Presented at AACAP Annual Meeting, Seattle, WA, USA, October 22-27, 2018

A MULTICENTER, RANDOMIZED, ACTIVE-CONTROL REGISTRATION TRIAL(STARS-ADHD) TO ASSESS THE EFFICACY AND SAFETY OF A NOVEL, HOME-BASED, DIGITAL TREATMENT FOR PEDIATRIC ATTENTION-DEFICIT HYPERACTIVITY DISORDER

S.H. Kollins,1 J. Bower,2 R.L. Findling,3 R. Keefe,1,4 J.N. Epstein,5 A.J. Cutler,6 R. White,7 L. Aberle,7 D. DeLoss,2 S.V. Faraone8 31249 1Psychiatry and Behavioral Sciences, Duke University, Durham, NC, USA; 2Akili Interactive, Boston, MA, USA; 3Child and Adolescent Psychiatry, Johns Hopkins University/Kennedy Krieger Institute, Baltimore, MD, USA;4NeuroCog Trials, Inc., Durham, NC, USA; 5Behavioral Medicine and Clinical Psychology, Cincinnati Children’s Hospital, Cincinnati, OH, USA; 6Psychiatry, Meridien Research, Tampa, FL, USA; 7Duke Clinical Research Institute, Durham, NC, USA; 8Psychiatry and Neuroscience & Physiology, SUNY Upstate Medical University, New York, NY, USA

Introduction

• There are well-established pharmacologic and non-pharmacologic treatments for attention-deficit hyperactivity disorder (ADHD),1-4 but limitations to these treatments likely contribute to poor adherence over time. There is an ongoing need for novel approaches to ADHD treatment.
• AKL-T01 is an investigational therapeutic digital intervention in development for the treatment of attention and inhibitory control deficits in pediatric ADHD. – A proof-of-concept study of AKL-T01 demonstrated feasibility of use, improved attention, response inhibition, and working memory in pediatric patients with ADHD.5
• We present primary efficacy and safety results of the randomized Software Treatment for Actively Reducing Severity of ADHD (STARS-ADHD) trial of AKL-T01 versus an active control in pediatric patients with ADHD.

 

Presented at the CHADD 2018 Annual International Conference on ADHD, November 8-11, 2018 in St. Louis, Missouri

A MULTICENTER, RANDOMIZED, ACTIVE-CONTROL REGISTRATION TRIAL (STARS-ADHD) TO ASSESS THE EFFICACY AND SAFETY OF A NOVEL, HOME-BASED, DIGITAL TREATMENT FOR PEDIATRIC ADHD
S.H. Kollins,1 J. Bower,2 T. Ala’ilima,2 R.L. Findling,3 R Keefe,1,4 J.N. Epstein,5 A.J. Cutler,6 R. White,7 L. Aberle,7 D. DeLoss,2 E. Cañadas,2 S.V. Faraone8 1Psychiatry and Behavioral Sciences, Duke University, Durham, NC, USA; 2Akili Interactive, Boston, MA, USA; 3Child and Adolescent Psychiatry, Johns Hopkins University/Kennedy Krieger Institute, Baltimore, MD, USA; 4VeraSci, Inc., Durham, NC, USA; 5Behavioral Medicine and Clinical Psychology, Cincinnati Children’s Hospital, Cincinnati, OH, USA; 6Psychiatry, Meridien Research, Tampa, FL, USA; 7Duke Clinical Research Institute, Durham, NC, USA; 8Psychiatry and Neuroscience & Physiology, SUNY Upstate Medical University, New York, NY, USA

Introduction:

• There are well-established pharmacologic and non-pharmacologic treatments for attention-deficit hyperactivity disorder (ADHD),1-4 but limitations to these treatments likely contribute to poor adherence over time. There is an ongoing need for novel approaches to ADHD treatment.
• AKL-T01 is an investigational therapeutic digital intervention in development for the treatment of attention and inhibitory control deficits in pediatric ADHD.
• We present primary efficacy and safety results of the randomized Software Treatment for Actively Reducing Severity of ADHD (STARS-ADHD) trial of AKL-T01 versus an active control in pediatric patients with ADHD.

 

Presented at CTAD and CNS Summit 2018

VeraSci presented results of a recent study utilizing is a brief tablet-based assessment of the paper-and-pencil based Brief Assessment of Cognition (BACS) assessing multiple cognitive domains, including verbal memory, working memory, motor function, verbal fluency, processing speed and executive function. We presented results examining criterion validity for the assessment of cognition in individuals with subjective cognitive decline by assessing the diagnostic sensitivity, specificity and test-retest reliability of the BAC App endpoints.

Psychometric analysis showed intra-class correlations (ICC) for the BAC App composite were strong, ICC>.80 for Young Adults, Older Adults, and individuals with Subjective Cognitive Decline (SCD). Each test had one measure that produced an ICC of 0.74 or greater for the SCD group. The lowest ICC was observed for the Tower of London for the Young Adult and Older Adult groups and the Token Motor for the Subjective Cognitive Decline group. When a cut-off point of 1.5 SD was used, individuals without SCD were accurately identified 86.89% of the time (specificity), with a 90% chance that this identification is accurate (NPV).Findings suggest that the BAC App has good test-retest reliability; individual subtests demonstrate higher test-retest for individuals classified with SCD. The BAC App has good discriminative validity in terms of specificity and predictive value for categorizing SCD.

 

Presented at CTAD 2018

Poster 74 “Assessing decline in visuospatial working memory associated with subjective cognitive impairment using a tablet-based measure of hippocampal-dependent learning”

Authors: Alexandra S. Atkins, Anzalee Khan, Daniel Ulshen, John Harrison, Brenda L. Plassman,Kathleen A. Welsh-Bohmer & Richard S.E. Keefe

VeraSci presented results of a recent study utilizing a novel tablet-based visuospatial working memory (VSWM) task to examine differences between healthy older adults with and without subjective cognitive decline (SCD). Our VSWM task, developed in collaboration with AD opinion leader John Harrison, assesses the ability to encode and maintain the identity and location of increasingly complex sequences of visual stimuli.

Statistically significant differences in VSWM performance were demonstrated between young adults (YAs), older adults (OAs) and older adults with SCD. Bonferroni post hoc tests showed a significant difference between the YA group, the OA group and the SCD group, with the OA group performing significantly worse than the YA group and the SCD group performing significantly worse than the OA group on three measures (p≤0.001 for all comparisons). Findings suggest that this brief assessment of visuospatial working memory may be sensitive to the earliest stages of cognitive impairment. The specificity of observed declines in hippocampal-dependent tasks such as this offer a link to underlying AD pathology not provided by more global cognitive screening instruments

 

Anzalee Khan, PhD, Senior Director of Data Science at VeraSci, presented “Evaluation of Relationship Between Negative Symptoms Scales in an IRT Framework.” at ISCTM’s 2018 autumn conference. There are many assessments of negative symptoms in schizophrenia with no clear consensus on the primary scale to use for this population as the constructs and general utility of each scale varies. This presentation used Item Response Theory to assess the quality and utility of the CAINS (Clinical Assessment Interview for Negative Symptoms), BNSS (Brief Negative Symptom Scale), PANSS Negative Factor (Positive and Negative Symptoms Scale), and the NSA-16 (Negative Symptom Assessment-16). Results showed that the BNSS, CAINS and NSA-16 were more informative for subjects with moderate severity, compared to those with low or severe severity levels. In contrast, the PANSS NSFS was equally informative for all levels of severity, although the BNSS and CAINS have distinct conceptual advantages over the PANSS NSF and NSA-16 and captures a broader spectrum of negative symptoms.