Feasibility Study in Subjects With Mild to Moderate Alzheimer's Disease

Inclusion Criteria

• Meets criteria for mild-to-moderate AD with Mini-Mental State Examination (MMSE) score of 14 through 26
• Clinical Dementia Rating = 0.5 to 2.0
• Modified Hachinski less than or equal to 4
• A clinical diagnosis of AD per NINCDS-ADRDA criteria
• Washout of psychoactive medication (other than anti-depressants): at least 4 weeks prior to baseline
• Stability of all permitted medications for 4-12 weeks prior to baseline
• Visual and auditory acuity adequate for neuropsychological testing
• Home monitoring available for supervision of medications

Exclusion Criteria

• Unstable diabetes or insulin use
• Unable to participate in FDG-PET scanning
• Inability to undergo a clinical MRI of the brain
• Diagnosis of significant neurological/psychiatric disease other than AD
• History of moderate or severe congestive heart failure, NYHA class III or IV, within 12 months prior to baseline.
• Previous cardiovascular event within the past 6 months prior to baseline
• Subject is pregnant, or lactating.
• ALT and/or AST levels that are twice the upper limit of normal; bilirubin levels that exceed 2 mg/dL; serum creatinine >1.5 mg/dL in men or > 1.4 mg/dL in women.
• Current or history of severe or unstable disorder (medical or psychiatric) requiring treatment that may make the subject unlikely to complete the study.
• Current use of fluvoxamine.
• Current unstable use of warfarin.
• Current use (within 30 days of baseline, visit 2) of certain highly protein-bound medications
• Malignancy within the last 5 years (other than non-melanoma skin cancer, stable, non-progressive prostate cancer not requiring treatment or in situ cervical cancer).
• Known history of HIV, hepatitis B, or hepatitis C.
• Blood pressure greater than 160/100 mmHg.
• Known or suspected intolerance or hypersensitivity to the study drugs, closely related compounds, or any of their stated ingredients.
• History of alcohol, drug abuse or dependence (except nicotine dependence) within 2 years.
• Investigational amyloid lowering therapies use within two months prior to baseline
• Have participated in any other investigational study or received an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to baseline
• Any surgical or medical condition which may significantly alter the absorption of any drug substance
• Resides in hospital or moderate to high dependency continuous care facility.
• Non ambulatory, or wheelchair-bound
• History of swallowing difficulties.
• Evidence of clinically relevant pathology that in the investigator's opinion could interfere with the study results or put the subject's safety at risk.

Expanded Access Extension :

Subjects must continue to meet the main study inclusion/exclusion criteria to insure continued safety to continue on a 6 months study extension