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])
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])