0 Bedömningar

ID

14237

Beskrivning

Study Evaluating the Safety,Tolerability, PK and PD of SAM-531 in the Subjects With Mild to Moderate Alzheimer's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00481520

Länk

https://clinicaltrials.gov/show/NCT00481520

Nyckelord

  1. 2016-04-05 2016-04-05 -
Uppladdad den

5 april 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :


    Inga kommentarer

    Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

    Eligibility Alzheimer Disease NCT00481520

    Eligibility Alzheimer Disease NCT00481520

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. signed and dated written informed consent obtained from the subject or the subject`s legally authorized representative (lar) or next of kin (if applicable), in accordance with the local regulations. the subject`s caregiver must also consent to participate in the study.
    Beskrivning

    informed consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    2. diagnosis of probable alzheimer's disease according to national institute of neurological and communicative disorders and stroke-alzheimer's disease and related disorders association (nincds-adrda) criteria.
    Beskrivning

    alzheimers disease

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0002395
    3. men and postmenopausal or surgically sterile women aged from 50 to 90 inclusive. postmenopausal women must have had 12 months of spontaneous amenorrhea. surgically sterile women are defined as having a hysterectomy, bilateral ovariectomy [oophorectomy], or bilateral tubal ligation. men who are sexually active will need to agree to use a form of contraception that is satisfactory as per the investigator.
    Beskrivning

    gender; age; postmenopausal; amenorrhea; hysterectomy; bilateral ovariectomy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2]
    C0001779
    UMLS CUI [3]
    C0232970
    UMLS CUI [4]
    C0002453
    UMLS CUI [5]
    C0020699
    UMLS CUI [6]
    C0278321
    4. able to participate in all scheduled evaluations with a high probability of completing all required procedures and neuropsychological tests.
    Beskrivning

    compliance behaviour

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1321605
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. significant neurological disease other than alzheimer's disease, which may affect cognition (eg, epilepsy, parkinson disease).
    Beskrivning

    neurological disease; epilepsy; parkinson disease

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0027765
    UMLS CUI [2]
    C0014544
    UMLS CUI [3]
    C0030567
    2. current diagnosis of a major depressive disorder or other major psychiatric symptom according to the criteria of diagnostic and statistical manual of mental disorders, fourth edition text version (dsm-iv-tr).
    Beskrivning

    depressive disorder; psychiatric symptom; dsm-iv-tr

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0011581
    UMLS CUI [2]
    C0233401
    UMLS CUI [3]
    C3710317
    3. current clinically significant systemic illness, which is likely to deteriorate or affect the subject's safety, influence cognitive assessment or ability to complete the study.
    Beskrivning

    Compliance behavior Limited Comorbidity Systemic disease

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0009488
    UMLS CUI [1,4]
    C0442893
    4. any clinically important deviation from normal limits in physical and neurological examination, vital signs, on electrocardiogram (ecg) or clinical laboratory test results that could compromise the study or be detrimental to the subject.
    Beskrivning

    physical examination; vital signs; electrocardiogram

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0031809
    UMLS CUI [2]
    C0518766
    UMLS CUI [3]
    C0013798

    Similar models

    Eligibility Alzheimer Disease NCT00481520

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    informed consent
    Item
    1. signed and dated written informed consent obtained from the subject or the subject`s legally authorized representative (lar) or next of kin (if applicable), in accordance with the local regulations. the subject`s caregiver must also consent to participate in the study.
    boolean
    C0021430 (UMLS CUI [1])
    alzheimers disease
    Item
    2. diagnosis of probable alzheimer's disease according to national institute of neurological and communicative disorders and stroke-alzheimer's disease and related disorders association (nincds-adrda) criteria.
    boolean
    C0002395 (UMLS CUI [1])
    gender; age; postmenopausal; amenorrhea; hysterectomy; bilateral ovariectomy
    Item
    3. men and postmenopausal or surgically sterile women aged from 50 to 90 inclusive. postmenopausal women must have had 12 months of spontaneous amenorrhea. surgically sterile women are defined as having a hysterectomy, bilateral ovariectomy [oophorectomy], or bilateral tubal ligation. men who are sexually active will need to agree to use a form of contraception that is satisfactory as per the investigator.
    boolean
    C0079399 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    C0232970 (UMLS CUI [3])
    C0002453 (UMLS CUI [4])
    C0020699 (UMLS CUI [5])
    C0278321 (UMLS CUI [6])
    compliance behaviour
    Item
    4. able to participate in all scheduled evaluations with a high probability of completing all required procedures and neuropsychological tests.
    boolean
    C1321605 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    neurological disease; epilepsy; parkinson disease
    Item
    1. significant neurological disease other than alzheimer's disease, which may affect cognition (eg, epilepsy, parkinson disease).
    boolean
    C0027765 (UMLS CUI [1])
    C0014544 (UMLS CUI [2])
    C0030567 (UMLS CUI [3])
    depressive disorder; psychiatric symptom; dsm-iv-tr
    Item
    2. current diagnosis of a major depressive disorder or other major psychiatric symptom according to the criteria of diagnostic and statistical manual of mental disorders, fourth edition text version (dsm-iv-tr).
    boolean
    C0011581 (UMLS CUI [1])
    C0233401 (UMLS CUI [2])
    C3710317 (UMLS CUI [3])
    Compliance behavior Limited Comorbidity Systemic disease
    Item
    3. current clinically significant systemic illness, which is likely to deteriorate or affect the subject's safety, influence cognitive assessment or ability to complete the study.
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])
    C0442893 (UMLS CUI [1,4])
    physical examination; vital signs; electrocardiogram
    Item
    4. any clinically important deviation from normal limits in physical and neurological examination, vital signs, on electrocardiogram (ecg) or clinical laboratory test results that could compromise the study or be detrimental to the subject.
    boolean
    C0031809 (UMLS CUI [1])
    C0518766 (UMLS CUI [2])
    C0013798 (UMLS CUI [3])

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial