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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00265148 |
This is a placebo-controlled study evaluating the effects of rosiglitazone on functional brain activity and cognition in patients with mild to moderate Alzheimer's Disease (AD).
Condition | Intervention | Phase |
---|---|---|
Alzheimer's Disease |
Drug: rosiglitazone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets) on Cerebral Glucose Utilization and Cognition in Subjects With Mild to Moderate Alzheimer's Disease (AD) |
Estimated Enrollment: | 80 |
Study Start Date: | May 2004 |
Study Completion Date: | July 2008 |
Ages Eligible for Study: | 50 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Is aged >/= 50 to </= 85 years Prior and current use of medication corresponds with criteria listed in Appendix 3.
Exclusion criteria:
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 the definitions below). Significant ECG abnormalities for the purposes of this study. Detection of any of the following abnormalities renders the subject ineligible for the study: 1. ECG heart rate <50 and >100 bpm 2. Any previously unrecognised sustained or paroxysmal arrhythmia requiring further intervention e.g. anticoagulation, cardioversion, anti-arrhythmic agent, further investigation etc. 3. PR interval >0.3 s, 2nd or 3rd degree heart block, symptomatic bifascicular block, trifascicular block. 4. Multifocal ventricular ectopy. 5. Ventricular bigemini or couplets, triplets etc. ECG abnormalities permitted at entry to this study. A subject will not be rendered ineligible by the presence of any of the following abnormalities: 1. AF with a heart rate <=90 in subjects receiving appropriate anti-platelet or anticoagulant therapy. 2. 1st degree heart block (PR<=0.3 s). 3. Subjects with a paced rhythm (further information required if subject has an implantable Cardiac Defibrillator). 4. Atrial ectopic beats. 5. Unifocal ventricular ectopic beats. 6. Left or right bundle branch block. 7. Asymptomatice bifascicular block. 8. Left ventricular hypertrophy. 9. Q waves present suggesting previous MI. 10. Repolarisation abnormalities History of new cardiovascular event within 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 stenting) scheduled.
Significant peripheral oedema at the time of screening as assessed by Clinical Evaluation of Oedema and/or Signs of Congestive Heart Failure (Appendix 14)
Systolic blood pressure >165 mmHg or diastolic blood pressure >95 mmHG whilst receiving optimal antihypertensive therapy according to local practice.
Clinically significant anaemia (i.e.haemoglobin <11g/dL for males or <10 g/dL for females) or presence of haemoglobinopathies which would prevent accurate assessment of HbA1c.
Renal dysfunction, defined as creatinine clearance <30 ml/min (calculated from serum creatinine using the Cockcroft-Gault formula, See Appendix 10).
ALT, AST, total bilirubin, or alkaline phosphatase >2.5 times the upper limit of normal laboratory range, or history of severe hepatobiliary disease (e.g. hepatitis B or C, or cirrhosis (Childs-Pugh classes B/C)) without enzyme elevation.
any clinically relevant abnormality, medical or psychiatric condition, which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study.
History of alcohol abuse, or of drug abuse within the past 6 months (or has tested positive for drugs of abuse at screening).
Subject is unable (with assistance, if appropriate) to take study medication as prescribed throughout the study.
Subject is an immediate family member or employee of the participating investigator or of any of the participating site staff.
Shows any neurological abnormality by MRI, which in the opinion of the Principal Investigator would introduce additional risk factors, study procedures or effect endpoint data. MRI scanning will only be conducted on subjects who satisfy all other eligibility criteria.
Use of tacrine within 30 days prior to the screening visit.
United States, Arizona | |
GSK Investigational Site | |
Scottsdale, Arizona, United States, 85259 | |
GSK Investigational Site | |
Sun City, Arizona, United States, 85351 | |
GSK Investigational Site | |
Litchfield Park, Arizona, United States, 85340 | |
GSK Investigational Site | |
Phoenix, Arizona, United States, 85006 | |
GSK Investigational Site | |
Tucson, Arizona, United States, 85724 | |
United States, Massachusetts | |
GSK Investigational Site | |
Belmont, Massachusetts, United States, 02478 | |
United States, Michigan | |
GSK Investigational Site | |
Ann Arbor, Michigan, United States, 48109 | |
United States, North Carolina | |
GSK Investigational Site | |
Durham, North Carolina, United States, 27705 | |
Canada, Quebec | |
GSK Investigational Site | |
Montreal, Quebec, Canada, H3T 1E2 | |
GSK Investigational Site | |
Montreal, Quebec, Canada, H4H 1R3 | |
United Kingdom | |
GSK Investigational Site | |
Swindon, United Kingdom, SN1 4HZ | |
GSK Investigational Site | |
Liverpool, United Kingdom, L9 7LJ | |
GSK Investigational Site | |
West End, Southampton, United Kingdom, SO30 3JB | |
GSK Investigational Site | |
Manchester, United Kingdom, M20 3LJ |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | BRL-49653/461 |
Study First Received: | December 12, 2005 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00265148 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Alzheimer's Disease positron emission tomography (PET) rosiglitazone cerebral glucose metabolism cognition |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases Neurodegenerative Diseases |
Brain Diseases Dementia Rosiglitazone Cognition Disorders Delirium |
Hypoglycemic Agents Physiological Effects of Drugs Nervous System Diseases Tauopathies Pharmacologic Actions |