ID

14228

Beschrijving

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

Trefwoorden

Versies (1)
  1. 05-04-16 05-04-16 -
Geüploaded op

5 april 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Alzheimer Disease NCT00285025

Engels

Eligibility Alzheimer Disease NCT00285025

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male / female outpatients.
Beschrijving

gender outpatients

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0029921
age > 50 years at screening.
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
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.
Beschrijving

dementia of alzheimers type; mini mental state examination score

Datatype

boolean

Alias
UMLS CUI [1]
C0236649
UMLS CUI [2]
C2960235
untreated or treated for a minimum of 6 months before randomization with a stable dose of the cholinesterase inhibitors
Beschrijving

therapy cholinesterase inhibitors

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0008425
generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane).
Beschrijving

Health Status; ambulatory status

Datatype

boolean

Alias
UMLS CUI [1]
C0018759
UMLS CUI [2]
C1550332
presence of a reliable caregiver.
Beschrijving

caregiver

Datatype

boolean

Alias
UMLS CUI [1]
C0085537
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
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

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

Datatype

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2]
C0002395
UMLS CUI [3]
C0011253
UMLS CUI [4]
C0033975
UMLS CUI [5]
C0011570
UMLS CUI [6]
C0004936
treatment with any registered or putative cognitive enhancer or disease modifier other than donepezil, rivastigmine or galantamine.
Beschrijving

donepezil; rivastigmine; galantamine

Datatype

boolean

Alias
UMLS CUI [1]
C0527316
UMLS CUI [2]
C0649350
UMLS CUI [3]
C0016967
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.
Beschrijving

pregnancy; lactating; premenopausal; negative pregnancy test

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0232969
UMLS CUI [4]
C0427780
severe or unstable cardiovascular, respiratory, renal, hematological, endocrinological, neurological or other somatic disease.
Beschrijving

comorbidity cardiovascular disease respiratory disease hematological disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0007222
UMLS CUI [1,3]
C0035204
UMLS CUI [1,4]
C0018939
use of cyp3a4 strong inhibitors
Beschrijving

cyp3a4 inhibitor

Datatype

boolean

Alias
UMLS CUI [1]
C3830624
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.
Beschrijving

Compliance behavior Limited Comorbidity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
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Similar models

Eligibility Alzheimer Disease NCT00285025

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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