Inclusion Criteria includes:
Male or female subjects aged 50-90
MMSE score greater than or equal to 22
Body mass index (BMI) greater than 17 and less than 35 at Screening.
Have an identified study partner (defined as a person able to support the subject for the duration of the study and who spends at least 8 hours per week with the subject). The study partner must provide separate written informed consent. In addition, this person must be willing and able to provide follow-up information on the subject throughout the course of the study.
Exclusion Criteria includes:
1. Females who are breastfeeding or pregnant
2. Females of childbearing potential who:
-Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:
-total abstinence (if it is their preferred and usual lifestyle)
-an intrauterine device or intrauterine hormone-releasing system (IUS)
-a contraceptive implant
-an oral contraceptive (with additional barrier method) (Subject must be on a stable dose of the same oral contraceptive product for at least 28 days before dosing and throughout the study and for 28 days after study drug discontinuation.)
-have a vasectomized partner with confirmed azoospermia
-do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation
-for sites outside of the EU, it is permissible that if a highly effective method of contraception is not appropriate or acceptable method of contraception, ie, double-barrier methods of contraception such as latex or synthetic condom plus diaphragm or cervical/vault cap with spermicide
3. Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the subject's AD.
4. History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of Screening.
5. Any psychiatric diagnosis or symptoms, (eg, hallucinations, major depression, or delusions) that could interfere with study procedures in the subject.
6. GDS score greater than or equal to 8 at Screening.