A Study of the Safety and Efficacy of Pimavanserin in Patients With Alzheimer's Disease Psychosis
Condition: Alzheimer's Disease Psychosis
MeSH terms: Alzheimer Disease; Psychotic Disorders; Mental Disorders
Intervention: Pimavanserin tartrate; Placebo
Intervention description: Pimavanserin tartrate, 40 mg (two 20 mg tablets), once daily by mouth (equivalent to 34 mg free base pimavanserin); Placebo, 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: 181.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of pimavanserin 40 mg compared to placebo in
      patients with Alzheimer's disease psychosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must be 50 years of age or older with NINCDS-ADRDA defined possible or
             probable AD

          -  Patient must have psychotic symptoms that developed after the diagnosis of AD was
             established. These symptoms must include visual and/or auditory hallucinations, and/or
             delusions

          -  Patient must have been a nursing home resident for ≥ 4 weeks prior to randomization,
             not bedridden and expected to remain in the facility throughout the study

          -  Patient must have actively experienced and verbally communicated psychotic symptoms
             during the month prior to the Screening visit and weekly during the previous 2 weeks
             prior to Baseline

          -  If patient is on acetylcholinesterase inhibitor (AChEI) therapy and/or memantine, must
             be on stable doses for 3 months prior to the Baseline visit and during the study

          -  Patient is willing and able to provide informed consent. If the subject is unable to
             provide written consent due to the severity of dementia, consent must be given by a
             legally authorized representative

        Exclusion Criteria:

          -  Patient has a history of significant psychotic disorders prior to or concomitantly
             with the diagnosis of Alzheimer's disease including, but not limited to, schizophrenia
             or bipolar disorder

          -  Patient is unable to communicate verbally

          -  Patient has current evidence of a serious and/or unstable cardiovascular, respiratory,
             gastrointestinal, renal, hematologic or other medical disorder, including cancer or
             malignancies, which would affect the patient's ability to participate in the study

          -  Patient has had a myocardial infarction in the last six months

          -  Patient has moderate to severe congestive heart failure

          -  Patient has any surgery planned during the screening, treatment, or follow-up periods
             that could interfere with participation in the study per the protocol assessments

        Patients will be evaluated at screening to ensure that all criteria for study participation
        are met. These evaluations will include specific measures of psychosis severity, delirium,
        dementia, cardiovascular condition, and pregnancy status. Patients may be excluded from the
        study based on these assessments (and specifically if it is determined that their baseline
        health and psychiatric condition do not meet all protocol-specified entry criteria).