0 Ratings

ID

14228

Description

Study of the Effect of SR57667B in Patients With Alzheimer's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00285025

Link

https://clinicaltrials.gov/show/NCT00285025

Keywords

  1. 4/5/16 4/5/16 -
Uploaded on

April 5, 2016

DOI

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License

Creative Commons BY 4.0

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    Eligibility Alzheimer Disease NCT00285025

    Eligibility Alzheimer Disease NCT00285025

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    male / female outpatients.
    Description

    gender outpatients

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    UMLS CUI [1,2]
    C0029921 (Outpatients)
    SNOMED
    373864002
    age > 50 years at screening.
    Description

    age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    dementia of alzheimer’s type (dsm-iv 290.0) according to dsm-iv criteria, probable ad according to nincds-adrda criteria, mini-mental state examination score > 12 and < 26.
    Description

    dementia of alzheimers type; mini mental state examination score

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0236649 (Primary degenerative dementia of the Alzheimer type, senile onset, with delirium)
    SNOMED
    4817008
    UMLS CUI [2]
    C2960235 (Mini-mental state examination score)
    SNOMED
    447316007
    untreated or treated for a minimum of 6 months before randomization with a stable dose of the cholinesterase inhibitors
    Description

    therapy cholinesterase inhibitors

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [1,2]
    C0008425 (Cholinesterase Inhibitors)
    generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane).
    Description

    Health Status; ambulatory status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0018759 (Health Status)
    SNOMED
    406221003
    UMLS CUI [2]
    C1550332 (Ambulatory Status)
    presence of a reliable caregiver.
    Description

    caregiver

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0085537 (Caregiver)
    SNOMED
    133932002
    LOINC
    LP76010-5
    patient, identified caregiver and, if applicable, patient surrogate (primary relative, legal guardian, medical proxy) have given their informed written consent and are capable of following study procedures
    Description

    informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    any cause of dementia not due to alzheimer’s disease, delusions, delirium, psychosis, depression, or other significant psychiatric disorder.
    Description

    dementia; alzheimers disease; delusions; psychosis; depression; psychiatric disorder

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0497327 (Dementia)
    SNOMED
    52448006
    LOINC
    LA20372-1
    UMLS CUI [2]
    C0002395 (Alzheimer's Disease)
    SNOMED
    26929004
    UMLS CUI [3]
    C0011253 (Delusions)
    SNOMED
    2073000
    LOINC
    LP121741-5
    UMLS CUI [4]
    C0033975 (Psychotic Disorders)
    SNOMED
    69322001
    UMLS CUI [5]
    C0011570 (Mental Depression)
    LOINC
    MTHU013514
    UMLS CUI [6]
    C0004936 (Mental disorders)
    SNOMED
    74732009
    treatment with any registered or putative cognitive enhancer or disease modifier other than donepezil, rivastigmine or galantamine.
    Description

    donepezil; rivastigmine; galantamine

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0527316 (donepezil)
    SNOMED
    108497001
    UMLS CUI [2]
    C0649350 (rivastigmine)
    SNOMED
    323368009
    UMLS CUI [3]
    C0016967 (galantamine)
    SNOMED
    323377002
    females who are pregnant or breast-feeding. females of child bearing potential (premenopausal female biologically capable of becoming pregnant) must have a confirmed negative serum b–hcg pregnancy test at the screening visit, and must use an acceptable method of birth control.
    Description

    pregnancy; lactating; premenopausal; negative pregnancy test

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    UMLS CUI [3]
    C0232969 (Premenopausal state)
    UMLS CUI [4]
    C0427780 (Pregnancy test negative)
    SNOMED
    250425007
    severe or unstable cardiovascular, respiratory, renal, hematological, endocrinological, neurological or other somatic disease.
    Description

    comorbidity cardiovascular disease respiratory disease hematological disease

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488 (Comorbidity)
    UMLS CUI [1,2]
    C0007222 (Cardiovascular Diseases)
    SNOMED
    49601007
    UMLS CUI [1,3]
    C0035204 (Respiration Disorders)
    SNOMED
    50043002
    LOINC
    LA20369-7
    UMLS CUI [1,4]
    C0018939 (Hematological Disease)
    SNOMED
    34093004
    use of cyp3a4 strong inhibitors
    Description

    cyp3a4 inhibitor

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3830624 (CYP3A4 Inhibitor)
    evidence (detected by history, physical examination and / or laboratory / ecg tests) of any clinically significant or unstable medical disorder that could interfere with the subject's participation in the clinical trial; interfere with the absorption, metabolism or excretion of the study medication; or interfere with the evaluation of the study drug. alterations of laboratory tests or ecg findings of potential clinical significance.
    Description

