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17407

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NCT00334568/ GSK-AVA100193: M.Alzheimer GSK A 24 week double-blind, randomized, placebo-controlled, parallel-group dose-raging study to investigate the effects of rosiglitazone (extended release tablets) on cognition in subjects with mild to moderate Alzheimer´s disease. Medicine: rosiglitazone, Condition: Alzheimer´s Disease, Phase: 2, Clinical Study ID: AVA 100193, Sponsor: GSK. This ODM contains Book 2/Visit 2.

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Versioner (2)
  1. 2016-09-12 2016-09-12 -
  2. 2016-10-02 2016-10-02 -
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12 september 2016

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    NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 2

    Engelsk

    NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 2

    1 Formulär  
    General Information
    Beskrivning

    General Information

    Subject Identifier
    Beskrivning

    Subject Identifier

    Datatyp

    integer

    Centre/Investigation Number
    Beskrivning

    Centre/Investigation Number

    Datatyp

    integer

    Study Procedures Chart
    Beskrivning

    Study Procedures Chart

    Procedure: Informed Consent
    Beskrivning

    Procedure: Informed Consent

    Datatyp

    text

    Procedure: PGx/PGm Informed Consent
    Beskrivning

    Procedure: PGx/PGm Informed Consent

    Datatyp

    text

    Procedure: Telephone call to IVRS
    Beskrivning

    Procedure: Telephone call to IVRS

    Datatyp

    text

    Procedure: Inclusion/Exclusion Criteria Review
    Beskrivning

    Procedure: Inclusion/Exclusion Criteria Review

    Datatyp

    text

    Procedure: Demographics
    Beskrivning

    Procedure: Demographics

    Datatyp

    text

    Procedure: Medical history
    Beskrivning

    Procedure: Medical history

    Datatyp

    text

    Procedure: Concomitant Medication
    Beskrivning

    Procedure: Concomitant Medication

    Datatyp

    text

    Procedure: Physical Exam
    Beskrivning

    Procedure: Physical Exam

    Datatyp

    text

    Procedure: Neurological Exam
    Beskrivning

    Procedure: Neurological Exam

    Datatyp

    text

    Procedure: Vital signs
    Beskrivning

    Procedure: Vital signs

    Datatyp

    text

    Procedure: Height & Weight
    Beskrivning

    Procedure: Height & Weight

    Datatyp

    text

    Procedure: ECG
    Beskrivning

    Procedure: ECG

    Datatyp

    text

    Procedure: Echocardiogram
    Beskrivning

    Procedure: Echocardiogram

    Datatyp

    text

    Procedure: Chest X-ray
    Beskrivning

    Procedure: Chest X-ray

    Datatyp

    text

    Procedure: CT Scan
    Beskrivning

    Procedure: CT Scan

    Datatyp

    text

    Procedure: Fasting Laboratory Samples
    Beskrivning

    Procedure: Fasting Laboratory Samples

    Datatyp

    text

    Procedure: Non-Fasting Laboratory Samples
    Beskrivning

    Procedure: Non-Fasting Laboratory Samples

    Datatyp

    text

    Procedure: PGx Sampling
    Beskrivning

    Procedure: PGx Sampling

    Datatyp

    text

    Procedure: PGm Sampling
    Beskrivning

    Procedure: PGm Sampling

    Datatyp

    text

    Procedure: HADS
    Beskrivning

    Procedure: HADS

    Datatyp

    text

    Procedure: MMSE
    Beskrivning

    Procedure: MMSE

    Datatyp

    text

    Procedure: ADAS-cog
    Beskrivning

    Procedure: ADAS-cog

    Datatyp

    text

    Procedure: CIBIC+
    Beskrivning

    Procedure: CIBIC+

    Datatyp

    text

    Procedure: NPI
    Beskrivning

    Procedure: NPI

    Datatyp

    text

    Procedure: DAD
    Beskrivning

    Procedure: DAD

    Datatyp

    text

    Procedure: Recording of AEs
    Beskrivning

    Procedure: Recording of AEs

    Datatyp

    text

    Procedure: Recording of AEs
    Beskrivning

    Procedure: Recording of AEs

    Datatyp

    text

    Procedure: Review Medication Compliance
    Beskrivning

    Procedure: Review Medication Compliance

    Datatyp

    text

    Procedure: Study Conclusion Record
    Beskrivning

    Procedure: Study Conclusion Record

    Datatyp

    text

    Visit 2 (See Description)
    Beskrivning

    Visit 2 (See Description)

