CClinicalTrials.gg
CompletedNCT02792296Updated Nov 6, 2016

Feasibility & Characterization of Project: EVO Monitor Cognitive Measurements

An interventional study of Project: EVO Monitor in Healthy, sponsored by Akili Interactive Labs, Inc.. Completed at 2 sites in United States. Open to participants aged 40 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-06.

Sponsored by Akili Interactive Labs, Inc. · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
71
Allocation
Non-randomized
Ages
40 Years to 55 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Akili Interactive Labs, Inc. is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
71 participants (actual)

Study arms

  • Experimental
    Daily measurement

    This arm will be asked to use the Project: EVO Monitor once a day for four weeks..

    Other: Project: EVO Monitor

  • 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

  • Experimental
    Weekly measurement

    This arm will be asked to use the Project: EVO Monitor once a week for eight weeks.

    Other: Project: EVO Monitor

Interventions

  • OtherProject: 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.

06

What researchers measure

Primary outcomes

  1. Feasibility of at-home use as measured by percent of completed assigned sessions

    Time frame: 4 to 8 weeks

07

Study locations

2 sites
  • Preferred Research Partners
    Little Rock, Arkansas 72211, United States
  • Clinical Trials of Texas
    San Antonio, Texas 78229, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02792296
Lead sponsor
Akili Interactive Labs, Inc.
Responsible party
Sponsor
First posted
Jun 7, 2016
Start date
Jun 2016
Primary completion
Nov 2016
Completion
Nov 2016
Last update
Nov 6, 2016

Study contacts

Ted Riley
study director · Promedica International

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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