NOBLE is a clinical study to evaluate an investigational drug for patients with mild to moderate Alzheimer’s disease. Participants will receive the study drug or a placebo. During this study, if you are already taking medication for Alzheimer’s disease, you will probably continue to take it along with the study drug or placebo. The investigational drug may work by protecting brain cells which could result in improved memory. But, this has not been proven yet. We are doing this study to find out if this is true.

The study will enroll 450 patients with mild to moderate Alzheimer’s disease at many research sites across the United States. Total participation time is about 14 months, which includes screening, about one year of study treatment, and follow up to check safety.

You will be screened to see if you are eligible to participate. Screening includes tests like EKG, blood and urine exams, physical examination, and cognitive testing. Upon enrollment in the study, you will have a 1/3 chance of receiving the low dose of study drug, the high dose of study drug or placebo. Study participants will be seen by researchers every 4 weeks for the first 3 months, then every 6 to 8 weeks for the next 9 months, with a follow up visit 4 weeks later. Cognitive and physical evaluations and blood testing will be conducted at each visit. An MRI scan of the brain will be done at the beginning and end of the study.

Regularly scheduled physician visits are not disrupted by the study. Primary care physicians will be kept informed of your progress and laboratory results. You will also receive regular health assessments by health care professionals who specialize in Alzheimer’s disease.

Your participation is critical for developing effective treatments. People who have Alzheimer’s disease are urgently needed to aid researchers in finding new approaches

Selected eligibility criteria:

• Women and men aged 55-85 years old with mild to moderate Alzheimer’s Disease
• Receiving donepezil (Aricept®) or rivastigmine (Exelon® Patch) treatment for at least six months
• Living in the community (not nursing homes)
• Have a study partner that has regular contact with you about 10 hours per week and who will come to study visits with you
• Weight of no more than 220 pounds

This study is sponsored by Toyama Chemical Co., Ltd and is being conducted by the Alzheimer’s Disease Cooperative Study (ADCS).