    Subject Identifier
    Beskrivning

    Subject Identifier

    Datatyp

    integer

    Visit Date
    Beskrivning

    Visit Date

    Datatyp

    date

    Randomisation (See Description)
    Beskrivning

    Randomisation (See Description)

    Randomisation number
    Beskrivning

    Randomisation number

    Datatyp

    integer

    Vital signs
    Beskrivning

    Vital signs

    Weight
    Beskrivning

    Weight

    Datatyp

    float

    Måttenheter
    • kg
    kg
    Blood pressure: Systolic
    Beskrivning

    Blood pressure will be measured once, after the subject sits quietly for at least 5 minutes.

    Datatyp

    integer

    Blood pressure: Diastolic
    Beskrivning

    Blood pressure

    Datatyp

    integer

    Måttenheter
    • mmHg
    mmHg
    Heart rate
    Beskrivning

    Heart rate

    Datatyp

    integer

    Måttenheter
    • bpm
    bpm
    Central Laboratory (Fasting samples)
    Beskrivning

    Central Laboratory (Fasting samples)

    Date samples taken
    Beskrivning

    Date

    Datatyp

    date

    Pharmacogenetic (PGx) and Pharmacogenomic (PGm) Research (See Description)
    Beskrivning

    Solicit written informed consent from the subject (or legally acceptable representative on behalf of the subject) for pharmacogenetic and pharmacogenomic research. Record the outcome, and details of Pharmacogenetic (PGx) sampling (only where consent is obtained) in the Pharmacogenetic and Pharmatogenomic Research section, Pharmacogenomic (PGm) sampling is recorded in the following two sections.

    Datatyp

    boolean

    PGm-Transcriptomic Research
    Beskrivning

    PGm-Transcriptomic Research

    Has a blood sample been collected for PGm-Transcriptomic research?
    Beskrivning

    Has a blood sample been collected for PGm-Transcriptomic research?

    Datatyp

    boolean

    If yes, record date and time sample taken
    Beskrivning

    If yes, record date and time sample taken

    Datatyp

    datetime

    PGm-Proteomic Research
    Beskrivning

    PGm-Proteomic Research

    Has a blood sample been collected for PGm-Poteomic research?
    Beskrivning

    Has a blood sample been collected for PGm-Poteomic research?

    Datatyp

    boolean

    If yes, record date and time sample taken
    Beskrivning

    If yes, record date and time sample taken

    Datatyp

    datetime

    Volume of one aliquot
    Beskrivning

    Volume of one aliquot

    Datatyp

    float

    Måttenheter
    • ml
    ml
    Length of time the centrifuge ran
    Beskrivning

    Length of time the centrifuge ran

    Datatyp

    integer

    Måttenheter
    • minutes
    minutes
    Temperature of the centrifuge
    Beskrivning

    Temperature of the centrifuge

    Datatyp

    text

    Centrifugation speed
    Beskrivning

    Centrifugation speed

    Datatyp

    integer

    Måttenheter
    • r.p.m
    r.p.m
    Centrifugation rotor radius
    Beskrivning

    Centrifugation rotor radius

    Datatyp

    integer

    Måttenheter
    • cm
    cm
    Time aliquotted samples were placed in the freezer
    Beskrivning

    Time aliquotted samples were placed in the freezer

    Datatyp

    time

    Temperature of freezer
    Beskrivning

    Temperature of freezer

    Datatyp

    integer

    Måttenheter
    • °C
    °C
    Monitor Data Validation Check (See Description)
    Beskrivning

    Monitor Data Validation Check (See Description)

    Investigational product (See Description)
    Beskrivning

    Investigational product (See Description)

    Investigational Product
    Beskrivning

    Investigational Product

    Datatyp

    text

    Start Date
    Beskrivning

    Start Date

    Datatyp

    date

    Stop Date
    Beskrivning

    Stop Date

    Datatyp

    date

    IP Container No.
    Beskrivning

    IP Container No.

