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ID
17362
Beschreibung
NCT00334568/ GSK-AVA100193: M.Alzheimer GSK A 24 week double-blind, randomized, placebo-controlled, parallel-group dose-raging study to investigate the effects of rosiglitazone (extended release tablets) on cognition in subjects with mild to moderate Alzheimer´s disease. Medicine: rosiglitazone, Condition: Alzheimer´s Disease, Phase: 2, Clinical Study ID: AVA 100193, Sponsor: GSK This ODM contains Book 1/Visit 1.
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Hochgeladen am
8. September 2016
DOI
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Lizenz
Creative Commons BY-NC 3.0
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NCT00334568/ GSK-AVA100193: M.Alzheimer GSK
NCT00334568/ GSK-AVA100193: M.Alzheimer GSK
- StudyEvent: ODM
Ähnliche Modelle
NCT00334568/ GSK-AVA100193: M.Alzheimer GSK
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Subject Identifier
Item
Subject Identifier
text
Visit Date
Item
Visit Date
date
Date of Birth
Item
Date of Birth
date
CL Item
Male (1)
CL Item
Female (2)
CL Item
Arabic/North Africa (1)
CL Item
Black (2)
CL Item
East & South East Asian (3)
CL Item
Japanese (4)
CL Item
South Asian (5)
CL Item
White/Caucasian (6)
CL Item
Other (7)
Date of first symptoms
Item
Date of first symptoms
date
Date of diagnosis of probable AD
Item
Date of diagnosis of probable AD
date
Has there been a significant worsening in the past 6 month?
Item
Has there been a significant worsening in the past 6 month?
boolean
Item
Is there any family history of AD? Parents/sibling/child?
text
Code List
Is there any family history of AD? Parents/sibling/child?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Height
Item
Height
integer
Weight
Item
Weight
float
Blood pressure (See Description)
Item
Blood pressure: Systolic
integer
Blood pressure
Item
Blood pressure: Diastolic
integer
Heart rate
Item
Heart rate
integer
How many full years of education did the subject complete? (include primary to post-university education)
Item
How many full years of education did the subject complete? (include primary to post-university education)
integer
Item
What is the subject´s history of tobacco use (include all tobacco products)?
text
Code List
What is the subject´s history of tobacco use (include all tobacco products)?
CL Item
Never smoked (1)
CL Item
Current smoker (2)
CL Item
Former smoker (3)
If former smoker: When did the subject last smoke?
Item
If former smoker: When did the subject last smoke?
date
If current or former smoker: number of cigarettes smoked per day
Item
If current or former smoker: number of cigarettes smoked per day
integer
If current or former smoker: Number of years during which the subject has smoked?
Item
If current or former smoker: Number of years during which the subject has smoked?
integer
Row number
Item
Row number
integer
Specific Condition
Item
Specific Condition
text
Current
Item
Current
boolean
Past
Item
Past
boolean
Item Group
Prior and Concomitant Medications (See Description)
Drug Name
Item
Drug Name (Trade Name preferred)
text
Totally Daily Dose
Item
Totally Daily Dose
integer
Units
Item
Units (e.g mg)
text
Route
Item
Route
text
Reason for Medication
Item
Reason for Medication
text
Start Date
Item
Start Date
date
Stop Date
Item
Stop Date
date
Ongoing Medication
Item
Ongoing Medication
boolean
Item Group
Central Laboratory (Fasting Samples, See Description)
Date samples taken
Item
Date samples taken
date
Date of ECG
Item
Date of ECG
date
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (Assess eligibility and record abnormalities within the medical conditions item) (3)
Depression score
Item
Depression score
integer
MMSE score
Item
MMSE score
integer
Ejection fraction
Item
Ejection fraction
integer
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
Inclusion
Item
Male or female subject with a clinical diagnosis of probable (!) Alzheimer´s disease in accordance with NINCDS-ADRDA criteria. (Subject with a clinical diagnosis of possible Alzheimer´s disease are not eligible.)
boolean
Inclusion
Item
Subject has mild to moderate Alzheimer´s disease with MMSE score 16-26 inclusive at screening.
boolean
Inclusion
Item
Age 50 - 85 years.
boolean
Inclusion
Item
Prior and current medication is in accordance with the criteria on facing page.
boolean
Inclusion
Item
Female subjects must be post-menopausal (i.e > 6 month without menstrual period), surgically sterile, or if of child-bearing potential, using effective contraceptives measures (oral contraceptives, Norplant, Depo-Provera, an intra-uterine device (IUD), a diaphragm with spermicide or a condom with spermicide). Woman of childbearing potential must use effective contraceptive measures for at least one month prior to screening, and should continue to use the same contraceptive method during the study and for 30 days after discontinuing study medication.
