0 Avaliações

ID

44002

Descrição

Global Efficacy Study of MPC-7869 to Treat Patients With Alzheimer's; ODM derived from: https://clinicaltrials.gov/show/NCT00322036

Link

https://clinicaltrials.gov/show/NCT00322036

Palavras-chave

  1. 05/04/2016 05/04/2016 -
  2. 20/09/2021 20/09/2021 -
Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0

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    Eligibility Alzheimer Disease NCT00322036

    Eligibility Alzheimer Disease NCT00322036

    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. have had a diagnosis of probable alzheimer's disease
    Descrição

    alzheimers disease

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0002395
    2. men or women ages greater than or equal to 55 years and living in the community at the time of enrollment (ie, not living in a rest home or nursing care facility).
    Descrição

    gender; age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2]
    C0001779
    3. signed the subject informed consent form (icf) and is willing and able to participate for the duration of the study.
    Descrição

    informed consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    4. ability to read and understand english, dutch, danish, flemish, french, german, italian, spanish or swedish to ensure compliance with cognitive testing and study visit procedures.
    Descrição

    language comprehension

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0233733
    5. at least 6 years of education, or sufficient work history to exclude mental retardation.
    Descrição

    mental retardation; education

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0025362
    UMLS CUI [2]
    C0013658
    6. female subjects must be surgically sterile or postmenopausal for > 1 year.
    Descrição

    contraception status female; postmenopausal

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0420837
    UMLS CUI [1,2]
    C0086287
    UMLS CUI [2]
    C0232970
    7. adequate vision and hearing to participate in study assessments.
    Descrição

    vision; hearing

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0042789
    UMLS CUI [2]
    C0018767
    8. subjects must have a reliable caregiver who can read, understand and speak same language.
    Descrição

    caregiver

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0085537
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. current evidence of other causes of dementia.. .
    Descrição

    dementia

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0497327
    2. history of, or evidence of, active malignancy, except for basal cell carcinoma or squamous cell carcinoma of the skin, within the 24 months prior to entry. men with prostate cancer may be enrolled at the discretion of the sponsor.
    Descrição

    malignancy; basal cell carcinoma; squamous cell carcinoma ; prostate cancer

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2]
    C0007117
    UMLS CUI [3]
    C0007137
    UMLS CUI [4]
    C0600139
    3. use of any investigational therapy within 30 days, or 5 half-lives, whichever is longer, and/or use of ad immunotherapy prior to screening.
    Descrição

    investigational therapy; immunotherapy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0949266
    UMLS CUI [1,2]
    C0205420
    UMLS CUI [2]
    C0021083
    4. major surgery and related complications not resolved within 12 weeks prior to day 1.
    Descrição

    major surgery

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0679637
    5. previous participation in an mpc-7869 clinical study.
    Descrição

    Study Subject Participation Status

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2348568

    Similar models

    Eligibility Alzheimer Disease NCT00322036

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    alzheimers disease
    Item
    1. have had a diagnosis of probable alzheimer's disease
    boolean
    C0002395 (UMLS CUI [1])
    gender; age
    Item
    2. men or women ages greater than or equal to 55 years and living in the community at the time of enrollment (ie, not living in a rest home or nursing care facility).
    boolean
    C0079399 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    informed consent
    Item
    3. signed the subject informed consent form (icf) and is willing and able to participate for the duration of the study.
    boolean
    C0021430 (UMLS CUI [1])
    language comprehension
    Item
    4. ability to read and understand english, dutch, danish, flemish, french, german, italian, spanish or swedish to ensure compliance with cognitive testing and study visit procedures.
    boolean
    C0233733 (UMLS CUI [1])
    mental retardation; education
    Item
    5. at least 6 years of education, or sufficient work history to exclude mental retardation.
    boolean
    C0025362 (UMLS CUI [1])
    C0013658 (UMLS CUI [2])
    contraception status female; postmenopausal
    Item
    6. female subjects must be surgically sterile or postmenopausal for > 1 year.
    boolean
    C0420837 (UMLS CUI [1,1])
    C0086287 (UMLS CUI [1,2])
    C0232970 (UMLS CUI [2])
    vision; hearing
    Item
    7. adequate vision and hearing to participate in study assessments.
    boolean
    C0042789 (UMLS CUI [1])
    C0018767 (UMLS CUI [2])
    caregiver
    Item
    8. subjects must have a reliable caregiver who can read, understand and speak same language.
    boolean
    C0085537 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    dementia
    Item
    1. current evidence of other causes of dementia.. .
    boolean
    C0497327 (UMLS CUI [1])
    malignancy; basal cell carcinoma; squamous cell carcinoma ; prostate cancer
    Item
    2. history of, or evidence of, active malignancy, except for basal cell carcinoma or squamous cell carcinoma of the skin, within the 24 months prior to entry. men with prostate cancer may be enrolled at the discretion of the sponsor.
    boolean
    C0006826 (UMLS CUI [1])
    C0007117 (UMLS CUI [2])
    C0007137 (UMLS CUI [3])
    C0600139 (UMLS CUI [4])
    investigational therapy; immunotherapy
    Item
    3. use of any investigational therapy within 30 days, or 5 half-lives, whichever is longer, and/or use of ad immunotherapy prior to screening.
    boolean
    C0949266 (UMLS CUI [1,1])
    C0205420 (UMLS CUI [1,2])
    C0021083 (UMLS CUI [2])
    major surgery
    Item
    4. major surgery and related complications not resolved within 12 weeks prior to day 1.
    boolean
    C0679637 (UMLS CUI [1])
    Study Subject Participation Status
    Item
    5. previous participation in an mpc-7869 clinical study.
    boolean
    C2348568 (UMLS CUI [1])

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