Clinical trial NCT02792296: Feasibility & Characterization of Project: EVO Monitor Cognitive Measurements
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Akili Interactive Labs, Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-07
Enrollment: 71
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of at-home use as measured by percent of completed assigned sessions
timeFrame: 4 to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Preferred Research Partners
state: Arkansas
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
Study officials:
affiliation: Promedica International
name: Ted Riley
role: STUDY_DIRECTOR
References: