Detection of Episodic Memory Impairment in MCI Using the Tablet-Based Brief Assessment of Cognition (BAC)

Presented at the International Society for CNS Clinical Trials and Methodology (ISCTM) Annual Scientific Meeting Virtual Edition, April 6-9, 2021

While episodic memory impairment is often the hallmark of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD), impairment may also be observed in executive function, attention, language, and visuospatial skills. The aim of the present work is to assess the utility of the tablet-based BAC to identify and quantify episodic memory and other deficits in MCI due to AD.

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Contribution of cognition and motor symptoms on Virtual Reality Functional Capacity Assessment Tool (VRFCAT-SL) performance in Parkinson’s disease

Presented at the American Academy of Neurology Virtual Annual Meeting, April 17-22, 2021

The VRFCAT-SL was administered to a sample of 29 patients with Parkinson’s disease during clinical neuropsychological evaluation. Based on the analysis presented in this poster, the VRFCAT-SL appears to provide a useful measure of cognitive functional capacity that is not confounded by Parkinson’s disease motor symptoms. Completion time of the VRFCAT-SL is associated with visual memory, sustained attention, and set-switching.

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Real-time capture of gait and actigraphy using industry-grade wearable devices in older adults with and without subjective cognitive decline: Preliminary findings regarding feasibility, sensitivity and correlations with cognition

Presented at the Clinical Trials on Alzheimer’s Disease (CTAD) Digital Event, November 4-7, 2020

Integration of wearable devices into regulated clinical trials for the assessment of cognition and function continues to be a topic of growing interest. If appropriately implemented, measurements from validated wearable technologies have the potential to revolutionize the conduct of clinical trials by facilitating development of site-less clinical trial designs. In order to be truly informative, however, endpoints collected by these devices must undergo the same clinical and technological validation process currently required by other currently accepted tools. This poster reports preliminary findings from an on-going NIH-funded study examining the relationship between real-time measurements of gait and actigraphy collected by industry grade wearable devices and established cognitive and functional endpoints with sensitivity to decline early in the AD continuum.

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The Placebo-Control Reminder Script in Depression and Psychosis Trials: An Antidote for the Placebo and Nocebo Response

Presented at the ASCP Annual Meeting May 29-31,2020 Virtual Conference

Depression and psychosis clinical trials share a crucial commonality of perpetually and alarmingly high placebo and nocebo responses. At ASCP in May 2019, Cohen, et al. presented data indicating that the Placebo-Control Reminder Script (PCRS) significantly reduced the placebo effect among subjects in a major depressive episode (MDE). Since then, the same study design, was applied among subjects with a psychotic disorder. This poster presents these data and the combined results from both populations.

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Wearable Insoles for the Real-Time Capture of Gait Measures: Preliminary Feasibility and Validity Data in Older Adults With and Without Subjective Cognitive Decline

Presented at the ASCP Annual Meeting May 29-31,2020 Virtual Conference

Integration of wearable devices into regulated clinical trials for the assessment of cognition and functioning continues to be a topic of growing interest. If appropriately implemented, measurements from validated wearable technologies have the potential to revolutionize the conduct of clinical trials by facilitating the development of site-less clinical trial designs. In order to be truly informative, however, endpoints collected by these devices must undergo the same clinical and technological validation process required by other currently accepted tools. This poster presents preliminary data from an ongoing study examining the reliability of industry-grade pressure sensing insoles for the real-time capture of gait measures in older adults, and the relationship between gait measures and standard measures of cognition and functioning.

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Translation and cultural adaptation of the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) to measure performance-based functioning in global clinical trials in German, Italian, Russian, Polish, and Spanish for US

Presented at the ASCP Annual Meeting May 29-31,2020 Virtual Conference

The VRFCAT is currently used in industry trials across diverse CNS indications including major depression and Parkinson’s disease. In order to meet a growing need for culturally appropriate performance-based assessments of functioning in global clinical trials, we recently completed translation and cultural adaptation of the VRFCAT for use in Italian, Polish, Russian, German, and Spanish for the US.This poster describes the methods used for professional translation and cultural adaptation of the VRFCAT, and results from the cognitive debriefing and pilot testing conducted at in-country investigational sites.

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