A phase II study of an oral medication developed to block the receptor for advanced glycation end products which damage nerve cells in the brain
The goal of this Phase II, double-blind, randomized, placebo-controlled study is to evaluate the efficacy of 18 months of treatment relative to placebo as well as to examine the safety and tolerability of 18 months of treatment with the intervention relative to placebo. The study will be conducted with participants with mild to moderate Alzheimer’s disease.
The study, which is being conducted by the Rush Alzheimer’s Disease Center (one of the 40 sites around the world), is sponsored and funded by Pfizer in cooperation with the Alzheimer’s Disease Cooperative Study Group.
Duration of the study is 18 months. Eligible participants will have a 33.3 percent chance of receiving the 5mg dose of the study medication, 33.3 percent chance of receiving the 20mg dose of the study medication, and a 33.3 percent chance of receiving placebo.
Each clinic visit will be a combination of all or some of the following: memory testing; neurological exams, blood, urine and/or spinal fluid collection; electrocardiograms (ECGs) as well as close monitoring for side effects that may occur with the administration of the vaccine.
There will be no cost to people who join the study. The study medication and all visits will be covered by the research study.
You may be eligible to participate in this study if you:
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Are at least 50 years of age
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Have a diagnosis of mild to moderate Alzheimer’s disease [a Mini-Mental State Examination (MMSE) Score between 14 and 26
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Are otherwise healthy and on stable doses of all medications for at least three months
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Do not have Type 1 or Type 2 Diabetes
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Speak English
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Have a friend or family member who will accompany the subject to all study visits
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via e-mail, please include the title of the study in your message.