    Datatyp

    integer

    Total Number of Tablets Dispensed
    Beskrivning

    Total Number of Tablets Dispensed

    Datatyp

    float

    Total Number of Tablets Returned
    Beskrivning

    Total Number of Tablets Returned

    Datatyp

    float

    Has the subject missed investigational product for > 7 consecutive days?
    Beskrivning

    Discontinuation

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0457454
    Schedule Visit 3 for 14 days (+/- 3 days) after this visit. It is not necessary for the subject to be fasted.
    Beskrivning

    End of visit reminder

    Datatyp

    boolean

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    Similar models

    NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 2

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    General Information
    Subject Identifier
    Item
    Subject Identifier
    integer
    Centre/Investigation Number
    Item
    Centre/Investigation Number
    integer
    Item Group
    Study Procedures Chart
    Item
    Procedure: Informed Consent
    text
    Procedure: Informed Consent
    Code List
    Procedure: Informed Consent
    CL Item
    Visit 1, Wk -2 (1)
    CL Item
    Visit 2, Wk 0 (2)
    CL Item
    Visit 3, Wk 2 (3)
    CL Item
    Visit 4, Wk 4 (4)
    CL Item
    Visit 5, Wk 8 (5)
    CL Item
    Visit 6, Wk 12 (6)
    CL Item
    Visit 7, Wk 16 (7)
    CL Item
    Visit 8, Wk 24 (8)
    CL Item
    Study End Follow-up, Week 26 (9)
    CL Item
    Early Withdrawal  (10)
    CL Item
    Early Withdrawal Follow-up (11)
    Item
    Procedure: PGx/PGm Informed Consent
    text
    Procedure: PGx/PGm Informed Consent
    Code List
    Procedure: PGx/PGm Informed Consent
    CL Item
    Visit 1, Wk -2 (1)
    CL Item
    Visit 2, Wk 0 (2)
    CL Item
    Visit 3, Wk 2 (3)
    CL Item
    Visit 4, Wk 4 (4)
    CL Item
    Visit 5, Wk 8 (5)
    CL Item
    Visit 6, Wk 12 (6)
    CL Item
    Visit 7, Wk 16 (7)
    CL Item
    Visit 8, Wk 24 (8)
    CL Item
    Study End Follow-up, Week 26 (9)
    CL Item
    Early Withdrawal  (10)
    CL Item
    Early Withdrawal Follow-up (11)
    Item
    Procedure: Telephone call to IVRS
    text
    Procedure: Telephone call to IVRS
    Code List
    Procedure: Telephone call to IVRS
    CL Item
    Visit 1, Wk -2 (1)
    CL Item
    Visit 2, Wk 0 (2)
    CL Item
    Visit 3, Wk 2 (3)
    CL Item
    Visit 4, Wk 4 (4)
    CL Item
    Visit 5, Wk 8 (5)
    CL Item
    Visit 6, Wk 12 (6)
    CL Item
    Visit 7, Wk 16 (7)
    CL Item
    Visit 8, Wk 24 (8)
    CL Item
    Study End Follow-up, Week 26 (9)
    CL Item
    Early Withdrawal  (10)
    CL Item
    Early Withdrawal Follow-up (11)
    Item
    Procedure: Inclusion/Exclusion Criteria Review
    text
    Procedure: Inclusion/Exclusion Criteria Review
    Code List
    Procedure: Inclusion/Exclusion Criteria Review
    CL Item
    Visit 1, Wk -2 (1)
    CL Item
    Visit 2, Wk 0 (2)
    CL Item
    Visit 3, Wk 2 (3)
    CL Item
    Visit 4, Wk 4 (4)
    CL Item
    Visit 5, Wk 8 (5)
    CL Item
    Visit 6, Wk 12 (6)
    CL Item
    Visit 7, Wk 16 (7)
    CL Item
    Visit 8, Wk 24 (8)
    CL Item
    Study End Follow-up, Week 26 (9)
    CL Item
    Early Withdrawal  (10)
    CL Item
    Early Withdrawal Follow-up (11)
