0 Ratings
ID

12047

Description

Evaluation of the Efficacy and Safety of Azeliragon (TTP488) in Patients With Mild Alzheimer's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02080364

Link

https://clinicaltrials.gov/show/NCT02080364

Keywords

Versions (1)
  1. 9/4/15 9/4/15 - Julian Varghese
Uploaded on

September 4, 2015

DOI

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License

Creative Commons BY 4.0
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    Eligibility Alzheimer's Disease NCT02080364

    English

    Eligibility Alzheimer's Disease NCT02080364

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    diagnosis of probable alzheimer disease (ad) with documented evidence of progression of disease
    Description

    evidence of progression; progression of disease; diagnosis; probable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C1301725
    UMLS CUI [1,3]
    C0332307
    UMLS CUI [2]
    C0242656
    UMLS CUI [3]
    C0011900
    UMLS CUI [4]
    C1709683
    mini mental state examination (mmse) score of 21-26, inclusive
    Description

    examination; score; mental; state

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0260877
    UMLS CUI [2]
    C0449820
    UMLS CUI [3]
    C0004936
    UMLS CUI [4,1]
    C1442065
    UMLS CUI [4,2]
    C0805701
    UMLS CUI [4,3]
    C0027361
    clinical dementia rating global score of 0.5 or 1
    Description

    clinical; dementia; score

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0205210
    UMLS CUI [2]
    C0497327
    UMLS CUI [3]
    C0449820
    rosen-modified hachinski ischemia score less than or equal to 4
    Description

    ischemia; score

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0340561
    UMLS CUI [2]
    C0449820
    brain magnetic resonance imaging (mri) consistent with the diagnosis of probable ad
    Description

    magnetic resonance imaging; diagnosis; probable; brain; mri

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0024485
    UMLS CUI [2]
    C0011900
    UMLS CUI [3]
    C1709683
    UMLS CUI [4]
    C0006104
    UMLS CUI [5]
    C0024485
    concurrent use of cholinesterase inhibitor or memantine with stable dose for at least 3 months prior to randomization
    Description

    cholinesterase; randomization; memantine; stable; dose

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0202207
    UMLS CUI [2,1]
    C1522541
    UMLS CUI [2,2]
    C1515944
    UMLS CUI [2,3]
    C0332307
    UMLS CUI [2,4]
    C0034656
    UMLS CUI [3]
    C0025242
    UMLS CUI [4]
    C0205360
    UMLS CUI [5]
    C3174092
    caregiver willing to participate and be able to attend clinic visits with patient
    Description

    no code found

    Data type

    boolean

    ability to ingest oral medications
    Description

    medications; oral

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0488501
    UMLS CUI [2]
    C0442027
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    significant neurological or psychiatric disease other than alzheimer's disease
    Description

    alzheimer's disease; neurological; other

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0002395
    UMLS CUI [2,1]
    C0449438
    UMLS CUI [2,2]
    C0205494
    UMLS CUI [2,3]
    C0031809
    UMLS CUI [2,4]
    C0030705
    UMLS CUI [3,1]
    C1533734
    UMLS CUI [3,2]
    C1512699
    UMLS CUI [3,3]
    C0205394
    UMLS CUI [3,4]
    C0013227
    participants with evidence or history of severe drug allergies (resulting in dyspnea or severe rash).
    Description

    participants; allergies; dyspnea; severe; drug; rash

    Data type

    boolean

    Alias
    UMLS CUI [1]
    CL106596
    UMLS CUI [2]
    C0020517
    UMLS CUI [3]
    C0013404
    UMLS CUI [4]
    C0205082
    UMLS CUI [5]
    C0013227
    UMLS CUI [6]
    C0015230
    any contraindications to mri (e.g., clinically significant claustrophobia, non-removable ferromagnetic implants). patients with contraindications to mri may undergo computed tomography (ct) on approval by sponsor.
    Description

    clinically significant; computed tomography; contraindications; mri; non

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826633
    UMLS CUI [2]
    C0040405
    UMLS CUI [3,1]
    C0522473
    UMLS CUI [3,2]
    C0003015
    UMLS CUI [4]
    C0024485
    UMLS CUI [5]
    C3530214
    any contraindications to the fdg-pet study (e.g. allergy to any component of the fdg dose) in the cohort undergoing a pet scan.
    Description