    Compliance behavior Limited Comorbidity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [1,2]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    UMLS CUI [1,3]
    C0009488 (Comorbidity)

    Similar models

    Eligibility Alzheimer Disease NCT00285025

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    gender outpatients
    Item
    male / female outpatients.
    boolean
    C0079399 (UMLS CUI [1,1])
    C0029921 (UMLS CUI [1,2])
    age
    Item
    age > 50 years at screening.
    boolean
    C0001779 (UMLS CUI [1])
    dementia of alzheimers type; mini mental state examination score
    Item
    dementia of alzheimer’s type (dsm-iv 290.0) according to dsm-iv criteria, probable ad according to nincds-adrda criteria, mini-mental state examination score > 12 and < 26.
    boolean
    C0236649 (UMLS CUI [1])
    C2960235 (UMLS CUI [2])
    therapy cholinesterase inhibitors
    Item
    untreated or treated for a minimum of 6 months before randomization with a stable dose of the cholinesterase inhibitors
    boolean
    C0087111 (UMLS CUI [1,1])
    C0008425 (UMLS CUI [1,2])
    Health Status; ambulatory status
    Item
    generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane).
    boolean
    C0018759 (UMLS CUI [1])
    C1550332 (UMLS CUI [2])
    caregiver
    Item
    presence of a reliable caregiver.
    boolean
    C0085537 (UMLS CUI [1])
    informed consent
    Item
    patient, identified caregiver and, if applicable, patient surrogate (primary relative, legal guardian, medical proxy) have given their informed written consent and are capable of following study procedures
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    dementia; alzheimers disease; delusions; psychosis; depression; psychiatric disorder
    Item
    any cause of dementia not due to alzheimer’s disease, delusions, delirium, psychosis, depression, or other significant psychiatric disorder.
    boolean
    C0497327 (UMLS CUI [1])
    C0002395 (UMLS CUI [2])
    C0011253 (UMLS CUI [3])
    C0033975 (UMLS CUI [4])
    C0011570 (UMLS CUI [5])
    C0004936 (UMLS CUI [6])
    donepezil; rivastigmine; galantamine
    Item
    treatment with any registered or putative cognitive enhancer or disease modifier other than donepezil, rivastigmine or galantamine.
    boolean
    C0527316 (UMLS CUI [1])
    C0649350 (UMLS CUI [2])
    C0016967 (UMLS CUI [3])
    pregnancy; lactating; premenopausal; negative pregnancy test
    Item
    females who are pregnant or breast-feeding. females of child bearing potential (premenopausal female biologically capable of becoming pregnant) must have a confirmed negative serum b–hcg pregnancy test at the screening visit, and must use an acceptable method of birth control.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C0232969 (UMLS CUI [3])
    C0427780 (UMLS CUI [4])
    comorbidity cardiovascular disease respiratory disease hematological disease
    Item
    severe or unstable cardiovascular, respiratory, renal, hematological, endocrinological, neurological or other somatic disease.
    boolean
    C0009488 (UMLS CUI [1,1])
    C0007222 (UMLS CUI [1,2])
    C0035204 (UMLS CUI [1,3])
    C0018939 (UMLS CUI [1,4])
    cyp3a4 inhibitor
    Item
    use of cyp3a4 strong inhibitors
    boolean
    C3830624 (UMLS CUI [1])
    Compliance behavior Limited Comorbidity
    Item
    evidence (detected by history, physical examination and / or laboratory / ecg tests) of any clinically significant or unstable medical disorder that could interfere with the subject's participation in the clinical trial; interfere with the absorption, metabolism or excretion of the study medication; or interfere with the evaluation of the study drug. alterations of laboratory tests or ecg findings of potential clinical significance.
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])

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