    Item
    Procedure: Demographics
    text
    Procedure: Demographics
    Code List
    Procedure: Demographics
    CL Item
    Visit 1, Wk -2 (1)
    CL Item
    Visit 2, Wk 0 (2)
    CL Item
    Visit 3, Wk 2 (3)
    CL Item
    Visit 4, Wk 4 (4)
    CL Item
    Visit 5, Wk 8 (5)
    CL Item
    Visit 6, Wk 12 (6)
    CL Item
    Visit 7, Wk 16 (7)
    CL Item
    Visit 8, Wk 24 (8)
    CL Item
    Study End Follow-up, Week 26 (9)
    CL Item
    Early Withdrawal  (10)
    CL Item
    Early Withdrawal Follow-up (11)
    Item
    Procedure: Medical history
    text
    Procedure: Medical history
    Code List
    Procedure: Medical history
    CL Item
    Visit 1, Wk -2 (1)
    CL Item
    Visit 2, Wk 0 (2)
    CL Item
    Visit 3, Wk 2 (3)
    CL Item
    Visit 4, Wk 4 (4)
    CL Item
    Visit 5, Wk 8 (5)
    CL Item
    Visit 6, Wk 12 (6)
    CL Item
    Visit 7, Wk 16 (7)
    CL Item
    Visit 8, Wk 24 (8)
    CL Item
    Study End Follow-up, Week 26 (9)
    CL Item
    Early Withdrawal  (10)
    CL Item
    Early Withdrawal Follow-up (11)
    Item
    Procedure: Concomitant Medication
    text
    Procedure: Concomitant Medication
    Code List
    Procedure: Concomitant Medication
    CL Item
    Visit 1, Wk -2 (1)
    CL Item
    Visit 2, Wk 0 (2)
    CL Item
    Visit 3, Wk 2 (3)
    CL Item
    Visit 4, Wk 4 (4)
    CL Item
    Visit 5, Wk 8 (5)
    CL Item
    Visit 6, Wk 12 (6)
    CL Item
    Visit 7, Wk 16 (7)
    CL Item
    Visit 8, Wk 24 (8)
    CL Item
    Study End Follow-up, Week 26 (9)
    CL Item
    Early Withdrawal  (10)
    CL Item
    Early Withdrawal Follow-up (11)
    Item
    Procedure: Physical Exam
    text
    Procedure: Physical Exam
    Code List
    Procedure: Physical Exam
    CL Item
    Visit 1, Wk -2 (1)
    CL Item
    Visit 2, Wk 0 (2)
    CL Item
    Visit 3, Wk 2 (3)
    CL Item
    Visit 4, Wk 4 (4)
    CL Item
    Visit 5, Wk 8 (5)
    CL Item
    Visit 6, Wk 12 (6)
    CL Item
    Visit 7, Wk 16 (7)
    CL Item
    Visit 8, Wk 24 (8)
    CL Item
    Study End Follow-up, Week 26 (9)
    CL Item
    Early Withdrawal  (10)
    CL Item
    Early Withdrawal Follow-up (11)
    Item
    Procedure: Neurological Exam
    text
    Procedure: Neurological Exam
    Code List
    Procedure: Neurological Exam
    CL Item
    Visit 1, Wk -2 (1)
    CL Item
    Visit 2, Wk 0 (2)
    CL Item
    Visit 3, Wk 2 (3)
    CL Item
    Visit 4, Wk 4 (4)
    CL Item
    Visit 5, Wk 8 (5)
    CL Item
    Visit 6, Wk 12 (6)
    CL Item
    Visit 7, Wk 16 (7)
    CL Item
    Visit 8, Wk 24 (8)
    CL Item
    Study End Follow-up, Week 26 (9)
    CL Item
    Early Withdrawal  (10)
    CL Item
    Early Withdrawal Follow-up (11)
    Item
    Procedure: Vital signs
    text
    Procedure: Vital signs
    Code List
    Procedure: Vital signs
    CL Item
    Visit 1, Wk -2 (1)
    CL Item
    Visit 2, Wk 0 (2)
    CL Item
    Visit 3, Wk 2 (3)
    CL Item
    Visit 4, Wk 4 (4)
    CL Item
    Visit 5, Wk 8 (5)
    CL Item
    Visit 6, Wk 12 (6)
    CL Item
    Visit 7, Wk 16 (7)
    CL Item
    Visit 8, Wk 24 (8)
    CL Item
    Study End Follow-up, Week 26 (9)
    CL Item
    Early Withdrawal  (10)
    CL Item
    Early Withdrawal Follow-up (11)
    Item
    Procedure: Height & Weight
    text
