HealthyNCT02792296
Feasibility & Characterization of Project: EVO Monitor Cognitive Measurements
A study testing Project: EVO Monitor in people with Healthy, run by Akili Interactive Labs, Inc. at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 40 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Project: EVO Monitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2016to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Preferred Research Partners
Little Rock, Arkansas, 72211
Clinical Trials of Texas
San Antonio, Texas, 78229
About this study
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
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.
- Conditions
- Healthy
- Being tested
- Project: EVO Monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project: EVO MonitorOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Daily measurement | Experimental | This arm will be asked to use the Project: EVO Monitor once a day for four weeks.. Receives: Other: Project: EVO Monitor |
| Multiple times per day measurement | Experimental | 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. Receives: Other: Project: EVO Monitor |
| Weekly measurement | Experimental | This arm will be asked to use the Project: EVO Monitor once a week for eight weeks. Receives: Other: Project: EVO Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of at-home use as measured by percent of completed assigned sessions
Measured: 4 to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akili Interactive Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ted Riley, Study director, Promedica International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792296
- Sponsor's protocol ID
- Akili-026
- Status last verified
- Nov 2016
- First submitted
- 2 Jun 2016
- Last updated
- 7 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02792296
- Acronym / sponsor ID
- Akili-026
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Akili Interactive Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 7 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Daily measurement | Experimental | Other: Project: EVO MonitorThis arm will be asked to use the Project: EVO Monitor once a day for four weeks.. |
| Multiple times per day measurement | Experimental | Other: Project: EVO MonitorThis 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. |
| Weekly measurement | Experimental | Other: Project: EVO MonitorThis arm will be asked to use the Project: EVO Monitor once a week for eight weeks. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project: EVO MonitorProject: 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. | Other | Daily measurement, Multiple times per day measurement, Weekly measurement |
Primary outcome
Feasibility of at-home use as measured by percent of completed assigned sessions
Time frame: 4 to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ted Riley study director
Promedica International
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project: EVO Monitor in people with Healthy, run by Akili Interactive Labs, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of at-home use as measured by percent of completed assigned sessions (time frame: 4 to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2016.