Feasibility & Characterization of Project: EVO Monitor Cognitive Measurements

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT02792296
• Lead Sponsor: Akili Interactive Labs, Inc.

Brief 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.

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 Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-02
• Study First Submitted QC: 2016-06-06
• Study First Posted: 2016-06-07
• Status Verified: 2016-11
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Last Update Submitted: 2016-11-03
• Last Update Posted: 2016-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility of at-home use as measured by percent of completed assigned sessions	4 to 8 weeks

Trial Locations

Locations (2)

Clinical Trials of Texas; 🇺🇸 San Antonio, Texas, United States

Preferred Research Partners; 🇺🇸 Little Rock, Arkansas, United States