Efficacy results of pimavanserin from a multi-center, open-label extension study in Parkinson's disease psychosis patients

© 2021 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license.Introduction: Pimavanserin, a selective 5-HT2A inverse agonist/antagonist, was approved for hallucinations and delusions associated with Parkinson's disease psychosis (PDP). We present durability of response with pimavanserin in patients with PDP for an additional 4 weeks of treatment. Methods: This was an open-label extension (OLE) study in patients previously completing one of three double-blind, placebo-controlled (Core) studies. All patients received pimavanserin 34 mg once daily. Efficacy assessments included the Scale for the Assessment of Positive Symptoms (SAPS) PD and H + D scales, Clinical Global Impression (CGI) Improvement and Severity scales and Caregiver Burden Scale (CBS), through 4 weeks in the OLE. Safety assessments were conducted at each visit. Results: Of 459 patients, 424 (92.4%) had a Week 4 efficacy assessment. At Week 4 (10 weeks total treatment), SAPS-PD mean (standard deviation) change from OLE baseline was -1.8 (5.5) and for SAPS-H + D was -2.1 (6.2) with pimavanserin 34 mg. Patients receiving placebo during the Core studies had greater improvements (SAPS-PD -2.9 [5.6]; SAPS-H + D -3.5 [6.3]) during the OLE. For participants treated with pimavanserin 8.5 or 17 mg during the Core studies, further improvement was observed during the OLE with pimavanserin 34 mg. The mean change from Core Study baseline for SAPS-PD score was similar among prior pimavanserin 34 mg and prior placebo-treated participants (-7.1 vs. -7.0). The CGI-I response rate (score of 1 or 2) at Week 4 was 51.4%. Adverse events were reported by 215 (46.8%) patients during the first 4 weeks of OLE. The most common AEs were fall (5.9%), hallucination (3.7%), urinary tract infection (2.8%), insomnia (2.4%), and peripheral edema (2.2%) CONCLUSIONS: Patients previously on pimavanserin 34 mg during three blinded core studies had durability of efficacy during the subsequent 4 week OLE SAPS-PD assessment. Patients previously on blinded placebo improved after 4 weeks of OL pimavanserin treatment. These results in over 400 patients from 14 countries support the efficacy of pimavanserin for treating PDP.info:eu-repo/semantics/publishedVersio

El ADNe. La tecnología algorítmica que cambia el modelo educativo para siempre

[ES] El objetivo de este artículo es mostrar una nueva herramienta capaz de garantizar una formación personalizada, predictiva, preventiva y precisa basada en el análisis del persotipo del ADN emocional (ADNe), lo que nos permite identificar la adecuación que posee y el método de corrección requerido en cada individuo para asimilar conocimientos teóricos y prácticos. Su utilidad en el es enorme al permitir una completa gestión del talento individual y colectivo con respecto a los logros académicos y profesionales a alcanzarAzulay, E.; Del Real, H.; Morant-Martínez, O.; Marín-Roig Ramón, J.; Santandreu Mascarell, C. (2018). El ADNe. La tecnología algorítmica que cambia el modelo educativo para siempre. Journal of Management and Business Education (JMBE). 1(2):41-63. http://hdl.handle.net/10251/121786S41631

The AIQ Meta-Testbed: Pragmatically Bridging Academic AI Testing and Industrial Q Needs

AI solutions seem to appear in any and all application domains. As AI becomes more pervasive, the importance of quality assurance increases. Unfortunately, there is no consensus on what artificial intelligence means and interpretations range from simple statistical analysis to sentient humanoid robots. On top of that, quality is a notoriously hard concept to pinpoint. What does this mean for AI quality? In this paper, we share our working definition and a pragmatic approach to address the corresponding quality assurance with a focus on testing. Finally, we present our ongoing work on establishing the AIQ Meta-Testbed.Comment: Accepted for publication in the Proc. of the Software Quality Days 2021, Vienna, Austri

