FAQ

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General

What is the EndeavorRx treatment and what is it used for?

EndeavorRx is a prescription digital therapeutic intended to improve attention function in children 8-12 with primarily inattentive or combined-type ADHD who have a demonstrated attention issue. It is the first FDA-authorized ADHD treatment delivered through a video game, and targets areas of the brain that play a key role in attention function. EndeavorRx must be prescribed by a doctor.

Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure, Test of Variables of Attention (TOVA®), of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity.

How does EndeavorRx work?

EndeavorRx uses sensory stimuli and simultaneous motor challenges designed to target areas of the brain that play a key role in attention function. When using EndeavorRx, the goal is for the patient to successfully navigate their character through a course while collecting targets and avoiding bumping into obstacles. These actions require focus and flexibility to manage multiple tasks at the same time.

How is EndeavorRx different from a non-prescription video game?

The treatment programmed into the game was designed to challenge a patient’s attentional control during gameplay, requiring focus and flexibility to manage multiple tasks at the same time. The game adapts in real-time as well as between treatment sessions, continuously challenging and encouraging the patient to improve their performance – individualizing to each patient’s experience.

Why is EndeavorRx only available by prescription?

EndeavorRx is only available by prescription because it is an FDA-authorized medical device, designed for the treatment of a medical disorder. It is a digital therpeutic that has been evaluated in over 600 children with ADHD across 5 clinical studies. It uses proprietary and patented technology that targets key neural systems in the brain related to attentional control.

How can I download and access the demo?

You can try a brief, playable demo to experience the look and feel of EndeavorRx. To access the demo, download the EndeavorRx app in the App Store® or on Google Play™. Once you open the app, just click “Play Demo” to get started. This demo is for look and feel only, and does not contain any therapeutic benefit. This demo should not be used as a substitute for the actual EndeavorRx treatment.

I’m a physician and have questions about EndeavorRx. Who can I consult?

If you’d like to schedule a meeting with one of our product experts to learn more about EndeavorRx, you can Contact a Representative here.

Additionally, if you have questions regarding prescribing the treatment, can contact Akili Assist® at (844) 254-5447 Monday to Friday: 9am-9pm EST.

What is Selective Stimulus Management Engine (SSME™)?

SSME is a proprietary & patented technology that presents specific sensory stimuli and simultaneous motor challenges designed to target key neural systems in the brain related to attentional control.

SSME technology implements specific closed-loop algorithms that adapt real-time and between treatment sessions to automatically adjust the difficulty level for a personalized treatment experience. The algorithms enable second by second monitoring of patient progress, and continuously challenge each patient to an optimized level, encouraging them to improve their performance.

Will my patient enjoy playing EndeavorRx?

EndeavorRx is different from other action video games that a child might play. While it can be fun and rewarding at times, it can also feel challenging and repetitive, by design, at others. The treatment programmed into the gameplay experience was designed to challenge a child’s attentional control during gameplay, requiring focus and flexibility to manage tasks at the same time.

Clinical

Do you have any long-term/durability data?

At this time, Akili has the 12-week, open label, STARS Adjunct study in which participants played EndeavorRx for 4 weeks, followed by a treatment pause for 4 weeks, followed by an additional 4 weeks of EndeavorRx therapy. (Please refer to graphs of STARS Adjunct study for elaboration.)

What is the Test of Variables of Attention (TOVA®) and why did you use this measure?

The Test of Variables of Attention (TOVA®), is an objective and accurate computer-based test to measure the key components of attention and inhibitory control. The visual TOVA aids in the assessment of, and evaluation of treatment for, attention deficits, including ADHD.

Has the EndeavorRx treatment been studied in clinical trials? What were the results?

The 5 clinical studies in over 600 children with ADHD used to support EndeavorRx authorization are:

  • A study of 348 children with ADHD (not receiving ADHD medication), where EndeavorRx was used for a 4-week treatment period, showed improvements in attention function (as measured by computer-based testing) and attention-related ADHD symptoms and impairments.
  • A study of 206 children with ADHD (on stimulant medication or not receiving any ADHD medication), where EndeavorRx was used for a 4-week period, followed by a treatment pause of one month and a subsequent second 4-week treatment period. Improvements in attention-related ADHD symptoms and impairments were similar in magnitude to those seen in other studies and further improved with the second treatment period in children on or off ADHD medication.
  • Three separate studies of 40, 20 and 19 children with ADHD, where EndeavorRx was used for a 4-week treatment period and showed improvements in attention measures and attention-related ADHD symptoms.