    Procedure: Height & Weight
    Code List
    Procedure: Height & Weight
    CL Item
    Visit 1, Wk -2 (1)
    CL Item
    Visit 2, Wk 0 (2)
    CL Item
    Visit 3, Wk 2 (3)
    CL Item
    Visit 4, Wk 4 (4)
    CL Item
    Visit 5, Wk 8 (5)
    CL Item
    Visit 6, Wk 12 (6)
    CL Item
    Visit 7, Wk 16 (7)
    CL Item
    Visit 8, Wk 24 (8)
    CL Item
    Study End Follow-up, Week 26 (9)
    CL Item
    Early Withdrawal  (10)
    CL Item
    Early Withdrawal Follow-up (11)
    Item
    Procedure: ECG
    text
    Procedure: ECG
    Code List
    Procedure: ECG
    CL Item
    Visit 1, Wk -2 (1)
    CL Item
    Visit 2, Wk 0 (2)
    CL Item
    Visit 3, Wk 2 (3)
    CL Item
    Visit 4, Wk 4 (4)
    CL Item
    Visit 5, Wk 8 (5)
    CL Item
    Visit 6, Wk 12 (6)
    CL Item
    Visit 7, Wk 16 (7)
    CL Item
    Visit 8, Wk 24 (8)
    CL Item
    Study End Follow-up, Week 26 (9)
    CL Item
    Early Withdrawal  (10)
    CL Item
    Early Withdrawal Follow-up (11)
    Item
    Procedure: Echocardiogram
    text
    Procedure: Echocardiogram
    Code List
    Procedure: Echocardiogram
    CL Item
    Visit 1, Wk -2 (1)
    CL Item
    Visit 2, Wk 0 (2)
    CL Item
    Visit 3, Wk 2 (3)
    CL Item
    Visit 4, Wk 4 (4)
    CL Item
    Visit 5, Wk 8 (5)
    CL Item
    Visit 6, Wk 12 (6)
    CL Item
    Visit 7, Wk 16 (7)
    CL Item
    Visit 8, Wk 24 (8)
    CL Item
    Study End Follow-up, Week 26 (9)
    CL Item
    Early Withdrawal  (10)
    CL Item
    Early Withdrawal Follow-up (11)
    Item
    Procedure: Chest X-ray
    text
    Procedure: Chest X-ray
    Code List
    Procedure: Chest X-ray
    CL Item
    Visit 1, Wk -2 (1)
    CL Item
    Visit 2, Wk 0 (2)
    CL Item
    Visit 3, Wk 2 (3)
    CL Item
    Visit 4, Wk 4 (4)
    CL Item
    Visit 5, Wk 8 (5)
    CL Item
    Visit 6, Wk 12 (6)
    CL Item
    Visit 7, Wk 16 (7)
    CL Item
    Visit 8, Wk 24 (8)
    CL Item
    Study End Follow-up, Week 26 (9)
    CL Item
    Early Withdrawal  (10)
    CL Item
    Early Withdrawal Follow-up (11)
    Item
    Procedure: CT Scan
    text
    Procedure: CT Scan
    Code List
    Procedure: CT Scan
    CL Item
    Visit 1, Wk -2 (1)
    CL Item
    Visit 2, Wk 0 (2)
    CL Item
    Visit 3, Wk 2 (3)
    CL Item
    Visit 4, Wk 4 (4)
    CL Item
    Visit 5, Wk 8 (5)
    CL Item
    Visit 6, Wk 12 (6)
    CL Item
    Visit 7, Wk 16 (7)
    CL Item
    Visit 8, Wk 24 (8)
    CL Item
    Study End Follow-up, Week 26 (9)
    CL Item
    Early Withdrawal  (10)
    CL Item
    Early Withdrawal Follow-up (11)
    Item
    Procedure: Fasting Laboratory Samples
    text
    Procedure: Fasting Laboratory Samples
    Code List
    Procedure: Fasting Laboratory Samples
    CL Item
    Visit 1, Wk -2 (1)
    CL Item
    Visit 2, Wk 0 (2)
    CL Item
    Visit 3, Wk 2 (3)
    CL Item
    Visit 4, Wk 4 (4)
    CL Item
    Visit 5, Wk 8 (5)
    CL Item
    Visit 6, Wk 12 (6)
    CL Item
    Visit 7, Wk 16 (7)
    CL Item
    Visit 8, Wk 24 (8)
    CL Item
    Study End Follow-up, Week 26 (9)
    CL Item
    Early Withdrawal  (10)
    CL Item
    Early Withdrawal Follow-up (11)
    Item
    Procedure: Non-Fasting Laboratory Samples
    text
    Procedure: Non-Fasting Laboratory Samples
    Code List
    Procedure: Non-Fasting Laboratory Samples
