Memory Loss with Agitation
1. Males and females 55 to 90 years of age (inclusive) at the time of informed consent.
2. Diagnosis of probable Alzheimer's disease according to the 2011 NIA-AA working groups critieria. Either outpatients or residentsa of an assisted living facility a skilled nuring home, a dementia unit, or any other type of facility providing long-term care.
3. MMSE score between 8 and 24 (inclusive) at Screening and Baseline.
4. Patients has clinically significant, moderate-to-severe agitation for at least 2 weeks prior to Screening that interferes with daily routine per the investigator's judgement.
5. Patients who require pharmacotherapy for the treatment of agitation per the Investigator's judgment after:
. An evaluation of reversible factors (eg, pain, infection, or polypharmacy), and
. A course of nonpharmacological interventions (eg, redirecting behavior, group activities, music therapy)
6. Diagnosis of agitation must meet the International Psychogeriatric Association (IPA) Provisional definition of agitation
7. NP1-AA total score (frequency x severity) must be > 4 at Screening and Baseline.
8. The patient must meet an additional predetermined blinded eligibility criterion.
9. The patient has stable cardiac, pulmonary, hepatic, and renal function per the Investigator's judgment
10. No clinically significant findings on the Screemomg ECG based on cemtra;review and on the Baseline predose ECG based on the machine read and Investigator's evaluation.
11. Women who are of childbearing potential and are sexually active must use an effective method of birth control for at least 1 month prior to the Baseline, during participation in the study, and for at least 30 days after the last dose of study drug.the following requirements must be met:
> Women who are childbreating potential must use 2 of the following precautions in order to minimize the risk of failure of I method of birth control : Vasectomy, tubal ligation, vaginal diaphragm, intrauterine device, birth control pills, birth control depot injection, birth control implant, or condom with spermicide or sponge with spermicide. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to study drug, or withdrawal are not acceptable methods of contraception.
Women who are sterile (ie, had an oophorectomy and/or hysterectomy), postmenopausal (defined as 12 consecutive months with no menses without an alternative medical cause), or practice true abstinence (when this method is in line with the preferred and usual lifestyle of the patient) are exempt from this requirement.
> Women who are lactating, pregnant, or plan to become pregnant are not eligible for participation in the study.
12. For restricted and prohibited concomitant medications, patients willing and able to meet all protocol requirements for duration of stability or washout prior to study entry and during the study (see Table 3 Restricted and Prohibited Concomitant Medications and Appendix 1 Prohibited Concomitatnt Medications).
13. Caregiver must be willing and able to comply with all study procedures, including adherence to administering study during and not administering any prohibited medications during the study. The caregiver must spend a minimum of 2 hours with the patient per day for at least 4 days per week to qualify as caregiver.
14. Patient/caregiver must be willing to sign and receive a copy of patient/caregiver informed consent form (ICF) after the nature and risks of study participation have been fully explained. Patient who are not capable of signing the ICF but are able to provide assent. or the patent's authorized representative agrees to participation (for patients unable to provide assent) are allowed.