ID

44776

Beskrivning

Study of STA-1 as an Add-on Treatment to Donepezil; ODM derived from: https://clinicaltrials.gov/show/NCT01255046

Länk

https://clinicaltrials.gov/show/NCT01255046

Nyckelord

Versioner (3)
  1. 2015-08-30 2015-08-30 -
  2. 2021-04-13 2021-04-13 - Dr. rer. medic Philipp Neuhaus
  3. 2021-11-18 2021-11-18 -
Rättsinnehavare

Sinphar Pharmaceutical Co., Ltd

Uppladdad den

18 november 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Alzheimer Disease NCT01255046

Engelsk

Eligibility Alzheimer Disease NCT01255046

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

male or female patient aged ≥ 50 years;
Beskrivning

male or female; patient age

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
probable alzheimer's disease diagnosed by the national institute of neurological and communicative disorders and stroke and the alzheimer's disease and related disorders association (nincds-adrda) criteria;
Beskrivning

probable alzheimer's disease diagnosed by the national institute of neurological and communicative disorders and stroke and the alzheimer's disease and related disorders association (nincds-adrda) criteria;

Datatyp

boolean

Alias
UMLS CUI [1]
C0002395
UMLS CUI [2]
C0038454
mmse score between 10-26, inclusive;
Beskrivning

mmse score between 10-26, inclusive;

Datatyp

boolean

Alias
UMLS CUI [1]
C2225229
patient has been treated with donepezil 10 mg per day for at least 3 months prior to screening;
Beskrivning

patient has been treated with donepezil 10 mg per day for at least 3 months prior to screening;

Datatyp

boolean

Alias
UMLS CUI [1]
C0527316
patient able to participate in all study evaluations and ingest oral medication as indicated;
Beskrivning

patient able to participate in all study evaluations and ingest oral medication as indicated;

Datatyp

boolean

Alias
UMLS CUI [1]
C0175795
UMLS CUI [2]
C0677408
patient has a responsible caregiver who will accompany the patient to all clinic visits during the study;
Beskrivning

patient has a responsible caregiver who will accompany the patient to all clinic visits during the study;

Datatyp

boolean

Alias
UMLS CUI [1]
C0150162
patient and the responsible caregiver have provided written informed consent before undergoing any study procedures.
Beskrivning

patient and the responsible caregiver have provided written informed consent before undergoing any study procedures.

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

brain image (computed tomography (ct) scan or magnetic resonance imaging (mri) done within past 12 months prior to the study) and laboratory tests to exclude secondary dementia or non-alzheimer's dementia;
Beskrivning

brain image (computed tomography (ct) scan or magnetic resonance imaging (mri) done within past 12 months prior to the study) and laboratory tests to exclude secondary dementia or non-alzheimer's dementia;

Datatyp

boolean

Alias
UMLS CUI [1]
C0024485
UMLS CUI [2]
C0040405
UMLS CUI [3]
C0587081
patient with significant clinically central nervous system illness other than ad (e.g. parkinson's disease, human immunodeficiency virus (hiv) induced dementia, hachinski ischaemic score (his) >4) or dementia complicated by other organic disease or delirium;
Beskrivning

patient with significant clinically central nervous system illness other than ad (e.g. parkinson's disease, human immunodeficiency virus (hiv) induced dementia, hachinski ischaemic score (his) >4) or dementia complicated by other organic disease or delirium;

Datatyp

boolean

Alias
UMLS CUI [1]
C0007682
patient with a severe or uncontrolled diagnostic and statistical manual of mental disorders (dsm-iv) axis i disorder other than alzheimer's disease, including amnestic disorders, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, or post-traumatic stress disorder;
Beskrivning

patient with a severe or uncontrolled diagnostic and statistical manual of mental disorders (dsm-iv) axis i disorder other than alzheimer's disease, including amnestic disorders, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, or post-traumatic stress disorder;

Datatyp

boolean

Alias
UMLS CUI [1]
C0004936
patient suffering from cerebral disturbances following a stroke or a cerebral trauma (if the event occurred within the last 6 months);
Beskrivning

patient suffering from cerebral disturbances following a stroke or a cerebral trauma (if the event occurred within the last 6 months);

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0234387
UMLS CUI [2,1]
C0018674
UMLS CUI [2,2]
C0234387
patient with a history of hypersensitivity to study drugs;
Beskrivning

patient with a history of hypersensitivity to study drugs;