    CL Item
    Visit 1, Wk -2 (1)
    CL Item
    Visit 2, Wk 0 (2)
    CL Item
    Visit 3, Wk 2 (3)
    CL Item
    Visit 4, Wk 4 (4)
    CL Item
    Visit 5, Wk 8 (5)
    CL Item
    Visit 6, Wk 12 (6)
    CL Item
    Visit 7, Wk 16 (7)
    CL Item
    Visit 8, Wk 24 (8)
    CL Item
    Study End Follow-up, Week 26 (9)
    CL Item
    Early Withdrawal  (10)
    CL Item
    Early Withdrawal Follow-up (11)
    Item
    Procedure: PGx Sampling
    text
    Procedure: PGx Sampling
    Code List
    Procedure: PGx Sampling
    CL Item
    Visit 1, Wk -2 (1)
    CL Item
    Visit 2, Wk 0 (2)
    CL Item
    Visit 3, Wk 2 (3)
    CL Item
    Visit 4, Wk 4 (4)
    CL Item
    Visit 5, Wk 8 (5)
    CL Item
    Visit 6, Wk 12 (6)
    CL Item
    Visit 7, Wk 16 (7)
    CL Item
    Visit 8, Wk 24 (8)
    CL Item
    Study End Follow-up, Week 26 (9)
    CL Item
    Early Withdrawal  (10)
    CL Item
    Early Withdrawal Follow-up (11)
    Item
    Procedure: PGm Sampling
    text
    Procedure: PGm Sampling
    Code List
    Procedure: PGm Sampling
    CL Item
    Visit 1, Wk -2 (1)
    CL Item
    Visit 2, Wk 0 (2)
    CL Item
    Visit 3, Wk 2 (3)
    CL Item
    Visit 4, Wk 4 (4)
    CL Item
    Visit 5, Wk 8 (5)
    CL Item
    Visit 6, Wk 12 (6)
    CL Item
    Visit 7, Wk 16 (7)
    CL Item
    Visit 8, Wk 24 (8)
    CL Item
    Study End Follow-up, Week 26 (9)
    CL Item
    Early Withdrawal  (10)
    CL Item
    Early Withdrawal Follow-up (11)
    Item
    Procedure: HADS
    text
    Procedure: HADS
    Code List
    Procedure: HADS
    CL Item
    Visit 1, Wk -2 (1)
    CL Item
    Visit 2, Wk 0 (2)
    CL Item
    Visit 3, Wk 2 (3)
    CL Item
    Visit 4, Wk 4 (4)
    CL Item
    Visit 5, Wk 8 (5)
    CL Item
    Visit 6, Wk 12 (6)
    CL Item
    Visit 7, Wk 16 (7)
    CL Item
    Visit 8, Wk 24 (8)
    CL Item
    Study End Follow-up, Week 26 (9)
    CL Item
    Early Withdrawal  (10)
    CL Item
    Early Withdrawal Follow-up (11)
    Item
    Procedure: MMSE
    text
    Procedure: MMSE
    Code List
    Procedure: MMSE
    CL Item
    Visit 1, Wk -2 (1)
    CL Item
    Visit 2, Wk 0 (2)
    CL Item
    Visit 3, Wk 2 (3)
    CL Item
    Visit 4, Wk 4 (4)
    CL Item
    Visit 5, Wk 8 (5)
    CL Item
    Visit 6, Wk 12 (6)
    CL Item
    Visit 7, Wk 16 (7)
    CL Item
    Visit 8, Wk 24 (8)
    CL Item
    Study End Follow-up, Week 26 (9)
    CL Item
    Early Withdrawal  (10)
    CL Item
    Early Withdrawal Follow-up (11)
    Item
    Procedure: ADAS-cog
    text
    Procedure: ADAS-cog
    Code List
    Procedure: ADAS-cog
    CL Item
    Visit 1, Wk -2 (1)
    CL Item
    Visit 2, Wk 0 (2)
    CL Item
    Visit 3, Wk 2 (3)
    CL Item
    Visit 4, Wk 4 (4)
    CL Item
    Visit 5, Wk 8 (5)
    CL Item
    Visit 6, Wk 12 (6)
    CL Item
    Visit 7, Wk 16 (7)
    CL Item
    Visit 8, Wk 24 (8)
    CL Item
    Study End Follow-up, Week 26 (9)
    CL Item
    Early Withdrawal  (10)
    CL Item
    Early Withdrawal Follow-up (11)
    Item
    Procedure: CIBIC+
    text
    Procedure: CIBIC+
    Code List
    Procedure: CIBIC+
    CL Item
    Visit 1, Wk -2 (1)
    CL Item
    Visit 2, Wk 0 (2)
    CL Item
    Visit 3, Wk 2 (3)
    CL Item
    Visit 4, Wk 4 (4)
    CL Item
    Visit 5, Wk 8 (5)
    CL Item
