Nuplazid Parkinson’s medication also found to improve quality of life
Drug approved in US for treating disease-related psychosis in patients
Four months of daily Nuplazid (pimavanserin), an approved oral therapy for psychosis associated with Parkinson’s disease, was also found to significantly improve cognitive abilities, daily living activities, and health-related quality of life for patients in a Phase 4 study.
“These findings suggest that treatment with [Nuplazid] can result in both an improvement in psychosis and corresponding improvements in various health outcomes and health-related quality of life metrics,” the researchers wrote.
The study focused on Nuplazid’s impact on several measures of physical and psychological functions, as assessed by clinicians, patients, and caregivers. The results showed gains across all areas, but specifically in activities of daily living, or “typical ADLs required for day-to-day activities such as eating, dressing, and bathing,” according to the team.
“These findings demonstrate a parallel improvement in psychosis symptom scores with an improvement in functional outcome scores,” the researchers wrote.
Titled “The effects of treatment with pimavanserin on activities of daily living in patients with Parkinson’s disease psychosis: a 16-week, single-arm, open-label study,” the work was published in the journal Therapeutic Advances in Neurological Disorders.
Over half of Parkinson’s patients experience hallucinations or delusions
As many as 60% of people with Parkinson’s experience psychosis, marked by hearing or seeing things that aren’t real (hallucinations) or false beliefs that conflict with reality (delusions). Such symptoms can impair patients’ cognitive abilities, the management of daily activities, and quality of life.
Nuplazid, by Acadia Pharmaceuticals, is a medication approved in the U.S. to treat hallucinations and delusions associated with Parkinson’s disease psychosis, or PDP. In clinical trials, the treatment outperformed a placebo in reducing the frequency and intensity of hallucinations and delusions.
However, few studies have investigated Nuplazid’s effect on cognition, health-related quality of life, dubbed HRQoL, and activities of daily living, or ADLs.
This Acadia-sponsored Phase 4 clinical trial (NCT04292223), a type of study conducted after marketing approval, was “the first to utilize several validated assessment tools to evaluate the effects of [Nuplazid] on ADLs and function and psychosis symptoms in patients with PDP,” the researchers wrote.
Of 70 Parkinson’s patients screened, a total of 29 entered the study, all with severe psychosis. Among them, the mean age was 70.2, 62% were male, 97% were living at home, and 52% had a spouse or partner as their caregiver.
All of the patients received once-daily Nuplazid for 16 weeks, or about four months. Before treatment, known as baseline, and throughout the study period, participants underwent a battery of tests related to ADLs and function. Some tests included both the patient and caregiver.
Nuplazid Parkinson’s medication led to gains in activities of daily living
The study’s main goal was a change in the functional status questionnaire (FSQ), a self-administered assessment that measures the impact of psychosis on physical, psychological, social, and role functions.
After 16 weeks, the participants showed significant improvements in FSQ scores from baseline, with changes significantly observed as early as week 12. Improvements were seen in various FSQ subscales, including physical function, psychological function, social activity, and quality of interaction. Some improvements were seen as early as week four, or within one month.
Clinicians’ assessments of disease severity were measured by the clinical global impression of severity (CGI-S), while overall health status was assessed using the clinical global impression of improvement (CGI-I). Both showed significantly better scores at week 16, with improvements starting as early as week 2.
Our findings in this 16-week open-label study indicate that [Nuplazid] treatment for the improvement of hallucinations and delusions in patients with [Parkinson’s disease psychosis] is associated with an improvement in ADLs and function.
The patients self-reported significant enhancements in cognition, behavior, and mood, as indicated by MDS-UPDRS part 1 scores. They also reported improvements in ADLs, including speech, swallowing, handwriting, and dressing, as assessed by MDS-UPDRS part 2. Scores using the self-reported global impression of improvement (PGI-I) also significantly improved by week 16.
While there was a numeric improvement using the Schwab and England ADL scale, to ensure the inclusion of patients with sufficient disability, it did not reach statistical significance. This scale is a tool to assess a person’s ability to independently perform basic activities necessary for daily living.
The caregiver strain index (CSI) scores showed that caregivers reported significantly less stress by week 16, with improvement beginning in week four. Significant improvements were seen in both sleep severity and sleep distress, as measured by the neuropsychiatric inventory–questionnaire. Self-report depression, via the geriatric depression scale, also significantly improved by week 16.
Treatment-emergent adverse events (TEAEs) were consistent with Nuplazid’s known safety profile, and no new safety signals were observed. One heartbeat-related TEAE led to study discontinuation.
“Our findings in this 16-week open-label study indicate that [Nuplazid] treatment for the improvement of hallucinations and delusions in patients with PDP is associated with an improvement in ADLs and function,” the researchers concluded.
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