Screening and Visit 10 Eligibility Criteria Mild Alzheimer's Disease to Assess the of Extended Release Formulation of Rosiglitazone NCT00688207 / GSK-AVA109941

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StudyEvent: ODM
1. Screening and Visit 10 Eligibility Criteria Mild Alzheimer's Disease to Assess the of Extended Release Formulation of Rosiglitazone NCT00688207 / GSK-AVA109941

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

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.

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-ADRDA3 criteria for at least 3 months (Appendix 1 of the protocol). (1)

CL Item

Subject has mild Alzheimer´s disease as defined by a MMSE score 18 to 26 inclusive at screening. (2)

CL Item

Hachinski Ischemia Score <4 at screening (Appendix 2 of the Protocol). (3)

CL Item

Subjects aged >50 and <90 years. (4)

CL Item

Subject has not taken an approved Alzheimer´s therapy in the last 30 days. (5)

CL Item

Current use of medication is in accordance with the criteria listed in Section 9.1). (6)

CL Item

Female subjects must be post-menopausal (i.e. >1 year without menstrual period), surgically sterile, or agree to use adequate method of contraception (Append the GSK List of Highly Effective Methods for Avoidance of Pregnancy in Women of Childbearing Potential) for the duration of the study. Female subjects who are pre-menopausal or who have been post-menopausal for <1 year must undertake pregnant testing at screening, which must be negative. (More than one pregnancy test may be required (i.e., when the time period between enrollment and study treatment is >7 days). (7)

CL Item

Brain CT or MRI scan performed within the past 12 months or at screening, showing no evidence of any other potential cause of dementia other than Alzheimer´s disease. (8)

CL Item

Neurological exam without focal changes (excluding changes attributable to AD or peripheral trauma). (9)

CL Item

Subjects who live with or who have a regular caregiver who is willing to attend all visits, oversee the subject´s compliance with protocol specified procedures and study medication, and who is willing to report on subject´s status. (10)

CL Item

Subject has provided full written informed consent prior to the performance of any protocol-specified procedure. (11)

CL Item

Subjects considered for enrollment must have a QTc (either QTc B (Bazett´s correction) or QTc F (Fredericia´s correction)) <450msec at the screening Visit, with the exception of subjects with bundle branch block (for whom either QTc B or QTc F must be <480msec). (12)

CL Item

Since the subjects suffer from a neurodegenerative disease, subjects will only be enrolled into the study if they are able to realize the character, the implications and the importance of the clinical trial and to act accordingly. (13)

Exclusion Criteria

Item Group

Exclusion Criteria

C0680251 (UMLS CUI-1)

Exclusion Criteria

Item

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

CL Item

Diagnosis of possible, probable, or definite vascular dementia in accordance with NINDS-AIREN6 criteria (Appendix 3 of the Protocol). (1)

CL Item

History or evidence of any other CNS disorder that could be interpreted as a cause of dementia: e.g. cerebrovascular disease (stroke, hemorrhage), structural abnormality, epilepsy, infectious or inflammatory/demylinating CNS conditions, Parkinson´s disease. (2)

CL Item

Evidence of the following disorders: current vitamin B12 deficiency, positive syphilis serology or active thyroid dysfunction (particularly that suggestive of hypothyroidism), including abnormally high or low serum levels of thyroid stimulating hormone (TSH) that is clinically significant in the opinion of the investigator. (3)

CL Item

History of Type 1 diabetes mellitus or secondary diabetes mellitus. (4)

CL Item

Type 2 diabetes mellitus where the subject is being treated with insulin, a PPARyagonist, or an insulin secretagogue (e.g. a sulfonylurea or glitinide). (5)

CL Item

Any patient with an HbA1c >8.5% (See Section 7.2.1 for Safety Measures for Enrolled Subjects with Type 2 Diabetes Mellitus). (6)

CL Item

History or clinical/laboratory evidence congestive heart failure defined by the New Yorh Heart Association criteria (Clas I to IV cardiac status) (Appendix 4). (7)

CL Item

History of cardiovascular event within the last 6months (i.e. intervention, percutaneous coronary intervention, vascular surgery, acute coronary syndrome (non Q-wave myocardial infarction, Q-wave myocardial infarction, unstable anging) or significant arrhythmia, or major intervention (e.g. cardiac surgery or angiography plus stenting) scheduled). (8)

CL Item

History of significant psychiatric illness such as schizophrenia or bipolar affective disorder that in the opinion of the Investigator would interfere with the participation in the study, major depressive disorder (according to DSM-IV) in the past year, or current active depression requiring initiation of treatment. (9)

CL 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, which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study. (10)

CL Item

Clinically significant peripheral oedema at the time of screening. (11)

CL Item

Current or recent drug or alcohol abuse or dependence (defined by DSM-IV criteria for substance-related disorders), or recent or remote history of the same if that could be a contributing factor to the dementia. (12)

CL Item

Systolic blood pressure >165 or <190 mmHg or diastolic blood pressure >95 or <60 mmHg at the time of screening (13)

CL Item

Clinically significant anaemia (i.e. haemoglobin <11g/dL for males or <10g/dL for females) (14)

CL Item

Patients with GFR <50ml/min (assessed by Cockcroft-Gault method). (15)

CL Item

ALT, AST or alkaline phosphatase values >2.5 times the upper limit of normal, total bilirubin values >1.5 times the upper limit of normal, or history of severe hepatobiliary disease (e.g. hepatitis B or C, or cirrhosis, Child-Pugh Class B/C) (16)

CL Item

History of a bone marrow transplant. (17)

CL Item

Positive hepatitis B virus, hepatitis C virus or HIV test at screening. (18)

CL Item

Subject is unable (with assistance, if appropriate) to take study medication or is at risk of non-compliance with study procedures. (19)

CL Item

Subjects with hypersensitivity to rosiglitazone, diabetic ketoacidosis or diabetic precoma. (20)

CL Item

In View of the disease, subjects who have been committed to an institution by way of official or judicial order will be excluded from the study. (21)

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Screening and Visit 10 Eligibility Criteria Mild Alzheimer's Disease to Assess the of Extended Release Formulation of Rosiglitazone NCT00688207 / GSK-AVA109941