EndeavorRxTM: The first-and-only FDA-cleared treatment delivered through a video game experience
EndeavorRx is available in 3-month treatment periods, during which your child will use the treatment as prescribed by a healthcare professional.
The EndeavorRx app is a digital treatment 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 and should be considered for use as part of a therapeutic program.
EndeavorRx is an FDA-cleared medical device and must be prescribed by a healthcare professional. It is not intended as a stand-alone therapeutic, nor is it a substitute for your child’s medication.
A prescription for EndeavorRx provides an initial 3-month access to the treatment, as well as Akili CareTM to support you on your journey. EndeavorRx is not covered by health insurance, but we’re actively working to improve health insurance coverage. In the interim, we’re able to offer a lower price than our standard price of $450 for 3-month prescription access through our online pharmacy. If you’re not able to pay for EndeavorRx, Akili may be able to help. Visit AkiliAssist.com to learn more.
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Experienced through an immersive and challenging digital therapy on an Apple iOS mobile device
Proprietary and patented technology adapts real-time and between treatment sessions to your child’s level, continuously challenging and encouraging them to improve their performance
Prescribed by your child’s healthcare professional and used alongside your current treatment plan
At Akili, we understand the impact of inattention on children and families. To help address this problem, our team of world-class neuroscientists and video game designers collaborated to strive to improve attention in a truly unique way.
Evaluated in over 600 children with ADHD across 5 clinical studies1, the EndeavorRx treatment 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 your child 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.
In a controlled clinical trial, EndeavorRx demonstrated a significant improvement in a computer-based measure of attention (TOVA® API) compared to a digital control word game.
In our randomized, controlled clinical study, EndeavorRx improved objective attention in children with ADHD ages 8-12. In addition, 48% of parents indicated that EndeavorRx improved ADHD-related day-to-day impairment and 56% of parents indicated the treatment improved their child's attention.2
In an open-label study, 68% of parents reported improvement in ADHD-related impairments after a second month of EndeavorRx. In addition, up to one third of children had a clinically meaningful change in ADHD symptoms after one month of treatment with EndeavorRx; this increased to 45% after a second month of treatment. These effects were similar whether children were on or off ADHD medication.3
There were no serious adverse events seen in any clinical trials of EndeavorRx. Of 538 participants using EndeavorRx in clinical trials, 50 participants (9.3%) experienced treatment-related adverse events. EndeavorRx associated adverse events included frustration (6.1%), headache (1.3%), dizziness (0.6%), emotional reaction (0.4%), nausea (0.4%), and aggression (0.2%).
1STARS-ADHD Pivotal Study: Kollins et al, Lancet Digital Health, 2020. STARS-Adjunctive Study: Data on File, Akili, 2020. (manuscript in progress). Proof of concept study: Davis et al, PLOS One, 2018. Pilot studies: Anguera et al., PLOS One, 2017. Yerys et al., J Autism Dev Disord, 2019
2STARS-ADHD Pivotal Study: Kollins et al, Lancet Digital Health, 2020.
3STARS-Adjunctive Study: Data on File, Akili, 2020. (manuscript in progress).
It's important to know that EndeavorRx might feel repetitive and challenging for some children at times, and it takes commitment from you and your child to see results. Although there are exciting rewards and motivational elements designed into the treatment, you should expect tough moments on the path to improving your child’s attention. But, making this part of your family’s routine can help. Remember: you and your child can do this, and we’re here to help.
Here are some treatment tips to help guide you and your child through the EndeavorRx experience.
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 ADHD. EndeavorRx is not intended to be used as a stand-alone therapeutic and is not a substitute for your child’s ADHD medication.
You should contact your child’s healthcare professional and review the important indications, safety and cautions information in the Instructions for Use before using the EndeavorRx treatment.
The views and opinions expressed in these videos are unique to the parents featured and not necessarily representative of Akili's views.
In the 5-minute demo, you can expect your character to navigate through ‘Planet Frigidus,’ and tap and steer in order to progress and earn rewards. This demo should provide you with a better understanding of the EndeavorRx gameplay mechanics and overall experience. The demo is for look and feel only, and does not contain any therapeutic benefit. It should not be used as a substitute for the actual EndeavorRx treatment.
Use this guide to start a conversation with your child’s healthcare professional about EndeavorRx.
A prescription for EndeavorRx provides an initial 3-month access to the treatment, as well as Akili Care to support you on your journey. EndeavorRx is not covered by health insurance, but we’re actively working to improve health insurance coverage. In the interim, we’re able to offer a lower price than our standard price of $450 for 3-month prescription access through our online pharmacy. If you’re not able to pay for EndeavorRx, Akili may be able to help. Visit AkiliAssist.com to learn more.
Indications for Use:
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.
Cautions:
Rx only: Federal law restricts this device to sale by or on the order of a physician.
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.
Safety:
Of 538 participants using EndeavorRx, 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. EndeavorRx associated adverse events included frustration (6.1%), headache (1.3%), dizziness (0.6%), emotional reaction (0.4%), nausea (0.4%), and aggression (0.2%). There were no serious adverse events. All adverse events were generally transient. Only 3 events led to device discontinuation, and no subject reported lasting or irreversible effects after discontinuation.
Indications for Use:
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, Tests 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.
Cautions:
Rx only: Federal law restricts this device to sale by or on the order of a physician.
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.
Safety:
Of 538 participants using EndeavorRx, 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. EndeavorRx associated adverse events included frustration (6.1%), headache (1.3%), dizziness (0.6%), emotional reaction (0.4%), nausea (0.4%), and aggression (0.2%). There were no serious adverse events. All adverse events were generally transient. Only 3 events led to device discontinuation, and no subject reported lasting or irreversible effects after discontinuation.