6MO	Not expected to require PD medication within at least 6 months from Baseline.	INEX4	Not expected to require PD medication within at least 6 months from Baseline.
IN2CARDPD	Patients must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia); OR either asymmetric resting tremor or asymmetric bradykinesia.	INEX1	Subjects must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia); OR either asymmetric resting tremor or asymmetric bradykinesia.
INHOLDRX	Individuals taking any of the following drugs: alpha methyldopa, methylphenidate, amphetamine derivatives or modafinil, must be willing and medically able to hold the medication for at least 5 half-lives before DaTscan imaging.
INCNST	Able to provide informed consent.	INEX7	Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations.
INPREGNT	Women may not be pregnant, lactating or planning pregnancy during the study.	INEX9	Women may not be pregnant, lactating or planning pregnancy during the course of the study.
EXCURPDRX	Currently taking levodopa, dopamine agonists, MAO-B inhibitors (e.g., selegiline, rasagiline), amantadine or another PD medication.	INEX22	Currently taking levodopa, dopamine agonists, MAO-B inhibitors, (e.g. selegiline, rasagiline) amantadine or other PD medication.
EX60DYPDRX	Has taken levodopa, dopamine agonists, MAO-B inhibitors or amantadine within 60 days of Baseline visit.	INEX23	Has taken levodopa, dopamine agonists, MAO-B inhibitors or amantadine within 60 days of Baseline.
EX90DYPDRX	Has taken levodopa or dopamine agonists prior to Baseline visit for more than a total of 90 days.
EXATYPPD	Atypical PD syndromes due to either drugs (e.g., metoclopramide, flunarizine, neuroleptics) or metabolic disorders (e.g. Wilson’s disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy).
EXDEMNTDX	A clinical diagnosis of dementia as determined by the investigator.	INEX25	A clinical diagnosis of dementia as determined by the investigator.
EXNEURMRI	Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).	INEX31	Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).
EXDARX6MO	Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening visit.	INEX26	Received any of the following drugs that might interfere with dopamine transporter SPECT imaging: Neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of Screening.
EXANTCOAG	Current treatment with anticoagulants (e.g., coumadin, heparin, oral thrombin inhibitors) that might preclude safe completion of the lumbar puncture.	INEX27	Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.
EXUNSAFLP	Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.	INEX28	Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
EXABCOND	Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.	INEX29	Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
INREMOTE	Enrolled in PPMI 2.0 Remote and based on remote assessments, including hyposmia, are eligible for PPMI 2.0 Clinical.
INAGE6030	Male or female age 60 years or older (except age 30 years or older for SNCA, or rare genetic mutations (such as Parkin or Pink1) participants).
INDATSCN	Confirmation that participant is eligible based on Screening DaTscan imaging.
EXPDDEMDX	Clinical diagnosis of PD, other parkinsonism, or dementia.
INHY1OR2	Hoehn and Yahr stage I or II at Baseline.	INEX3	Hoehn and Yahr stage I or II.
INAGE30	Male or female age 30 years or older at Screening visit.	INEX10	Male or female age 30 years or older at Screening.
EXFAMPD	First degree relative with PD (parent, sibling, child).	INEX34	First degree relative with idiopathic PD (parent, sibling, child).
EXNEURCURR	Current or active clinically significant neurological disorder (in the opinion of the Investigator).	INEX33	Current or active clinically significant neurological disorder (in the opinion of the Investigator).
INLRRK2GBA	Confirmation of causative LRRK2 or GBA (willingness to undergo genetic testing as part of genetic screening and be informed of genetic testing results, or documentation of prior genetic testing results).
INPDSC	Parkinson’s disease diagnosis at Screening.
INSNCAPARK	Confirmation of causative SNCA or Parkin mutation (willingness to undergo genetic testing as part of genetic screening and be informed of genetic testing results, or documentation of prior genetic testing results).
INHY1TO3	Hoehn and Yahr stage I or II or III at Baseline.

Cohorts

Different cohorts receive different INEX forms. The table below maps the INEX form name to the study cohort:

PAG_NAME	Cohort Inclusion/Exclusion Form
AVELIG	Early Imaging Eligibility
INEXHC	Healthy Control Inclusion/Exclusion Criteria
INEXLRRK2	Parkinson’s Disease (LRRK2 or GBA) Inclusion/Exclusion Criteria
INEXPD	Parkinson’s Disease Inclusion/Exclusion Criteria
INEXPRO	Prodromal Inclusion/Exclusion Criteria
INEXSNCA	Parkinson’s Disease (SNCA or Parkin) Inclusion/Exclusion Criteria

Each of these INEX forms contains different questions. See the table below to see which INEX questions are asked on each INEX form.

MOD_NAME	AVELIG	INEXHC	INEXLRRK2	INEXPD	INEXPRO	INEXSNCA
EX60DYPDRX				X
EX90DYPDRX				X
EXABCOND	X	X	X	X	X	X
EXANTCOAG		X	X	X	X	X
EXATYPPD				X
EXAVRX1MO	X
EXCARDDX	X
EXCURPDRX				X
EXDARX6MO		X	X	X	X	X
EXDEMNTDX				X
EXFAMPD		X
EXNEURCURR		X
EXNEURMRI		X		X
EXPDDEMDX					X
EXRXQTPRO	X
EXUNSAFLP		X	X	X	X	X
IN2CARDPD			X	X		X
IN2YRPD			X	X
INAGE30		X	X			X
INAGE6030					X
INCNST	X	X	X	X	X	X
INDATSCN		X	X	X	X	X
INHOLDRX		X	X	X	X	X
INHY1OR2			X	X
INHY1TO3						X
INLRRK2GBA			X
INNOMED6MO				X
INPDDX30				X
INPDSC						X
INPPMI2	X
INPREGNT	X	X	X	X	X	X
INPRESCRN					X
INSNCAPARK						X