Data from 2 posters presented at AAIC 2020 suggest that there is an unmet need for safe and effective treatments for patients who experience dementia-related psychosis.
Data from a survey of patients with dementia-related psychosis and their care partners seeking to identify unmet needs in treatment and patient experience suggest that symptoms of visual hallucinations and paranoid delusions carry a high burden for both patients and their caretakers.1,2
The data revealed that a number of patients were either not taking a treatment for their psychosis or their current therapy included adverse events and limited efficacy. All in all, 42% of both patient and care partner respondents reported having no current treatment, with the reported agents being atypical antipsychotics, antidepressants, anxiolytics, and benzodiazepines.
The results were presented virtually at the Alzheimer’s Association International Conference (AAIC) 2020 annual meeting by Teresa Brandt, PhD, MCB, Executive Director of Regulatory Affairs, Acadia Pharmaceuticals. The online survey included 212 patients (n = 26) and care partners (n = 186) who completed the survey on behalf of patients under their care, of which 16 partook in a qualitative interview (patients, n = 1; care partners, n = 15).
“The data shows people with dementia-related psychosis experience hallucinations and delusions that have a substantial burden on their lives,” Brandt said in a statement.3 “We are pleased to be a part of this patient-focused study as it is critical for the treatment triad of patients, caregivers and healthcare providers to better identify and understand these symptoms, and to incorporate the patient’s voice in drug development and evaluation.”
The most common symptoms reported by patients were visual hallucinations (89%), auditory hallucinations (54%), and a distortion of senses (54%). Of those who reported recent visual hallucinations, 61% noted that they occurred weekly. Additionally, the participants described an impact of dementia-related psychosis on their activities of daily living (75%), sleep (63%), family life (56%), and as well as safety concerns (56%).1,2
The care partners, on the other hand, reported that paranoid delusions (76%), visual hallucinations (75%), and lack of trust for loved ones (52%) were the most common symptoms experienced by their patient partners. In total, 77% of the care partners reported paranoid delusions as occurring at least weekly.
“The symptoms of dementia-related psychosis can cause fear and anxiety, disrupting the lives of people living with dementia and their families,” said Virginia Biggar, Senior Director of Communities, UsAgainstAlzheimer’s, in a statement.3
The survey participants noted that in many cases, their current treatment method was less than helpful, with a median visual analog scale (VAS) score of 2 out of 5 (patients: mean score, 2.33 [standard deviation (SD), 1.0]; care partners: mean score, 2.4 [SD, 1.3]). The most common reason for discontinuation of a treatment—reported by 11 patients and 115 partners—was an adverse effect, reported by 27% and 31% of patients and partners, respectively. The next most common reasons were physician recommendation (patients: 27%; care partners: 14%), and lack of symptom improvement (patients: 9%; care partners: 28%).1,2
All told, when queried about what an ideal treatment would provide for them, patients and care partners ranked the ability to distinguish reality (patients: 35%; care partners: 49%) and overall symptom improvement (patients: 42%; care partners: 23%) as the most important benefits.
“The survey results show that many patients with dementia-related psychosis are unaware of what’s happening or how to communicate what they are experiencing. The findings highlight the need for caregivers and healthcare providers to be able to better recognize, report, and manage these symptoms,” Terry Frangiosa, lead investigator, A-LIST Insight Series, UsAgainstAlzheimer’s, said in a statement.3
Additional data presented at AAIC 2020 suggest that a treatment may be on the way, with the results of the phase 3 HARMONY study (NCT03325556) demonstrating that treatment with pimavanserin (Nuplazid; Acadia Pharmaceuticals) produced a robust reduction in psychosis symptoms, irrespective of most likely clinical diagnosis of dementia subtype or baseline dementia severity.4 The agent was recently accepted for review by the FDA for such an indication, the application being supported by the HARMONY data. Its prescription drug user fee act (PDUFA) date was set for April 3, 2021.
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1. Brandt T, Frangiosa T, Biggar V, Taylor A, Keller B, Abler V. Treatment Patterns and Needs for Dementia-related Psychosis Described by Patients and Care Partners (Caregivers): an Observational, Prospective Study to Describe the Patient Experience. Presented virtually at AAIC 2020. Poster 47165.
2. Brandt T, Frangiosa T, Biggar V, Taylor A, Keller B, Abler V. Dementia-related Psychosis Symptoms and Impact from the Patient and Care Partner (Caregiver) Perspective: an Observational, Prospective Study to Describe the Patient Experience. Presented virtually at AAIC 2020. Poster 47164.
3. People with Dementia and Caregivers Share the Significant Burden of Visual Hallucinations and Paranoid Delusions, New Survey Highlights [press release]. Washington, DC; Atlanta, GA; San Diego, CA. UsAgainstAlzheimer’s; Lewy Body Dementia Association; Acadia Pharmaceuticals. Published July 29, 2020. Accessed August 4, 2020. businesswire.com/news/home/20200729005275/en.
4. Foff EP, Devanand DP, Ballard C, McEvoy B, Stankovic S. HARMONY: response to Pimavanserin in the 12-week, open-label treatment phase. Presented virtually at AAIC 2020. Poster 4543.