    Visit 6, Wk 12 (6)
    CL Item
    Visit 7, Wk 16 (7)
    CL Item
    Visit 8, Wk 24 (8)
    CL Item
    Study End Follow-up, Week 26 (9)
    CL Item
    Early Withdrawal  (10)
    CL Item
    Early Withdrawal Follow-up (11)
    Item
    Procedure: NPI
    text
    Procedure: NPI
    Code List
    Procedure: NPI
    CL Item
    Visit 1, Wk -2 (1)
    CL Item
    Visit 2, Wk 0 (2)
    CL Item
    Visit 3, Wk 2 (3)
    CL Item
    Visit 4, Wk 4 (4)
    CL Item
    Visit 5, Wk 8 (5)
    CL Item
    Visit 6, Wk 12 (6)
    CL Item
    Visit 7, Wk 16 (7)
    CL Item
    Visit 8, Wk 24 (8)
    CL Item
    Study End Follow-up, Week 26 (9)
    CL Item
    Early Withdrawal  (10)
    CL Item
    Early Withdrawal Follow-up (11)
    Item
    Procedure: DAD
    text
    Procedure: DAD
    Code List
    Procedure: DAD
    CL Item
    Visit 1, Wk -2 (1)
    CL Item
    Visit 2, Wk 0 (2)
    CL Item
    Visit 3, Wk 2 (3)
    CL Item
    Visit 4, Wk 4 (4)
    CL Item
    Visit 5, Wk 8 (5)
    CL Item
    Visit 6, Wk 12 (6)
    CL Item
    Visit 7, Wk 16 (7)
    CL Item
    Visit 8, Wk 24 (8)
    CL Item
    Study End Follow-up, Week 26 (9)
    CL Item
    Early Withdrawal  (10)
    CL Item
    Early Withdrawal Follow-up (11)
    Item
    Procedure: Recording of AEs
    text
    Procedure: Recording of AEs
    Code List
    Procedure: Recording of AEs
    CL Item
    Visit 1, Wk -2 (1)
    CL Item
    Visit 2, Wk 0 (2)
    CL Item
    Visit 3, Wk 2 (3)
    CL Item
    Visit 4, Wk 4 (4)
    CL Item
    Visit 5, Wk 8 (5)
    CL Item
    Visit 6, Wk 12 (6)
    CL Item
    Visit 7, Wk 16 (7)
    CL Item
    Visit 8, Wk 24 (8)
    CL Item
    Study End Follow-up, Week 26 (9)
    CL Item
    Early Withdrawal  (10)
    CL Item
    Early Withdrawal Follow-up (11)
    Item
    Procedure: Recording of AEs
    text
    Procedure: Recording of AEs
    Code List
    Procedure: Recording of AEs
    CL Item
    Visit 1, Wk -2 (1)
    CL Item
    Visit 2, Wk 0 (2)
    CL Item
    Visit 3, Wk 2 (3)
    CL Item
    Visit 4, Wk 4 (4)
    CL Item
    Visit 5, Wk 8 (5)
    CL Item
    Visit 6, Wk 12 (6)
    CL Item
    Visit 7, Wk 16 (7)
    CL Item
    Visit 8, Wk 24 (8)
    CL Item
    Study End Follow-up, Week 26 (9)
    CL Item
    Early Withdrawal  (10)
    CL Item
    Early Withdrawal Follow-up (11)
    Item
    Procedure: Review Medication Compliance
    text
    Procedure: Review Medication Compliance
    Code List
    Procedure: Review Medication Compliance
    CL Item
    Visit 1, Wk -2 (1)
    CL Item
    Visit 2, Wk 0 (2)
    CL Item
    Visit 3, Wk 2 (3)
    CL Item
    Visit 4, Wk 4 (4)
    CL Item
    Visit 5, Wk 8 (5)
    CL Item
    Visit 6, Wk 12 (6)
    CL Item
    Visit 7, Wk 16 (7)
    CL Item
    Visit 8, Wk 24 (8)
    CL Item
    Study End Follow-up, Week 26 (9)
    CL Item
    Early Withdrawal  (10)
    CL Item
    Early Withdrawal Follow-up (11)
    Item
    Procedure: Study Conclusion Record
    text
    Procedure: Study Conclusion Record
    Code List
    Procedure: Study Conclusion Record
    CL Item
    Visit 1, Wk -2 (1)
    CL Item
    Visit 2, Wk 0 (2)
    CL Item
    Visit 3, Wk 2 (3)
    CL Item
    Visit 4, Wk 4 (4)
    CL Item
    Visit 5, Wk 8 (5)
    CL Item
    Visit 6, Wk 12 (6)
    CL Item
    Visit 7, Wk 16 (7)
    CL Item
