Feasibility & Characterization of Project: EVO Monitor Cognitive Measurements

A Study to Assess the Feasibility of and to Characterize Project: EVO Monitor Cognitive Function Measurements When Played Daily, Weekly, or Multiple Times Per Day in Adults 40-55 Years Old

This is an open-label study in adults to assess at-home Project: EVO Monitor measurements over repeat play cycles. The study has three arms:playing multiple times per day, once daily, and once weekly for 4 to 8 weeks.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Project: EVO Monitor

Detailed Description

This is an open-label study in adults ages 40 to 55 to assess Project: EVO Monitor measurements over repeat play cycles. The study has three arms: adults playing multiple times per day, adults playing once daily, and adults playing once weekly. The investigators plan to evaluate 76 participants (N = 30 in the daily and weekly arms, and N=16 in the multiple times per day arm) in two sites over a 4 to 8 week study period. The study period includes 2 in-clinic sessions and scheduled, at-home game play of the short (less than 7 minutes) Project: EVO Monitor.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Preferred Research Partners
  • Texas
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age: 40-55 at the time of informed consent
• Ability to follow written and verbal instructions (English).
• Male and Female (Gender-matched).
• Ability to comply with all the testing and requirements.

Exclusion Criteria:

• Current, controlled (requiring a restricted medication) or uncontrolled, self-reported psychiatric diagnosis with significant symptoms such as post-traumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder, conduct disorder, attention deficit disorder, autism spectrum disorder, or other symptomatic manifestations that in the opinion of the Investigator that may confound study data/assessments.
• Current self-reported community diagnosis of cognitive ailments such as dementia, Alzheimer's disease, stroke, traumatic brain injury, or other diseases that in the opinion of the Investigator that may confound study data/assessments.
• Current diagnosis of severe learning disorder, dyslexia, or dyscalculia.
• Current subjective complaints of inattention or memory loss.
• Current use of psychotropic medication, prescription or otherwise.
• Currently undergoing psychotherapy, behavioral therapy, or occupational therapy.
• Motor condition that prevents game playing, as observed by investigator.
• Impaired visual acuity, as defined by difficulty reading the informed consent even with corrective lenses.
• Recent history (within the past 6 months) of suspected substance abuse or dependence.
• History of seizures (exclusive of febrile seizures), a tic disorder, significant tics, a current diagnosis of Tourette's Disorder.
• Taken part in a clinical trial within 30 days prior to screening.
• Diagnosis of color blindness.
• Regular use of psychoactive drugs that in the opinion of the Investigator may confound study data/assessments
• Any other medical condition that in the opinion of the investigator may confound study data/assessments.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Daily measurement; This arm will be asked to use the Project: EVO Monitor once a day for four weeks..	Other: Project: EVO Monitor; Project: EVO Monitor was designed to incorporate a proprietary multi-tasking assessment into a state-of-the-art mobile video game-like platform, which deploys modern videogame graphics, engaging reward loops, and real-time adaptive mechanics to dynamically personalize difficulty in order to assess the user's ability.
EXPERIMENTAL: Multiple times per day measurement; This arm will be asked to use the Project: EVO Monitor at least once per day and six times over the day every three days for four weeks.	Other: Project: EVO Monitor; Project: EVO Monitor was designed to incorporate a proprietary multi-tasking assessment into a state-of-the-art mobile video game-like platform, which deploys modern videogame graphics, engaging reward loops, and real-time adaptive mechanics to dynamically personalize difficulty in order to assess the user's ability.
EXPERIMENTAL: Weekly measurement; This arm will be asked to use the Project: EVO Monitor once a week for eight weeks.	Other: Project: EVO Monitor; Project: EVO Monitor was designed to incorporate a proprietary multi-tasking assessment into a state-of-the-art mobile video game-like platform, which deploys modern videogame graphics, engaging reward loops, and real-time adaptive mechanics to dynamically personalize difficulty in order to assess the user's ability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Feasibility of at-home use as measured by percent of completed assigned sessions	4 to 8 weeks

Collaborators and Investigators

• Sponsor: Akili Interactive Labs, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (ACTUAL): November 1, 2016
• Study Completion (ACTUAL): November 1, 2016

Study Registration Dates

• First Submitted: June 2, 2016
• First Submitted That Met QC Criteria: June 6, 2016
• First Posted (ESTIMATE): June 7, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): November 6, 2016
• Last Update Submitted That Met QC Criteria: November 3, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: Akili-026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO