1. Signed and dated written informed consent obtained from the subject or the subject`s
legally authorized representative (LAR) or next of kin (if applicable), in accordance
with the local regulations. The subject`s caregiver must also consent to participate
in the study.
2. Diagnosis of probable Alzheimer's Disease according to National Institute of
Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related
Disorders Association (NINCDS-ADRDA) criteria.
3. Men and postmenopausal or surgically sterile women aged from 50 to 90 inclusive.
Postmenopausal women must have had 12 months of spontaneous amenorrhea. Surgically
sterile women are defined as having a hysterectomy, bilateral ovariectomy
[oophorectomy], or bilateral tubal ligation. Men who are sexually active will need to
agree to use a form of contraception that is satisfactory as per the investigator.
4. Able to participate in all scheduled evaluations with a high probability of completing
all required procedures and neuropsychological tests.
1. Significant neurological disease other than Alzheimer's disease, which may affect
cognition (eg, epilepsy, Parkinson disease).
2. Current diagnosis of a major depressive disorder or other major psychiatric symptom
according to the criteria of Diagnostic and Statistical Manual of Mental Disorders,
Fourth Edition Text Version (DSM-IV-TR).
3. Current clinically significant systemic illness, which is likely to deteriorate or
affect the subject's safety, influence cognitive assessment or ability to complete the
4. Any clinically important deviation from normal limits in physical and neurological
examination, vital signs, on electrocardiogram (ECG) or clinical laboratory test
results that could compromise the study or be detrimental to the subject.