    contraindications; component; pet scan; allergy; cohort; study; dose

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0522473
    UMLS CUI [1,2]
    C0003015
    UMLS CUI [2,1]
    C0027651
    UMLS CUI [2,2]
    C0027365
    UMLS CUI [2,3]
    C0008902
    UMLS CUI [3]
    C0032743
    UMLS CUI [4]
    C0020517
    UMLS CUI [5,1]
    C1881010
    UMLS CUI [5,2]
    C0332307
    UMLS CUI [5,3]
    C0205390
    UMLS CUI [6]
    C0008976
    UMLS CUI [7]
    C3174092
    previous exposure to investigational or non-investigational therapies for alzheimer's disease within 6 months of screening
    Description

    alzheimer's disease; screening; therapies; exposure; non

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0002395
    UMLS CUI [2]
    C1409616
    UMLS CUI [3]
    C0087111
    UMLS CUI [4]
    C0332157
    UMLS CUI [5]
    C3530214
    history of cancer within the last 5 years except adequately treated cervical carcinoma in-situ, cutaneous basal cell or squamous cell cancer, or non-progressive prostate cancer not requiring treatment
    Description

    prostate; treatment; cutaneous; cervical; squamous; cancer; last; non

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0033572
    UMLS CUI [2]
    C0087111
    UMLS CUI [3]
    C0221912
    UMLS CUI [4]
    C0205064
    UMLS CUI [5]
    C1182670
    UMLS CUI [6]
    C0006826
    UMLS CUI [7,1]
    C2986440
    UMLS CUI [7,2]
    C1517741
    UMLS CUI [8]
    C3530214
    women of childbearing potential
    Description

    childbearing potential

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1960468
    uncontrolled blood pressure and/or blood pressure above 160/100
    Description

    blood pressure

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005823
    prescription medical food intended for dietary management of the metabolic processes associated with alzheimer's disease.
    Description

    alzheimer's disease; prescription; food

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0002395
    UMLS CUI [2]
    C1521941
    UMLS CUI [3]
    C0016452
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    Similar models

