Validation of a Performance Based Measure of Functioning in MCI and Early AD

Project SummaryAlzheimer s diseaseADis expected to rise in prevalence fromtomillion Americans byleading toof deaths among adults overThis epidemic is projected to overwhelm healthcare and economic resourceswith costs reaching $billion in the US inand $trillion byThere is no cure for ADand no new drugs have been successful in treating the advanced stages of AD related dementiaA growing body of research suggests that early phases of the diseasesuch as Mild Cognitive ImpairmentMCIand mild ADare more likely to be responsive to disease modifying compoundsDrug development strategies are focused primarily on prevention and early intervention in these high riskearly AD populationsAdvances in clinical trials will require psychometrically rigorous measures capable of detecting subtle cognitive and functional changes indicative of the early disease processAccurate assessment of functional capacity is especially critical for determining whether investigational treatments provide meaningful therapeutic benefit to everyday functioningMany tests of functional ability are designed to assess basic activities of daily livingADLssuch as bathing and eatingHoweverthese skills are typically preserved in MCI and mild ADIn these early phasessubtle but observable deficits are more likely to occur in instrumental ADLsIADLssuch as shopping and cookingAt presentthere are limited options for reliablesensitive determination of IADL functioning in these critical populationsThe shortcomings of traditional functional assessments used in AD drug trials have been well established and include biases in caregiver reportslack of established reliabilityand outdated role play tasksDespite growing scientific consensus regarding the need for improved measurement of functional capacityno new assessments have been developed for use in MCI or mild ADNeuroCog Trials developed the Virtual Reality Functional Capacity Assessment ToolVRFCATas a computerized performance based assessment of functional capacity designed to simulate real world IADLsUsing a realistic virtual environmentthe VRFCAT assesses functional performance in the context of a typical trip to the grocery storeInitially developed for use in patients with severe mental illnessthe VRFCAT has demonstrated strong psychometric properties and has been implemented in large scale clinical trials for schizophrenia and major depressionThe proposed Fast Track project will create and validate a new version of the VRFCAT specifically for MCI and mild ADVRFCAT MCIbased on established standards for adapting computerized cognitive tests for new target groupsPilot testing will assess the suitability of the existing VRFCAT and identify any needed software customizationsIn Phase IIwe will execute a comprehensive validation study to examine the psychometric properties of the VRFCAT MCIbroadening the commercial and scientific value of this innovative tool in an effort to accelerate breakthrough treatments to delayslowand prevent AD Project Narrative Traditional functional assessments used in Alzheimer s diseaseADdrug trials lack sensitivity to subtle deficits observed early in the diseaseat the stages of mild cognitive impairmentMCIand mild ADThis poses a problem when assessing the effectiveness of novel therapeutic treatments for early stage diseaseand highlights the need for improved measures for use in clinical trialsThe current project will develop and validate the Virtual Reality Functional Capacity Assessment Tool for MCI and Mild ADVRFCAT MCIa novel performance based assessment of function with improved sensitivity to functional impairments in MCI and early stage AD