ID

12902

Description

Long-term Safety and Efficacy of Galantamine in Alzheimer's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00304629

Link

https://clinicaltrials.gov/show/NCT00304629

Keywords

Versions (1)
  1. 1/5/16 1/5/16 -
Uploaded on

January 5, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Alzheimer Disease NCT00304629

English

Eligibility Alzheimer Disease NCT00304629

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have taken trial medication during the 24-month trial period of gal-int-8 and should be enrolled within 1 month after completion
Description

medication

Data type

boolean

Alias
UMLS CUI [1]
C0013227
patients and their primary caregiver give informed consent for the participation in the trial
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients must have remained in good health, as determined by medical history, complete physical examination and laboratory tests
Description

health status

Data type

boolean

Alias
UMLS CUI [1]
C0018759
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
if a patient developed, during the trial gal-int-8, symptoms of other neurological or psychiatric diseases that might contribute to dementia, the subject cannot be enrolled. this includes subjects developing neurodegenerative disorders such as parkinson's disease, pick's disease or huntington's chorea, or creutzfeldt-jacob disease, and subjects with cognitive impairment resulting from stroke, acute cerebral trauma, hypoxic cerebral damage, infection or primary or metastatic cerebral neoplasia
Description

dementia

Data type

boolean

Alias
UMLS CUI [1]
C0497327
subjects with the following co-existing medical conditions: a) any history of epilepsy or convulsions except for febrile convulsions during childhood b) peptic ulcer: if the ulcer is considered to be still "active", i.e., if treatment for this condition started <3 months ago or if treatment is not successful (symptoms still present), the subject is not eligible. c) clinically significant hepatic, renal, pulmonary, metabolic or endocrine disturbances
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
patients with current, clinically significant cardiovascular disease that would be expected to limit the subject's ability to complete a 12-month trial. the following would usually be considered clinically significant cardiovascular disease: a) unstable angina
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
angina or coronary artery disease that required a change in medication (anti-angina or digitalis) within the last 3 months b) decompensated congestive heart failure i.e. when symptoms occur in a subject on stable medication during rest or light exercise (nyha iii and iv). note: if the only signs of decompensation are pretibial or malleolar oedema and the exercise tolerance is still reasonable (absence of dyspnoea) the subject should not be excluded c) cardiac disease potentially resulting in syncope, near syncope or other alterations of mental status
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
in addition, the following conditions should lead to exclusion: atrial fibrillation without prophylactic treatment to prevent thromboembolic stroke, bradycardia <50 beats/min., atrioventricular block > first degree. d) severe mitral or aortic valvular disease e) hypotension or treatment for hypotension f) systolic blood pressure greater than 170 mmhg or diastolic blood pressure greater than 110 mmhg
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
patients using any agent for the treatment of dementia (approved, experimental, including over the counter agents), including, but not limited to nootropic agents, cholinomimetic agents, choline, oestrogens taken without medical need, chronic nsaids (30 consecutive days), vitamin e more than 30 iu daily, and deprenyl
Description

medication

Data type

boolean

Alias
UMLS CUI [1]
C0013227
conditions that could interfere with the absorption of the compound or with the evaluation of the disease
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
Back to the top of the page

Similar models

Eligibility Alzheimer Disease NCT00304629

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
medication
Item
patients must have taken trial medication during the 24-month trial period of gal-int-8 and should be enrolled within 1 month after completion
boolean
C0013227 (UMLS CUI [1])
informed consent
Item
patients and their primary caregiver give informed consent for the participation in the trial
boolean
C0021430 (UMLS CUI [1])
health status
Item
patients must have remained in good health, as determined by medical history, complete physical examination and laboratory tests
boolean
C0018759 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
dementia
Item
if a patient developed, during the trial gal-int-8, symptoms of other neurological or psychiatric diseases that might contribute to dementia, the subject cannot be enrolled. this includes subjects developing neurodegenerative disorders such as parkinson's disease, pick's disease or huntington's chorea, or creutzfeldt-jacob disease, and subjects with cognitive impairment resulting from stroke, acute cerebral trauma, hypoxic cerebral damage, infection or primary or metastatic cerebral neoplasia
boolean
C0497327 (UMLS CUI [1])
comorbidity
Item
subjects with the following co-existing medical conditions: a) any history of epilepsy or convulsions except for febrile convulsions during childhood b) peptic ulcer: if the ulcer is considered to be still "active", i.e., if treatment for this condition started <3 months ago or if treatment is not successful (symptoms still present), the subject is not eligible. c) clinically significant hepatic, renal, pulmonary, metabolic or endocrine disturbances
boolean
C0009488 (UMLS CUI [1])
comorbidity
Item
patients with current, clinically significant cardiovascular disease that would be expected to limit the subject's ability to complete a 12-month trial. the following would usually be considered clinically significant cardiovascular disease: a) unstable angina
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
comorbidity
Item
angina or coronary artery disease that required a change in medication (anti-angina or digitalis) within the last 3 months b) decompensated congestive heart failure i.e. when symptoms occur in a subject on stable medication during rest or light exercise (nyha iii and iv). note: if the only signs of decompensation are pretibial or malleolar oedema and the exercise tolerance is still reasonable (absence of dyspnoea) the subject should not be excluded c) cardiac disease potentially resulting in syncope, near syncope or other alterations of mental status
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
comorbidity
Item
in addition, the following conditions should lead to exclusion: atrial fibrillation without prophylactic treatment to prevent thromboembolic stroke, bradycardia <50 beats/min., atrioventricular block > first degree. d) severe mitral or aortic valvular disease e) hypotension or treatment for hypotension f) systolic blood pressure greater than 170 mmhg or diastolic blood pressure greater than 110 mmhg
boolean
C0009488 (UMLS CUI [1])
medication
Item
patients using any agent for the treatment of dementia (approved, experimental, including over the counter agents), including, but not limited to nootropic agents, cholinomimetic agents, choline, oestrogens taken without medical need, chronic nsaids (30 consecutive days), vitamin e more than 30 iu daily, and deprenyl
boolean
C0013227 (UMLS CUI [1])
comorbidity
Item
conditions that could interfere with the absorption of the compound or with the evaluation of the disease
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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