    Eligibility Alzheimer's Disease NCT02080364

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    evidence of progression; progression of disease; diagnosis; probable
    Item
    diagnosis of probable alzheimer disease (ad) with documented evidence of progression of disease
    boolean
    C1457887 (UMLS CUI [1,1])
    C1301725 (UMLS CUI [1,2])
    C0332307 (UMLS CUI [1,3])
    C0242656 (UMLS CUI [2])
    C0011900 (UMLS CUI [3])
    C1709683 (UMLS CUI [4])
    examination; score; mental; state
    Item
    mini mental state examination (mmse) score of 21-26, inclusive
    boolean
    C0260877 (UMLS CUI [1])
    C0449820 (UMLS CUI [2])
    C0004936 (UMLS CUI [3])
    C1442065 (UMLS CUI [4,1])
    C0805701 (UMLS CUI [4,2])
    C0027361 (UMLS CUI [4,3])
    clinical; dementia; score
    Item
    clinical dementia rating global score of 0.5 or 1
    boolean
    C0205210 (UMLS CUI [1])
    C0497327 (UMLS CUI [2])
    C0449820 (UMLS CUI [3])
    ischemia; score
    Item
    rosen-modified hachinski ischemia score less than or equal to 4
    boolean
    C0340561 (UMLS CUI [1])
    C0449820 (UMLS CUI [2])
    magnetic resonance imaging; diagnosis; probable; brain; mri
    Item
    brain magnetic resonance imaging (mri) consistent with the diagnosis of probable ad
    boolean
    C0024485 (UMLS CUI [1])
    C0011900 (UMLS CUI [2])
    C1709683 (UMLS CUI [3])
    C0006104 (UMLS CUI [4])
    C0024485 (UMLS CUI [5])
    cholinesterase; randomization; memantine; stable; dose
    Item
    concurrent use of cholinesterase inhibitor or memantine with stable dose for at least 3 months prior to randomization
    boolean
    C0202207 (UMLS CUI [1])
    C1522541 (UMLS CUI [2,1])
    C1515944 (UMLS CUI [2,2])
    C0332307 (UMLS CUI [2,3])
    C0034656 (UMLS CUI [2,4])
    C0025242 (UMLS CUI [3])
    C0205360 (UMLS CUI [4])
    C3174092 (UMLS CUI [5])
    no code found
    Item
    caregiver willing to participate and be able to attend clinic visits with patient
    boolean
    medications; oral
    Item
    ability to ingest oral medications
    boolean
    C0488501 (UMLS CUI [1])
    C0442027 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    alzheimer's disease; neurological; other
    Item
    significant neurological or psychiatric disease other than alzheimer's disease
    boolean
    C0002395 (UMLS CUI [1])
    C0449438 (UMLS CUI [2,1])
    C0205494 (UMLS CUI [2,2])
    C0031809 (UMLS CUI [2,3])
    C0030705 (UMLS CUI [2,4])
    C1533734 (UMLS CUI [3,1])
    C1512699 (UMLS CUI [3,2])
    C0205394 (UMLS CUI [3,3])
    C0013227 (UMLS CUI [3,4])
    participants; allergies; dyspnea; severe; drug; rash
    Item
    participants with evidence or history of severe drug allergies (resulting in dyspnea or severe rash).
    boolean
    CL106596 (UMLS CUI [1])
    C0020517 (UMLS CUI [2])
    C0013404 (UMLS CUI [3])
    C0205082 (UMLS CUI [4])
    C0013227 (UMLS CUI [5])
    C0015230 (UMLS CUI [6])
    clinically significant; computed tomography; contraindications; mri; non
    Item
    any contraindications to mri (e.g., clinically significant claustrophobia, non-removable ferromagnetic implants). patients with contraindications to mri may undergo computed tomography (ct) on approval by sponsor.
    boolean
    C2826633 (UMLS CUI [1])
    C0040405 (UMLS CUI [2])
    C0522473 (UMLS CUI [3,1])
    C0003015 (UMLS CUI [3,2])
    C0024485 (UMLS CUI [4])
    C3530214 (UMLS CUI [5])
    contraindications; component; pet scan; allergy; cohort; study; dose
    Item
    any contraindications to the fdg-pet study (e.g. allergy to any component of the fdg dose) in the cohort undergoing a pet scan.
    boolean
    C0522473 (UMLS CUI [1,1])
    C0003015 (UMLS CUI [1,2])
    C0027651 (UMLS CUI [2,1])
    C0027365 (UMLS CUI [2,2])
    C0008902 (UMLS CUI [2,3])
    C0032743 (UMLS CUI [3])
    C0020517 (UMLS CUI [4])
    C1881010 (UMLS CUI [5,1])
    C0332307 (UMLS CUI [5,2])
    C0205390 (UMLS CUI [5,3])
    C0008976 (UMLS CUI [6])
    C3174092 (UMLS CUI [7])
    alzheimer's disease; screening; therapies; exposure; non
    Item
    previous exposure to investigational or non-investigational therapies for alzheimer's disease within 6 months of screening
    boolean
    C0002395 (UMLS CUI [1])
    C1409616 (UMLS CUI [2])
    C0087111 (UMLS CUI [3])
    C0332157 (UMLS CUI [4])
    C3530214 (UMLS CUI [5])
    prostate; treatment; cutaneous; cervical; squamous; cancer; last; non
    Item
    history of cancer within the last 5 years except adequately treated cervical carcinoma in-situ, cutaneous basal cell or squamous cell cancer, or non-progressive prostate cancer not requiring treatment
    boolean
    C0033572 (UMLS CUI [1])
    C0087111 (UMLS CUI [2])
    C0221912 (UMLS CUI [3])
    C0205064 (UMLS CUI [4])
    C1182670 (UMLS CUI [5])
    C0006826 (UMLS CUI [6])
    C2986440 (UMLS CUI [7,1])
    C1517741 (UMLS CUI [7,2])
    C3530214 (UMLS CUI [8])
    childbearing potential
    Item
    women of childbearing potential
    boolean
    C1960468 (UMLS CUI [1])
    blood pressure
    Item
    uncontrolled blood pressure and/or blood pressure above 160/100
    boolean
    C0005823 (UMLS CUI [1])
    alzheimer's disease; prescription; food
    Item
    prescription medical food intended for dietary management of the metabolic processes associated with alzheimer's disease.
    boolean
    C0002395 (UMLS CUI [1])
    C1521941 (UMLS CUI [2])
    C0016452 (UMLS CUI [3])
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