Measurement of Neuropsychiatric Symptoms in Clinical Trials Targeting Alzheimer's Disease and Related Disorders

Abstract

Behavioral and psychological symptoms (BPSD) are now known to be frequently associated to cognitive and functional decline in Alzheimer‘s disease and related disorders. They are present since the early stages of the disease and have negative impact on the disease process. BPSD assessment is crucial in clinical practice and also in future clinical trials targeting disease-modifying therapies for dementia. In this article, we will first review current assessment tools for BPSD, mainly global and domain-specific scales, and new assessment methods, currently available or in development, including new scales, diagnostic criteria and new technologies such as ambulatory actigraphy.

The Hyperactivity–Impulsivity–Irritiability–Disinhibition–Aggression–Agitation Domain in Alzheimer’s Disease: Current Management and Future Directions

“…Moreover, future pharmacological studies that perform detailed symptom characterization and treatment evaluation via the DICE approach are more likely to reveal which patients will benefit most from certain pharmacotherapies. To further improve symptom characterization and treatment implementation in the real world, studies should also focus on bettering environmental and wearable sensors to make them more accessible to patients in clinical settings (Bharucha et al, 2009; David et al, 2010).…”

“…To address concerns regarding inadequate resources in clinical settings for characterizing symptoms, implementing non-pharmacological interventions, and evaluating treatment responses, the literature suggests the use of environmental and wearable sensors (Bharucha et al, 2009; David et al, 2010; Kikhia et al, 2015). By continuously measuring patients’ behavior, these sensors are capable of detecting changes from routine and of collecting much more data than is possible with a limited nursing home staff or a single caregiver (Kikhia et al, 2015).…”

“…Moreover, this intervention was so well tolerated by patients and their caregivers that all who received it opted to continue using it following the completion of the study. Other research has demonstrated that actigraphy—the use of a small, unobtrusive accelerometer to measure motor activity—is a feasible and inconspicuous method that can indirectly and objectively measure the timing and frequency of various BPSD, including agitation and aberrant motor activity (Volkers et al, 2003; Mahlberg et al, 2007; David et al, 2010; Mulin et al, 2011). Overall, ambient and wearable sensors represent a promising way to improve the implementation of both pharmacological and non-pharmacological interventions for BPSD.…”

A review of current information and communication technologies: can they be used to assess apathy?

“…The ICT have been proposed in several studies as a new approach for the evaluation of NPS, because they can provide a more objective assessment in clinical trials than currently used tools (David et al ., , Robert et al ., ). In particular ICT assessments involving measurement of physical behavior by movement sensors and imaging and video processing, are of interest because they allow capturing the patients' performances and actions in real time and real life situations as well as changes induced by apathy at a level that is not yet detectable by a human observer.…”

Neuropsychiatric Symptoms in Mild Cognitive Impairment as Risk Factors for Progression to Dementia

“…We can use different general scales and focused scales to determine the presence, intensity or frequency of NPS in patients with MCI and dementia. General scales are used in multidimensional examinations [10], and include the Behavioral Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD), the Neurobehavioral Rating Scale, the Behavioral Rating Scale for Dementia, and the Neuropsychiatric Inventory (NPI). The NPI is the most widely used scale to measure NPS associated with cognitive disorders [11].…”