Datatyp

boolean

Alias
UMLS CUI [1]
C0013182
patient who has a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine (e.g., addison's disease), immune, neurologic, or hematologic disease as determined by the clinical judgment of the investigator;
Beskrivning

patient who has a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine (e.g., addison's disease), immune, neurologic, or hematologic disease as determined by the clinical judgment of the investigator;

Datatyp

boolean

Alias
UMLS CUI [1]
C3843040
participation in any research study within the last 30 days;
Beskrivning

participation in any research study within the last 30 days;

Datatyp

boolean

Alias
UMLS CUI [1]
C0008976
patient with significant alcohol or drug abuse as judged by the investigator.
Beskrivning

patient with significant alcohol or drug abuse as judged by the investigator.

Datatyp

boolean

Alias
UMLS CUI [1]
C0237123
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Similar models

Eligibility Alzheimer Disease NCT01255046

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
male or female; patient age
Item
male or female patient aged ≥ 50 years;
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
alzheimer's disease; neurological; probable; related; stroke
Item
probable alzheimer's disease diagnosed by the national institute of neurological and communicative disorders and stroke and the alzheimer's disease and related disorders association (nincds-adrda) criteria;
boolean
C0002395 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
score
Item
mmse score between 10-26, inclusive;
boolean
C2225229 (UMLS CUI [1])
screening; day; per
Item
patient has been treated with donepezil 10 mg per day for at least 3 months prior to screening;
boolean
C0527316 (UMLS CUI [1])
medication; study; oral; all
Item
patient able to participate in all study evaluations and ingest oral medication as indicated;
boolean
C0175795 (UMLS CUI [1])
C0677408 (UMLS CUI [2])
study; all
Item
patient has a responsible caregiver who will accompany the patient to all clinic visits during the study;
boolean
C0150162 (UMLS CUI [1])
written informed consent before randomization; procedure(s); procedures; study
Item
patient and the responsible caregiver have provided written informed consent before undergoing any study procedures.
boolean
C0021430 (UMLS CUI [1])
magnetic resonance imaging; computed tomography; laboratory tests; dementia; brain; study; done; mri; non
Item
brain image (computed tomography (ct) scan or magnetic resonance imaging (mri) done within past 12 months prior to the study) and laboratory tests to exclude secondary dementia or non-alzheimer's dementia;
boolean
C0024485 (UMLS CUI [1])
C0040405 (UMLS CUI [2])
C0587081 (UMLS CUI [3])
human immunodeficiency virus; central nervous system; dementia; delirium; other; disease; score; hiv
Item
patient with significant clinically central nervous system illness other than ad (e.g. parkinson's disease, human immunodeficiency virus (hiv) induced dementia, hachinski ischaemic score (his) >4) or dementia complicated by other organic disease or delirium;
boolean
C0007682 (UMLS CUI [1])
alzheimer's disease; mental disorders; psychosis; other; current; severe; dsm-iv; stress; axis; post
Item
patient with a severe or uncontrolled diagnostic and statistical manual of mental disorders (dsm-iv) axis i disorder other than alzheimer's disease, including amnestic disorders, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, or post-traumatic stress disorder;
boolean
C0004936 (UMLS CUI [1])
stroke; trauma; event; last; from
Item
patient suffering from cerebral disturbances following a stroke or a cerebral trauma (if the event occurred within the last 6 months);
boolean
C0038454 (UMLS CUI [1,1])
C0234387 (UMLS CUI [1,2])
C0018674 (UMLS CUI [2,1])
C0234387 (UMLS CUI [2,2])
history of hypersensitivity to mistletoe; drugs; study
Item
patient with a history of hypersensitivity to study drugs;
boolean
C0013182 (UMLS CUI [1])
medical condition; adverse event; cardiovascular; investigator; not limited; evidence of; hematologic; neurologic; clinical; disease; hepatic; course; renal
Item
patient who has a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine (e.g., addison's disease), immune, neurologic, or hematologic disease as determined by the clinical judgment of the investigator;
boolean
C3843040 (UMLS CUI [1])
study; last
Item
participation in any research study within the last 30 days;
boolean
C0008976 (UMLS CUI [1])
current alcohol or drug abuse; investigator
Item
patient with significant alcohol or drug abuse as judged by the investigator.
boolean
C0237123 (UMLS CUI [1])
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