Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Pimavanserin; Placebo; Quetiapine
Intervention description: Pimavanserin 34 mg (provided as 2×17 mg encapsulated tablets) administered orally as a single dose once daily; Placebo (provided as 2 × placebo encapsulated tablets) administered orally as a single dose once daily; Quetiapine 25 mg (provided as 1×25 mg quetiapine encapsulated tablet and 1 × placebo encapsulated tablet), OR 50 mg (provided as 2×25 mg quetiapine encapsulated tablets), OR 100 mg (provided as 2×50 mg quetiapine encapsulated tablets) administered orally as a single dose once daily
Intervention MeSH terms: Pimavanserin; Quetiapine Fumarate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This is a pilot study to explore the effects of pimavanserin and low-dose quetiapine in
      subjects with Parkinson's disease with neuropsychiatric symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects 50 to 85 years of age, inclusive

          2. Able to understand the protocol requirements and provide written informed consent

          3. Able to complete questions on a handheld device / tablet, is willing to wear an
             actigraph and can be reliably rated on assessment scales

          4. Able to designate an 'informant' (relative, housemate, friend) who can provide
             information about the subject's well being and attend clinic visits with the subject

          5. Is able to swallow the test capsule without difficulty during the Screening visit

          6. Has a Mini-Mental State Examination (MMSE) score ≥19

          7. Has a diagnosis of idiopathic Parkinson's disease, without any other known or
             suspected cause of parkinsonism. Initial diagnosis of PD must have been made more than
             1 year prior to Screening.

          8. Has non-motor neuropsychiatric symptoms severe enough to warrant treatment with an
             antipsychotic agent based on investigator judgement and CGI-S score

          9. If the subject is on anti-Parkinsonian medication, they must be on a stable regimen
             for 1 month prior to Baseline and not planning (at the time of the Baseline visit) to
             make a major change in dose(s)

         10. 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 or be abstinent for at least 1 month prior to the Baseline visit, during
             the study, and 41 days following completion of double-blind treatment.

        Exclusion Criteria:

          1. Has atypical parkinsonism or secondary parkinsonism variants such as tardive or
             medication induced parkinsonism

          2. Is in hospice, is receiving end-of-life palliative care, or is bedridden or confined
             to a wheelchair

          3. Has neuropsychiatric symptoms that are primarily attributable to current delirium or
             substance abuse

          4. Has current evidence of an unstable neurological, cardiovascular, respiratory,
             gastrointestinal, renal, hepatic, hematologic, or other medical or psychiatric
             disorder, including cancer or malignancies that, in the judgment of the Investigator,
             would jeopardize the safe participation of the subject in the study or significantly
             interfere with the conduct or interpretation of the study

          5. Has a known personal or family history of long QT syndrome or family history of sudden
             cardiac death

          6. Has orthostatic hypotension as judged by the investigator and medical monitor

          7. Is judged by the Investigator or the Medical Monitor to be inappropriate for the study
             for any reason, including if the subject is judged to be a danger to self or others

        Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to
        ensure that all criteria for study participation are met. Patients may be excluded from the
        study based on these assessments (and specifically, if it is determined that their baseline
        health and condition do not meet all pre-specified entry criteria).