A digitally-augmented ground space with timed visual cues for facilitating forearm crutches’ mobility

Persuasive technologies for physical rehabilitation have been pro posed in a number of different health interventions such as post-stroke gait rehabilitation. We propose a new persuasive system, called Augmented Crut ches, aimed at helping people to walk with crutches. People with injuries, or with any sort of mobility problem typically use assistive devices such as crut ches, walkers or canes in order to be able to walk more independently. However, walking with crutches is a learning skill that needs continuous repetition and constant attention to detail in order to walk correctly with them and without suffering negative consequences, such as falls or injuries. In close collaboration with therapists, we identify the main issues that patients face when walking with crutches. These vary from person to person, but the most common and hardest challenges are the position and coordination of the crutches. Augmented Crut ches studies human behavior aspects in these situations and augments the ground space around the user with digital visual cues where timing is the most important factor, without the need for a constant therapist providing manual help. This is performed through a mini-projector connected to a smartphone, worn by the user in a portable, lightweight manner. Our system helps people to learn how to walk using crutches with increased self-confidence and motivation. Additionally, our work identifies timing, controllability and awareness as the key design dimensions for the successful creation of persuasive, interactive experiences for learning how to walk with crutches.info:eu-repo/semantics/publishedVersio

Perceived Object Stability Depends on Multisensory Estimates of Gravity

BACKGROUND: How does the brain estimate object stability? Objects fall over when the gravity-projected centre-of-mass lies outside the point or area of support. To estimate an object's stability visually, the brain must integrate information across the shape and compare its orientation to gravity. When observers lie on their sides, gravity is perceived as tilted toward body orientation, consistent with a representation of gravity derived from multisensory information. We exploited this to test whether vestibular and kinesthetic information affect this visual task or whether the brain estimates object stability solely from visual information. METHODOLOGY/PRINCIPAL FINDINGS: In three body orientations, participants viewed images of objects close to a table edge. We measured the critical angle at which each object appeared equally likely to fall over or right itself. Perceived gravity was measured using the subjective visual vertical. The results show that the perceived critical angle was significantly biased in the same direction as the subjective visual vertical (i.e., towards the multisensory estimate of gravity). CONCLUSIONS/SIGNIFICANCE: Our results rule out a general explanation that the brain depends solely on visual heuristics and assumptions about object stability. Instead, they suggest that multisensory estimates of gravity govern the perceived stability of objects, resulting in objects appearing more stable than they are when the head is tilted in the same direction in which they fall

Elevated visual dependency in young adults after chemotherapy in childhood

Chemotherapy in childhood can result in long-term neurophysiological side-effects, which could extend to visual processing, specifically the degree to which a person relies on vision to determine vertical and horizontal (visual dependency). We investigated whether adults treated with chemotherapy in childhood experience elevated visual dependency compared to controls and whether any difference is associated with the age at which subjects were treated. Visual dependency was measured in 23 subjects (mean age 25.3 years) treated in childhood with chemotherapy (CTS) for malignant, solid, non-CNS tumors. We also stratified CTS into two groups: those treated before 12 years of age and those treated from 12 years of age and older. Results were compared to 25 healthy, age-matched controls. The subjective visual horizontal (SVH) and vertical (SVV) orientations was recorded by having subjects position an illuminated rod to their perceived horizontal and vertical with and without a surrounding frame tilted clockwise and counter-clockwise 20° from vertical. There was no significant difference in rod accuracy between any CTS groups and controls without a frame. However, when assessing visual dependency using a frame, CTS in general (p = 0.006) and especially CTS treated before 12 years of age (p = 0.001) tilted the rod significantly further in the direction of the frame compared to controls. Our findings suggest that chemotherapy treatment before 12 years of age is associated with elevated visual dependency compared to controls, implying a visual bias during spatial activities. Clinicians should be aware of symptoms such as visual vertigo in adults treated with chemotherapy in childhood