    Visit 8, Wk 24 (8)
    CL Item
    Study End Follow-up, Week 26 (9)
    CL Item
    Early Withdrawal  (10)
    CL Item
    Early Withdrawal Follow-up (11)
    Item Group
    Visit 2 (See Description)
    Subject Identifier
    Item
    Subject Identifier
    integer
    Visit Date
    Item
    Visit Date
    date
    Item Group
    Randomisation (See Description)
    Randomisation number
    Item
    Randomisation number
    integer
    Item Group
    Vital signs
    Weight
    Item
    Weight
    float
    Blood pressure (See Description)
    Item
    Blood pressure: Systolic
    integer
    Blood pressure
    Item
    Blood pressure: Diastolic
    integer
    Heart rate
    Item
    Heart rate
    integer
    Item Group
    Central Laboratory (Fasting samples)
    Date
    Item
    Date samples taken
    date
    Pharmacogenetic (PGx) and Pharmacogenomic (PGm) Research (See Description)
    Item
    Pharmacogenetic (PGx) and Pharmacogenomic (PGm) Research (See Description)
    boolean
    Item Group
    PGm-Transcriptomic Research
    Has a blood sample been collected for PGm-Transcriptomic research?
    Item
    Has a blood sample been collected for PGm-Transcriptomic research?
    boolean
    If yes, record date and time sample taken
    Item
    If yes, record date and time sample taken
    datetime
    Item Group
    PGm-Proteomic Research
    Has a blood sample been collected for PGm-Poteomic research?
    Item
    Has a blood sample been collected for PGm-Poteomic research?
    boolean
    If yes, record date and time sample taken
    Item
    If yes, record date and time sample taken
    datetime
    Volume of one aliquot
    Item
    Volume of one aliquot
    float
    Length of time the centrifuge ran
    Item
    Length of time the centrifuge ran
    integer
    Item
    Temperature of the centrifuge
    text
    Temperature of the centrifuge
    Code List
    Temperature of the centrifuge
    CL Item
    Room temperature (1)
    CL Item
    Refrigerated centrifuge (2)
    Centrifugation speed
    Item
    Centrifugation speed
    integer
    Centrifugation rotor radius
    Item
    Centrifugation rotor radius
    integer
    Time aliquotted samples were placed in the freezer
    Item
    Time aliquotted samples were placed in the freezer
    time
    Temperature of freezer
    Item
    Temperature of freezer
    integer
    Item Group
    Monitor Data Validation Check (See Description)
    Item Group
    Investigational product (See Description)
    Investigational Product
    Item
    Investigational Product
    text
    Start Date
    Item
    Start Date
    date
    Stop Date
    Item
    Stop Date
    date
    IP Container No.
    Item
    IP Container No.
    integer
    Total Number of Tablets Dispensed
    Item
    Total Number of Tablets Dispensed
    float
    Total Number of Tablets Returned
    Item
    Total Number of Tablets Returned
    float
    Discontinuation
    Item
    Has the subject missed investigational product for > 7 consecutive days?
    boolean
    C0457454 (UMLS CUI [1])
    End of visit reminder
    Item
    Schedule Visit 3 for 14 days (+/- 3 days) after this visit. It is not necessary for the subject to be fasted.
    boolean
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