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ID
21906
Description
The present pharmacokinetic study is designed to assess the pharmacokinetics of RSG XR as monotherapy in patients with mild Alzheimer's disease (AD) as such information will not be obtained from the current phase III trials . The study aims to enroll fourteen patients (seven of each APOE genotype). Each patient will receive a single oral dose of 4mg of RSG XR in the morning under fasted conditions and PK samples will be taken up to 36h. GSK Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00688207?term=NCT00688207&rank=1
Link
https://clinicaltrials.gov/ct2/show/NCT00688207?term=NCT00688207&rank=1
Keywords
Versions (2)
- 5/8/17 5/8/17 -
- 5/8/17 5/8/17 -
Uploaded on
May 8, 2017
DOI
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License
Creative Commons BY-NC 3.0
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Screening Eligibility Criteria Mild Alzheimer''s Disease to Assess the of Extended Release Formulation of Rosiglitazone NCT00688207 / GSK-AVA109941
Screening Eligibility Criteria Mild Alzheimer''s Disease to Assess the of Extended Release Formulation of Rosiglitazone NCT00688207 / GSK-AVA109941
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Screening Eligibility Criteria Mild Alzheimer''s Disease to Assess the of Extended Release Formulation of Rosiglitazone NCT00688207 / GSK-AVA109941
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.
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-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)
Item
Check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.
integer
C0680251 (UMLS CUI [1])
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)