Are there any side effects of EndeavorRx?

There were no serious adverse events seen in any clinical trials of EndeavorRx. Of 538 participants in trials supporting EndeavorRx authorization, 50 participants (9.3%) experienced treatment-related adverse events, including frustration (6.1%), headache (1.3%), dizziness (0.6%), emotional reaction (0.4%), nausea (0.4%), and aggression (0.2%).

If your child experiences frustration, emotional reaction, dizziness, nausea, headache, eyestrain, or joint pain while playing EndeavorRx, pause the treatment. If the problem persists, contact your child’s healthcare provider. If your child experiences a seizure, stop the treatment and contact your child’s healthcare provider.

A very small percentage of individuals who play video games may experience epileptic seizures or blackouts when exposed to certain light patterns or flashing lights. Playing video games may trigger epileptic seizures or blackouts in these individuals. These conditions may also trigger previously undetected epilepsy or seizures in persons who have no prior history of epilepsy or seizures. If your child, or anyone in your family, has an epileptic condition or has had seizures of any kind, please consult your child’s physician before using EndeavorRx.

Prescribing Information

How should the EndeavorRx treatment be used?

EndeavorRx is recommended to be used approximately 25 minutes per day, 5 days per week, initially for at least 4 weeks. Unlike an action video game, there is no way to “win” EndeavorRx. The algorithm continues to challenge the patient at a specific and consistent level of difficulty throughout the game. In addition, the multitasking rules get more complex as the game progresses through the four worlds. As long as the patient is playing consistently and trying his/her best, the patient is engaging with the treatment as intended.

Does EndeavorRx have dosing strengths?

While EndeavorRx does not have different ‘strengths’ that are prescribed for different patients like a pharmaceutical, the game’s difficulty will adapt according to the patient’s progress in completing missions.

Is there a way to test out the treatment before prescribing it?

You can try a brief, playable demo to experience the look and feel of EndeavorRx. To access the demo, download the EndeavorRx app in the App Store® or on Google Play™. Once you open the app, just click “Play Demo” to get started. This demo is for look and feel only, and does not contain any therapeutic benefit. This demo should not be used as a substitute for the actual EndeavorRx treatment.

Please note that your patient, along with their caregiver’s help, can also access this demo in the same way.

After EndeavorRx has been purchased, can it be used for more than one child?

No, an EndeavorRx activation code can only be used by the individual for whom it was prescribed. If multiple children in a household have been prescribed EndeavorRx, the caregiver will receive an individual activation code for each child and individual payment request emails for each activation code.

If the caregiver has more than one child prescribed EndeavorRx, their children can still use the same device to play EndeavorRx. However, they will not be able to play at the same time, and will access their personalized treatment on their respsective Akili Accounts.

How long does a prescription last?

An EndeavorRx prescription provides 30 days of treatment once your code is activated.

How much does the EndeavorRx treatment cost?

The cash price for EndeavorRx is $99. If insurance covers EndeavorRx, the out-of-pocket cost will vary based on insurance plan benefits.

Does the caregiver need to sit with the child while using the EndeavorRx treatment?

You may recommend that the caregiver sit with your patient, but it is not necessary. However, we do recommend that the caregiver designate a suitable place free from distractions for the child to play, as well as a time of day. For more advice on making the most of the treatment, you can have the caregiver check out our Treatment Tips.

Can the patient pause during sessions?

Yes, each daily treatment can be paused at any time by tapping the upper-left corner of the screen. Note that there are built-in rest periods between sessions (every four or five minutes on average).

