A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer’s disease. (REFLECT-1)
- Conditions
- G309-G309 Alzheimer´s disease, unspecifiedAlzheimer´s disease, unspecified
- Registration Number
- PER-002-07
- Lead Sponsor
- GLAXOSMITHKLINE PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
1. Male or female patient with a clinical diagnosis of probable Alzheimer´s disease.
2. The patient has mild to moderate Alzheimer´s disease.
3. Score ≤ 4 on the Hachinski Scale for Ischemia.
4. Age ≥ 50 and ≤ 90 years.
5. The patient must not have taken any approved therapy for Alzheimer´s disease during the past 30 days.
6. The patient has not had a prior history of hypersensitivity or intolerance to acetylcholinesterase inhibitors.
7. The use of medication is in accordance with the enumerated criteria of the Permitted Medications.
8. Female patients should be postmenopausal, surgically sterile, or accept an appropriate contraceptive method for the duration of the study.
9. Computed tomography or magnetic resonance imaging studies of the brain within the last 12 months or during the Screening, demonstrating the absence of evidence of some other potential cause for dementia apart from Alzheimer´s disease.
10. Neurological examination without focal changes.
11. The patient is able to comply with procedures for cognitive and other evaluations.
12. The patient lives with a person who attends him on a regular basis, who agrees to attend all visits, to supervise the patient´s compliance with the procedures and with the study medication specified by the protocol; and to report the patient´s condition.
13. The patient has given full written consent in writing before any procedure is performed.
14. The person treating the patient has given their full informed consent in writing before any procedure is performed.
1. A diagnosis of possible, probable or definite vascular dementia.
2. History or evidence of some other disorder in the central nervous system that could be interpreted as a cause of dementia.
3. Evidence of the following disorders: current vitamin B12 deficiency, positive serology for syphilis or active thyroid dysfunction, including abnormally high or low serum levels of thyroid stimulating hormone that are clinically significant.
4. History of type 1 diabetes mellitus or secondary diabetes mellitus.
5. Type 2 diabetes mellitus where the patient has been treated with insulin, with an agonist of the Activated Gamma Receptors for the Peroxisome Proliferator (PPARy), or with an insulin secretagogue.
6. Any patient with a level ≥ 8.5% in HbA1c.
7. History of clinical / laboratory evidence of congestive heart failure.
8. History of a cardiovascular event within the last 6 months.
9. History of a significant psychiatric illness during the last year.
10. History or presence in gastrointestinal, hepatic or renal disease, or any other condition that is known to interfere with the absorption, distribution, metabolism or excretion of drugs, or any other clinically relevant abnormality, any medical or psychiatric condition; which, make the patient inappropriate for inclusion in the study.
11. Clinically significant peripheral edema at the time of selection.
12. Current or recent drug or alcohol abuse or dependence, or recent or remote history of the same condition, which may be a contributing factor to dementia.
13. Systolic blood pressure> 165 or <90 mm Hg, or diastolic blood pressure> 95 or <60 mm Hg at the time of selection.
14. Clinically significant anemia.
15. Abnormal results in renal function tests.
16. Values of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase> 2.5 times the upper limit of normal; total bilirubin values> 1.5 times the upper limit of normality, or history of severe hepatobiliary disease.
17. History of having undergone a bone marrow transplant.
18. The patient is unable to take the study medication as prescribed or is at risk of not meeting the medication or study procedures.
19. The patient is an immediate member of the participating Researcher´s family, or of any member of staff participating in the headquarters, or is an employee of GlaxoSmithKline (GSK).
20. In France, that the patient is not affiliated or beneficiary of any category of social security.
21. The French patient has participated in any study where a research drug was used during the previous 30 days or for 5 half-lives.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method