- Clinical diagnosis of probable AD with supportive brain imaging documentation
- Have existing neuropsychiatric symptoms as defined by a score equal or greater than 10
on the NPI at screening, arising from item scores equal or greater than 2 (frequency X
severity) on at least 2 domains.
- Has been on donepezil (stable dose of 5 mg or 10 mg) for at least four months, with no
intent to change such for the duration of the study.
- Demonstrate extreme agitation, physical aggression or violence to themselves, their
caregiver, or others, and/or an inability to complete the ADAS-cog assessment at
- Have major structural brain disease other than Alzheimer's Disease
- Other severe acute or chronical medical or psychiatric condition or laboratory