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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1. Inclusion And Exclusion Criteria Effects Of Rosiglitazone (Extended Release Tablets) On Cerebral Glucose Utilisation And Cognition Alzheimers Disease NCT00334568 / GSK-AVA100193

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de datos

Alias

Eligibility Question

Item Group

Eligibility Question

C1516637 (UMLS CUI-1)

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])

Inclusion Criteria

Item Group

Inclusion Criteria

C1512693 (UMLS CUI-1)

Inclusion

Item

Check the boxes corresponding to any of the inclusion criteria the subject failed.

integer

C1512693 (UMLS CUI [1])

Inclusion

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)

Exclusion Criteria

Item Group

Exclusion Criteria

C0680251 (UMLS CUI-1)

Exclusion Criteria

Item

Check at the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.

integer

C0680251 (UMLS CUI [1])

Exclusion Criteria

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)

Invenstigator´s Signature

Item Group

Invenstigator´s Signature

C2346576 (UMLS CUI-1)

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])

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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