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ID
21026
Description
A 24 week double-blind, randomised, placebo-controlled, parallel-group dose-ranging 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: AVA100193, Sponsor: GSK Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00334568?term=NCT00334568&rank=1
Link
https://clinicaltrials.gov/ct2/show/NCT00334568?term=NCT00334568&rank=1
Keywords
Versions (1)
- 4/4/17 4/4/17 -
Uploaded on
April 4, 2017
DOI
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License
Creative Commons BY-NC 3.0
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Inclusion And Exclusion Criteria Effects Of Rosiglitazone (Extended Release Tablets) On Cerebral Glucose Utilisation And Cognition Alzheimers Disease NCT00334568 / GSK-AVA100193
Inclusion And Exclusion Criteria Effects Of Rosiglitazone (Extended Release Tablets) On Cerebral Glucose Utilisation And Cognition Alzheimers Disease NCT00334568 / GSK-AVA100193
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Inclusion And Exclusion Criteria Effects Of Rosiglitazone (Extended Release Tablets) On Cerebral Glucose Utilisation And Cognition Alzheimers Disease NCT00334568 / GSK-AVA100193
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Entry criteria
Item
Did the subject meet all the entry criteria? If No, check all boxes corresponding to violations of any inclusion/exclusion criteria. Do NOT enter the subject into the study if this failed any inclusion or exclusion criteria below. INELIGIBLE SUBJECTS ONLY Telephone the IVRS system to report the subject as a screening failure.
boolean
C1516637 (UMLS CUI [1])
Item
Check the boxes corresponding to any of the inclusion criteria the subject failed.
integer
C1512693 (UMLS CUI [1])
Code List
Check the boxes corresponding to any of the inclusion criteria the subject failed.
CL Item
Male or female subject with a clinical diagnosis of probable Alzheimer´s disease in accordance with NINCDS-ADRDA criteria. (Subjects with a clinical diagnosis of possible Alzheimer´s disease are not eligible.) (1)
CL Item
Subject has mild to moderate Alzheimer´s disease with MMSE score 16-26 inclusive at screening. (2)
CL Item
Age <50 and >85 years. (3)
CL Item
Prior and current medication is in accordance with the criteria on facing page. (4)
CL Item
Female subject must be post-menopausal (i.e. >6 months without menstrual period), surgically sterile, or if of child-bering potential, using effective contraceptive measures (oral contraceptives, Norplant, Depo-Provera, an intrauterine device (IUD), a diaphragm with spermicide or a condom with spermicide). Women of childbearing potential must use effective contraceptive measures for at least 1 month prior to screening, and should continue to use the same contraceptive method during the study and for 30 days after discontinuing study medication. (5)
CL Item
CT or MRI scan performed within the past 12 months or at screening, showing no evidence of tumor, other structural abnormality, or degenerative disease other than Alzheimer´s disease. (6)
CL Item
Neurological exam without focal changes (excluding changes attributable to peripheral trauma). (7)
CL Item
Subject has the ability to comply with procedures for cognitive and other testing. (8)
CL Item
Subject lives with a permanent caregiver who is willing to attend all visits, oversee the subject´s compliance with protocol-specified procedures and study medication, an report on subject´s status. (Subject´s living alone or in a nursing home are not eligible) (9)
CL 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. (10)
CL Item
Caregiver has provided full written informed consent on their own behalf prior to the performance of any protocol-specified procedure. (11)
Item
Check at the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.
integer
C0680251 (UMLS CUI [1])
Code List
Check at the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.
CL Item
History of Type 1 or Type 2 diabetes mellitus. (1)
CL Item
Fasting plasma glucose level >126mg/dL (>7.0mmol/L) or HbA1C >6.2%. (2)
CL Item
History or clinical/laboratory evidence of moderate to severe congestive heart failure defined by the New York Heart Association criteria (class II-IV). (3)
CL Item
Ejection fraction <40% determined by echocardiogram, or any other abnormality on echocardiography which in the view of investigator required further investigation or intervention, or significant abnormalities on screening ECG (in accordance with definitions on facing page). (4)
CL Item
History of new cardiovascular event wishing the last 6 months (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 stunting) scheduled). (5)
CL Item
History or clinical laboratory evidence of cerebrovascular disease (Strke, transient ischemic attack, hemorrhage), or diagnosis of possible, probable or definite vascular dementia in accordance with NINDS-AIREN criteria. (6)
Investigator Instructions
Item
A medically qualified Sub-investigator may sign this page; however, the Investigator remains accountable for CRF data.
text
C1442085 (UMLS CUI [1])
Invenstigator´s Signature
Item
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
text
C2346576 (UMLS CUI [1])
Investigator Name
Item
Investigator´s name (print)
text
C2826892 (UMLS CUI [1])
Date of Signature
Item
Date
date
C0807937 (UMLS CUI [1])