Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis
Condition: Dementia-related Psychosis
MeSH terms: Dementia; Psychotic Disorders; Mental Disorders
Intervention: Placebo; Pimavanserin 34 mg; Pimavanserin 20 mg
Intervention description: Placebo, tablets, once daily by mouth; Pimavanserin 34 mg total daily dose, tablets, once daily by mouth; Pimavanserin 20 mg total daily dose, tablets, once daily by mouth
Intervention MeSH terms: Pimavanserin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 392.0
Sex: All
Minimum age: 50 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Dementia; Dementia-related psychosis; Dementia associated with Parkinson's disease; Dementia with Lewy bodies; Alzheimer's disease; Behavioral variant frontotemporal dementia; Progressive supranuclear palsy; Corticobasal degeneration; Vascular dementia; Hallucinations; Delusions; Psychosis

Summary:

      The purpose of this study is to evaluate the efficacy of pimavanserin compared to placebo in
      preventing relapse of psychotic symptoms in subjects with dementia-related psychosis who
      responded to 12 weeks of open label pimavanserin treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Meets criteria for All-cause Dementia according to NIA-AA guidelines

          2. Meets clinical criteria for one of the following disorders: Dementia associated with
             Parkinson's disease, Dementia with Lewy bodies, Possible or probable Alzheimer's
             disease, Frontotemporal degeneration spectrum disorders, Vascular dementia

          3. Has an MMSE score ≥6 and ≤24

          4. Has had psychotic symptoms for at least 2 months

          5. Must be on a stable does of cholinesterase inhibitor or memantine, if applicable

          6. If the subject is female, she must not be pregnant or breastfeeding. She must also be
             of non-childbearing potential or must agree to use a clinically acceptable method of
             contraception for the duration of the study

        Exclusion Criteria:

          1. Has psychotic symptoms that are primarily attributable to a condition other than
             dementia

          2. Has had a recent major depressive episode

          3. Has experienced suicidal ideation or behavior within 3 months prior to study
             enrollment

          4. Has evidence of a non-neurologic medical comorbidity or medication use that could
             substantially impair cognition

          5. Has a history of ischemic stroke within the last 12 months or any evidence of
             hemorrhagic stroke

          6. Has a known history of cerebral amyloid angiopathy (CAA), epilepsy, CNS neoplasm, or
             unexplained syncope

          7. Has any of the following: greater than New York Heart Association (NYHA) Class 2
             congestive heart failure, Grade 2 or greater angina pectoris, sustained ventricular
             tachycardia, ventricular fibrillation, torsade de pointes, syncope due to an
             arrhythmia, an implantable cardiac defibrillator

          8. Had a myocardial infarction within the last 6 months

          9. Has a known personal or family history or symptoms of long QT syndrome

         10. Has a significant unstable medical condition that could interfere with subject's
             ability to complete the study or comply with study procedures

         11. Requires treatment with a medication or other substance that is prohibited by the
             protocol

        Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to
        ensure that all criteria for study participation are met.