Qualifications for this Study

Inclusion Criteria:

• Male or female 50 years of age or older with diagnosis of probable AD
  
• Females must be surgically sterile or post menopausal for at least 2 years
  
• Mini Mental State Exam (MMSE) score between 14-26 (inclusive) at screening
  
• Rosen Modified Hachinski Ischemia Score less than or equal to 4
  
• Participants must be receiving acetylcholinesterase inhibitors on a stable dose for at least 4 months prior to randomization and must agree to remain on a stable dose for the remainder of the study period
  
• Participants receiving memantine must have taken this medication for at least 4 months prior to randomization and must agree not to change the dose during the study period
  
• Participants receiving behavioral medications (including antidepressants, antipsychotics and anxiolytics) must be on stable doses for at least 4 weeks prior to randomization
  
• Must be in good health with no serious or unstable disease within the past 3 months
  
• Able to ingest oral medications
  
• The participant must have regular contact (at least 3 days a week) with a reliable study partner who will facilitate the participant’s full participation in the study

Exclusion Criteria:

• Current evidence or history of neurological, psychiatric and any other illness that could contribute to dementia or any form of dementia other than AD
  
• Known history of familial AD or any evidence for early onset AD known or possibly associated with genetic mutations; individuals from families with late onset AD with 2 or more affected family members may participate
  
• History of clinically significant stroke or significant cerebrovascular disease
  
• Poorly controlled hypertension or a history of either a myocardial infarction or signs or symptoms of unstable coronary artery disease within the last 6 months
  
• Pulmonary disease or evidence of clinically significant pulmonary symptoms
  
• History of cancer within the last 5 years (treated basal cell or squamous cell carcinoma of the skin allowed, stable localized prostate cancer not requiring treatment allowed)
  
• Evidence or history of clinically significant allergic reactions, including severe drug allergies (such as resulting in dyspnea or severe rash)
  
• Weight less than 40 kg or greater than 100 kg (and BMI greater than 30 kg/m2) within past two years
  
• Evidence or history of diabetes mellitus Type 1 or Type 2, or participants on insulin or oral hypoglycemics
  
• Clinically significant hepatic or renal disease
  
• History or symptoms of autoimmune disorders
  
• Use of another investigational drug within 90 days of the study screening visit or plans to take another investigational drug within 90 days of study completion; participants with prior exposure to active immunotherapy for AD are excluded from participation in this study; participants with prior exposure to passive immunotherapy for AD may not be screened in the current study until 6 months after the last dose of passive immunotherapy has been given

Prohibited Medications:

• Drugs that may prolong the QT interval (some may be allowed with limited use and low dose only--check with principal investigator)
  
• Drugs known to be potent CYP 3A4 inhibitors/inducers
  
• Any use of steroid treatment (topical application to the skin is allowed)
  
• Chronic use (daily use of more than 3 out of 4 weeks) of nonsteroidal anti-inflammatory drugs (NSAIDs) including Cox 2 selective NSAIDs; spontaneous or occasional use of NSAIDs is allowed
  
• Insulin and oral hypoglycemics
  

Study Description

Evidence suggests Alzheimer’s disease may be caused by amyloid plaque deposits and tangles in the brain which lead to cognitive decline, memory loss and behavioral changes. Many proteins surround the amyloid plaques in Alzheimer’s disease patients. One of the proteins, Receptor for Advanced Glycation Endpoints, called RAGE for short, binds to amyloid and may promote inflammation and lead to nerve cell damage.

Researchers found that by inhibiting the RAGE protein, plaque formation could be reduced in animal models. The experimental drug was developed as a RAGE inhibitor (RI). This is a novel pathway for trying to treat Alzheimer’s disease. Some participants will be invited to volunteer for an important sub-study, which includes magnetic resonance imaging of the brain and a lumbar puncture, to examine cerebrospinal fluid for changes in amyloid beta protein and other markers.

The study will recruit nearly 399 volunteers at 44 U.S. research sites. Each participant will be evaluated in the clinic 12 times over the course of 21 months. Participants will be randomly assigned to one of three groups: two groups will receive different doses of the experimental drug and the third group will receive a placebo (an identical inactive pill).

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