Objective: The INSYTE Study–seeks to gain a better understanding of the management of PDP. INSYTE will describe the relative safety and effectiveness of various antipsychotic (AP) therapies and other treatment regimens, as well as comparative clinical, economic, and humanistic outcomes for both patients and caregivers within the context of real-world medical practice.

Background: Despite the prevalence of PDP, little is known regarding the treatment of PDP in real-world medical practice settings. Although the association between advanced PD and the development of psychotic symptoms has been known for several years, relatively little information is available regarding the role that AP therapy may play in treating the condition, and in mitigating the burden of PDP on the healthcare system by reducing falls, hospitalizations and placement of PDP patients in long-term care facilities.

Methods: INSYTE is an ongoing study expected to enroll 750 patients and their caregivers from approximately 100 sites; patients are followed for 36 months. INSYTE employs validated assessment instruments, although as an observational study, does not impose a pre-defined visit schedule, medical tests, laboratory tests, procedures, or interventions.

Results: Baseline data for 90 patients enrolled to date found that a majority are male (63.3%), white (95.6%), and live in a private residence (93.3%) with or without a caregiver. The average patient age is 75.5 years. At baseline, 20% of patients had mild/mild to moderate PD, 58% had moderate/moderate to advanced PD, and 20% had advanced PD. Using the Clinical Global Impression Severity Scale, 39% of patients were borderline to mildly mentally ill and 46% were moderately to markedly ill. Time since PD diagnosis ranged from 1 to 22 years (mean = 8.86 years); most patients, 63.3%, were diagnosed with PDP a year or less prior to study enrollment (mean years since PDP diagnosis = 1.58 years). AP use was reported in 40% of patients; 29% used pimavanserin alone or in combination with other APs.

Conclusions: INSYTE is the first large observational study to evaluate how patients with PDP are treated in the real-world setting, and how these treatments impact patients. AP use among patients diagnosed with PDP is low. Results from this study will inform on the real-world care of PDP patients, potentially informing PDP treatment guidelines and standards of care.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/examining-parkinsons-disease-psychosis-treatment-outcomes-in-the-real-world-the-insyte-observational-study/