INEX

Table Description:

Detailed notes for this table are included below.

1.0 Description: Inclusion Exclusion

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:

2.0 Code Book

ITM_NAME

CODE

DECODE_1.0

ELIGIBIL

0

No

ELIGIBIL

1

Yes

INEX1

0

No

INEX1

1

Yes

INEX10

0

No

INEX10

1

Yes

INEX11

0

No

INEX11

1

Yes

INEX12

0

No

INEX12

1

Yes

INEX13

0

No

INEX13

1

Yes

INEX14

0

No

INEX14

1

Yes

INEX15

0

No

INEX15

1

Yes

INEX16

0

No

INEX16

1

Yes

INEX17

0

No

INEX17

1

Yes

INEX2

0

No

INEX2

1

Yes

INEX21

0

No

INEX21

1

Yes

INEX22

0

No

INEX22

1

Yes

INEX23

0

No

INEX23

1

Yes

INEX24

0

No

INEX24

1

Yes

INEX25

0

No

INEX25

1

Yes

INEX26

0

No

INEX26

1

Yes

INEX27

0

No

INEX27

1

Yes

INEX28

0

No

INEX28

1

Yes

INEX29

0

No

INEX29

1

Yes

INEX3

0

No

INEX3

1

Yes

INEX30

0

No

INEX30

1

Yes

INEX31

0

No

INEX31

1

Yes

INEX32

0

No

INEX32

1

Yes

INEX33

0

No

INEX33

1

Yes

INEX34

0

No

INEX34

1

Yes

INEX35

0

No

INEX35

1

Yes

INEX36

0

No

INEX36

1

Yes

INEX37

0

No

INEX37

1

Yes

INEX38

0

No

INEX38

1

Yes

INEX39

0

No

INEX39

1

Yes

INEX4

0

No

INEX4

1

Yes

INEX40

0

No

INEX40

1

Yes

INEX5

0

No

INEX5

1

Yes

INEX6

0

No

INEX6

1

Yes

INEX7

0

No

INEX7

1

Yes

INEX8

0

No

INEX8

1

Yes

INEX9

0

No

INEX9

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