Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease (SERENE)
Condition: Agitation and Aggression in Alzheimer's Disease
MeSH terms: Alzheimer Disease; Psychomotor Agitation; Aggression
Intervention: Pimavanserin 34 mg; Pimavanserin 20 mg; Placebo
Intervention description: Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth; Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth; Placebo, taken as two tablets, once daily by mouth
Intervention MeSH terms: Pimavanserin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 111.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of pimavanserin compared with placebo in treatment of agitation and
      aggression after 12 weeks of treatment
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, 50 years of age or older

          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. Has a diagnosis of probable AD according to the National Institute on
             Aging-Alzheimer's Association (NIA-AA) guidelines

          4. Meets criteria for agitation according to the International Psychogeriatric
             Association (IPA) guidelines

          5. Lives at home or in an assisted living or care facility (but has the capacity to visit
             the clinic as an outpatient). Subjects must have been at their current location for at
             least 3 weeks prior to Screening and plan to remain at the same location for the
             duration of the trial.

          6. Has a designated study partner/caregiver who is in contact with the patient at least 3
             times a week on 3 separate days

          7. Female patients must be of non-childbearing potential or must agree to use an
             acceptable method of contraception or abstinence , for at least 1 month prior to
             randomization, during the study, and 1 month following completion of the study

          8. The patient and caregiver are willing and able to participate in all schedule
             evaluations and complete all required tests

        Exclusion Criteria:

          1. The agitation/aggression is attributable to concomitant medications, environmental
             conditions, substance abuse, or active medical or psychiatric condition

          2. Patient is receiving skilled nursing care for any medical condition other than
             dementia

          3. Treatment with an antipsychotic medication within 2 weeks of Baseline visit or 5 half
             lives, whichever is longer

          4. Patient or study partner/caregiver has a medical condition (e.g., hearing, vision
             impairments) that would impair the ability to perform the study assessments.

          5. Has had a myocardial infarction within the last six months

          6. Has a history or symptoms of long QT syndrome

          7. Has a history of a significant psychotic disorder before or during the diagnosis of
             probable Alzheimer's disease (including, but not limited to schizophrenia or bipolar
             disorder)

          8. 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 9. Has a
             sensitivity to pimavanserin or its excipients

        10. Has previously participated in a clinical study with pimavanserin

        11. Has a Global Clinician Assessment of Suicidality (GCAS) score of 3 or 4 based on
        Investigator's assessment of behavior within the last 3 months at Screening or since last
        visit at Baseline