boolean
Inclusion
Item
CT or MRI scan performed within the past 12 month or at screening, showing no evidence of tumor, other structural abnormality, or degenerative disease other than Alzheimer´s disease.
boolean
Inclusion
Item
Neurological exam without focal changes (excluding changes attributable to peripheral trauma).
boolean
Inclusion
Item
Subject has the ability to comply with procedures for cognitive and other testing.
boolean
Inclusion
Item
Subject lives with permanent caregiver who is willing wo attend all visits, oversees the subject´s compliance with protocol-specified procedures and study medication, and report on subject´s status. (Subjects living alone or in a nursing home are not eligible).
boolean
Inclusion
Item
Subject has provided full written informed consent prior to the performance of any protocol-specified procedure; or if unable to provide informed consent due to cognitive status, full written informed consent on behalf of the subject has been provided by a legally acceptable representative.
boolean
Inclusion
Item
Caregiver has provided full written informed consent on their own behalf prior to the performance of any protocol-specified procedure.
boolean
Exclusion
Item
History of Type I or Type II diabetes mellitus.
boolean
Exclusion
Item
Fasting plasma glucose level > 126 mg/dL (>7.0 mmol/L) or HbA 1c >6.2%
boolean
Exclusion
Item
History or clinical/laboratory evidence of moderate to severe congestive heart failure defined by the New York Heart Association criteria (class II-IV)
boolean
Exclusion
Item
Ejection fraction ≤ 40% determined by echocardiogram, or any other abnormality on echocardiography which in the view of the investigator required further investigation or intervention, or significant abnormalities on screening ECG (in accordance with definitions on facing page).
boolean
Exclusion
Item
Ejection fraction ≤ 40% determined by echocardiogram, or any other abnormality on echocardiography which in the view of the investigator required further investigation or intervention, or significant abnormalities on screening ECG (in accordance with definitions on facing page).
boolean
Exclusion
Item
History of new cardiovascular event within the last 6 month (i.e intervention, percutaneous coronary intervention, vascular surgery, acute coronary syndrome (non Q-wave myocardial infarction, Q-wave myocardial infarction, unstable angina) or significant arrhythmia; or major intervention (e.g cardiac surgery or angiography plus stenting) scheduled).
boolean
Exclusion
Item
History or clinical laboratory evidence of cerebrovascular disease (stroke, transient ischaemic attack, haemorrhage), or diagnosis of possible, probable or definite vascular dementia in accordance with NINDS-AIREN criteria.
boolean
Exclusion
Item
History or evidence of any other CNS disorder that could be interpreted as a cause of dementia: e.g structural abnormality, epilepsy, infectious or inflammatory/demyelinating CNS conditions, Parkinson´s disease.
boolean
Exclusion
Item
History of significant psychiatric illness such as schizophrenia or bipolar affective disorder, that in the opinion of the investigator would interfere with participation in the study, or current depression (score on Hospital Anxiety and Depression Scale (HADS) depression questions >7)
boolean
Exclusion
Item
Significant peripheral oedema at the time of screening.
boolean
Exclusion
Item
Systolic blood pressure > 165 mmHg or diastolic blood pressure > 95 mmHg whilst receiving optimal antihypertensive therapy according to local practice.
boolean
Exclusion
Item
Clinically significant anaemia (i.e. hemoglobin <11 g/dL for males or < 10 g/dL for females) or presence of haemoglobinopathies which would prevent accurate assessment of HbA 1c.
boolean
Exclusion
Item
Renal dysfunction, defined as creatinine clearance <30 ml/min (calculated from serum creatinine using the Cockcroft-Gault formula).
boolean
Exclusion
Item
ALT, AST, total bilirubin or alkaline phosphatase values > 2.5 times the upper limit of normal, or history of severe hepatobiliary disease (e.g hepatitis B or C, or cirrhosis).
boolean
Exclusion
Item
Fasting triglycerides > 12 mmol/L.
boolean
Exclusion
Item
Abnormal/positive result within the past 12 months or at screening for any of the following tests: vitamin B12, syphilis serology, thyroid stimulating hormone (TSH).
boolean
Exclusion
Item
History or presence of gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs, or any other clinically relevant abnormality, medical or psychiatric condition, which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study.
boolean
Exclusion
Item
Subject has given a blood donation of ≥ 450ml within the past 2 months.
boolean
Exclusion
Item
History of drug or alcohol abuse.
boolean
Exclusion
Item
Subject is unable (with assistance, if appropriate) to take study medication as prescribed throughout the study, has a history of non-compliance with prescribed medication, or is at risk of non-compliance with study medication or procedures.
boolean
Exclusion
Item
Subject is an immediate family member or employee of the participating investigator or of any of the participating site staff.
boolean
Investigator´s Signature (See Description)
Item
Investigator´s Signature (See Description)
text
Date
Item
Date
date
Investigator´s name (print)
Item
Investigator´s name (print)
text