Technical

What devices are compatible with EndeavorRx?

iOS Device Minimum Specifications are:

  • iOS version: 13.0
  • iPadOS® version: 13.1
  • Storage: 16 GB of storage space
  • Memory: 2 GB of RAM
  • Network Infrastructure: WiFi
  • Example Devices: iPad mini® 5, iPhone® 13 Pro, and later models

Android Device Minimum Specifications are:

  • Android OS version: 9.0
  • Storage: 64 GB of storage space
  • Memory: 4 GB of RAM
  • Network Infrastructure: WiFi
  • Example Devices: Samsung® Galaxy S10, Samsung Tab A8 (2022 Model, 4 GB version only), and similar or later models

For more information about device minimum requirements, see our Instructions for Use or visit the EndeavorRx on the App Store® or on Google Play™.

What devices are recommended for EndeavorRx?

Is EndeavorRx available on any EMR platform?

EndeavorRx is available on most EMR platforms. If you are unable to access EndeavorRx on your EMR platform, please reach out to phil.us/contact and Akili will work with the system to have it added.

Does data remain safe and private while the patient uses the EndeavorRx treatment?

Akili understands how important data privacy is to you. Akili uses industry standard privacy and security measures to protect the patient’s health data, in accordance with the terms of Akili’s Privacy Notice for the EndeavorRx treatment located here.

Is an internet connection required to play?

Internet or network connectivity is not required to use the EndeavorRx treatment, but it is required to download, register, activate, and start treatment. Once the patient begins treatment, he or she can use the EndeavorRx treatment online or offline. Akili recommends the patient play the EndeavorRx treatment while connected to WiFi so that the app can stay in sync with important updates.

Other

The EndeavorRx treatment is delivered via a digital screen. Should I be fearful of screen time risks?

We understand that screen time can be of concern to parents and physicians. We are aligned with the American Academy of Pediatrics in its policy on screen time for children.

Daily EndeavorRx treatments last approximately 25 minutes without interruption. Be sure to let your child know that it is okay to occasionally take a break from treatment for a few minutes in order to avoid excess eye strain or fatigue.

I am a Physician outside of the US interested in learning more about EndeavorRx, where can I find more information?

To learn more please reach out to our support and knowledge team, Akili Assist at (844) 254-5447 Monday to Friday: 9am-9pm EST. Please know, as an FDA-authorized medical device, EndeavorRx must be prescribed by a United States licensed physician, and you must be able to access the United States instance of the App Store Or Google Play to download it.

I am a student interested in partaking in research. Where can I learn more information that pertains to me?

We’re glad you’ve taken an interest in our product. Visit clinicaltrials.gov for current trials and recruitment contacts associated with Akili.

EndeavorRx:

Indications, Safety and Cautions

Indications:
EndeavorRx is a digital therapeutic indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure, Test of Variables of Attention (TOVA®), of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity. EndeavorRx should be considered for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder.

Safety:
No serious adverse events were reported. Of 538 participants in trials supporting EndeavorRx authorization, 50 participants (9.3%) experienced treatment-related adverse events (probable, likely), and three participants experienced treatment-related adverse events with the digital control, in studies where a control was used. Associated adverse events included frustration (6.1%), headache (1.3%), dizziness (0.6%), emotional reaction (0.4%), nausea (0.4%), and aggression (0.2%). All adverse events were generally transient. Only 3 events led to device discontinuation, and no subject reported lasting or irreversible effects after discontinuation.

Cautions:
Rx only: Federal law restricts this device to sale by or on the order of a licensed health care provider. EndeavorRx should only be used by the patient for whom the prescription was written. For medical questions, please contact your child’s healthcare provider. If you are experiencing a medical emergency, please dial 911. EndeavorRx is not intended to be used as a stand-alone therapeutic and is not a substitution for your child’s medication.

If your child experiences frustration, emotional reaction, dizziness, nausea, headache, eye-strain, or joint pain while playing EndeavorRx pause the treatment. If the problem persists contact your child’s healthcare provider. If your child experiences a seizure stop the treatment and contact your child’s healthcare provider.

EndeavorRx may not be appropriate for patients with photo-sensitive epilepsy, color blindness, or physical limitations that restrict use of a mobile device; parents should consult with their child’s healthcare provider.

Please follow all of your mobile device manufacturer’s instructions for the safe operation of your mobile device. For example, this may include appropriate volume settings, proper battery charging, not operating the device if damaged, and proper device disposal. Contact your mobile device manufacturer for any questions or concerns that pertain to your device.