A Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects With Alzheimer's Disease
Condition: Agitation and Aggression in Alzheimer's Disease
MeSH terms: Alzheimer Disease; Psychomotor Agitation; Aggression
Intervention: Pimavanserin
Intervention description: Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth, OR Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth
Intervention MeSH terms: Pimavanserin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 79.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      To evaluate the safety and tolerability of pimavanserin over 52 weeks of treatment in
      subjects with probable AD who have symptoms of agitation and aggression
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must complete the Week 12 visit in Study ACP-103-032 while continuing to take his/her
             assigned dose of blinded study drug

          2. Can understand the nature of the trial and protocol requirements and provide signed
             informed consent

               -  from patient, if deemed competent to provide consent

               -  from an appropriate person (e.g. patient's Legally Authorized Representative
                  (LAR) with the patient's assent) if patient is deemed not competent to provide
                  informed consent.

          3. Lives at home or in an assisted living or care facility (but has the capacity to visit
             the clinic as an outpatient)

          4. Has a designated study partner/caregiver who is in contact with the patient at least 3
             times a week on 3 separate days

          5. Female patients must be of non-childbearing potential or must agree to use an
             acceptable method of contraception or abstinence, during the study, and 1 month
             following completion of the study

          6. The patient and caregiver are willing and able to participate in all schedule
             evaluations and complete all required tests

        Exclusion Criteria:

          1. Patient was significantly non-compliant in Study ACP-103-032

          2. The Investigator becomes aware of an impending and unexpected change in the patient's
             living situation (e.g., change in caregiver, change in facility, moving from home to
             facility, moving from one family member or caregiver's home to another) that may cause
             a major disruption in the patient's behavior

          3. Patient or study partner/caregiver has a medical condition (e.g., hearing, vision
             impairments) that would impair the ability to perform the study assessments.

          4. Patient is bedridden or has any significant medical condition that is unstable and
             would place the patient at undue risk from study drug or study procedures

          5. Has clinically significant laboratory abnormalities that would jeopardize the safe
             participation of the patient in the study

          6. Has a Global Clinician Assessment of Suicidality (GCAS) score of 3 or 4 based on
             Investigator's assessment of behavior since the last assessment