Digital Medicine

15 years in the making

2005

Lumos Labs is founded.

2012

Ongoing research collaborations are formalized and named The Human Cognition Project.

2021

Launch of Lumosity DTx, a new division focused on the development of digital medicine.

Lumosity DTx is a new division focused on applying our proprietary technology to the development of treatment, diagnostic, and monitoring tools for neurological and cognitive conditions. This represents a natural extension of our founding mission and everything we have accomplished to date by combining unique insights from Lumosity’s dataset with a growing body of published research.

Building Lumosity was the first step, and since 2007, our brain training program has attracted more than 100 million members to complete over 7.5 billion cognitive exercises. All that activity supports the Human Cognition Project (HCP), which now offers the world’s largest and richest data set on cognitive performance, and serves as the basis for over 80 peer-reviewed articles from more than 100 research collaborations.

Among that work, while Lumosity has not been approved to diagnose, treat, cure, or prevent any disease, our software has been used for studies in 19 clinical populations, including ADHD, mild cognitive impairment, stroke, and traumatic brain injury. These studies give us optimism that components of Lumosity may be applied to the development of FDA-cleared digital medicine.

In particular, we’re excited to explore two medical applications for our software:

  1. Digital Therapeutics (DTx) – a category of digital medicine that deliver medical interventions directly to patients.

  2. Biomarkers – the use of quantitative behavioral or physiological measures to help predict, diagnose, or monitor medical conditions or health-related events.

Adult ADHD: Our first Digital Therapeutic

Among the many conditions that may benefit from Digital Therapeutics (DTx), Lumosity DTx has identified adult ADHD as a first application of the company’s science and technology.

Attention-Deficit Hyperactivity Disorder (ADHD) is a chronic condition affecting millions of Americans.

It is marked by impairments in attention and other cognitive processes. Although ADHD is often diagnosed in childhood, symptoms can persist through adulthood, and adult ADHD remains under-diagnosed. The primary treatments for ADHD — stimulant medications — are controlled substances that can have undesired side effects. More options for treating ADHD, especially non-pharmacological options, are needed.

Along with this unmet need, the breadth of Lumosity tasks targeting aspects of Attention, Cognitive Flexibility, and Working Memory provides an exciting, new approach to the treatment of ADHD. Lumosity DTx has developed a candidate DTx product tailored specifically to the needs of patients with ADHD, and a pivotal clinical trial is underway to evaluate its efficacy and safety. Pending the clinical results, Lumosity DTx plans to seek clearance from the FDA to offer this product as a prescription DTx for the treatment of adult ADHD.

Exploring Lumosity as a biomarker tool

Digital biomarkers include quantitative behavioral or physiological measures that can help predict, diagnose, or monitor medical conditions or health-related events. Because digital biomarkers can be collected from smartphones or wearable devices, they carry the promise of low-cost, high-accessibility, real-world relevance, and convenience.

Preliminary studies suggest that Lumos Labs technology and science might be used to develop digital biomarkers, especially for diagnosis or monitoring. Lumosity DTx has joined the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium and is conducting additional research toward the development of FDA-qualified digital biomarkers.

Product pipeline

Product Candidate or Target¹ Number of Supporting Publications² Stage of Development³
ADHD2Pivotal
Mild Cognitive Impairment (MCI)5Proof of concept
Post-Operative Delirium4Proof of concept
Stroke4Proof of concept
Alzheimer’s Disease (AD)3Proof of concept
Cancer or Chemofog3Proof of concept
Multiple Sclerosis (MS)3Proof of concept
Traumatic Brain Injury (TBI)2Proof of concept
Autism Spectrum Disorder (ASD)1Discovery
Posttraumatic Stress Disorder (PTSD)1Discovery
Schizophrenia1Discovery

¹ Product Candidates are under development at Lumos Labs and have not been evaluated for safety or effectiveness by the US Food and Drug Administration (FDA). The development process is uncertain and these candidates may not become commercial products in the future.

² Supporting publications include peer-reviewed articles conducted by Lumos Labs scientists and/or using Lumos Labs software that support the development of the DTx technology, characterization of the clinical population, and/or investigations of feasibility or efficacy.

³ Stage of Development:

  • Pivotal: the phase in which the product candidate is tested in a clinical trial designed to support market authorization from a regulatory authority such as FDA. Pivotal stage activities include technical work, study design, operational clinical trial activities, and statistical analysis that is part of a regulatory submission.

  • Proof of Concept: the early clinical development stage in which a product candidate is tested in human clinical trials designed to prove that the candidate concept is worthy of advancement to the Pivotal stage. POC stage activities include technical work, study design, operational clinical trial activities, and statistical analysis.

  • Discovery: the concept stage in which the product candidate, its mechanism of action, and target patient population are defined, technical capabilities and prototypes are built.

Relevant literature

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    Walter, S., Clanton, T. B., Langford, O. G., Rafii, M. S., Shaffer, E. J., Grill, J. D., ... & Aisen, P. S. (2020). Recruitment into the Alzheimer Prevention Trials (APT) Webstudy for a Trial-Ready Cohort for Preclinical and Prodromal Alzheimer’s Disease (TRC-PAD). The Journal of Prevention of Alzheimer's Disease, 7(4), 219-225. doi:10.14283/jpad.2020.46

    Weiner, M. W., Nosheny, R., Camacho, M., Truran‐Sacrey, D., Mackin, R. S., Flenniken, D., ... & Veitch, D. (2018). The Brain Health Registry: an internet‐based platform for recruitment, assessment, and longitudinal monitoring of participants for neuroscience studies. Alzheimer's & Dementia, 14(8), 1063-1076. doi:10.1016/j.jalz.2018.02.021

  • Shahmoradi L, Mohammadian F, Rahmani Katigari M. A Systematic Review on Serious Games in Attention Rehabilitation and Their Effects. Behav Neurol. 2022 Feb 26;2022:2017975. doi: 10.1155/2022/2017975. PMID: 35256889; PMCID: PMC8898139.

    Thomas, K.N., & Bardeen, J.R. (2020). The buffering effect of attentional control on the relationship between cognitive fusion and anxiety. Behaviour Research and Therapy, 132, 103653.doi:10.1016/j.brat.2020.103653

  • Han, Y. M., Chan, M. M., Shea, C. K., Lai, O. L. H., Krishnamurthy, K., Cheung, M. C., & Chan, A. S. (2022). Neurophysiological and behavioral effects of multisession prefrontal tDCS and concurrent cognitive remediation training in patients with autism spectrum disorder (ASD): A double-blind, randomized controlled fNIRS study. Brain Stimulation, 15(2), 414-425.

  • Gooch, M., Mehta, A., John, T., Lomeli, N., Naeem, E., Mucci, G., ... & Torno, L. (2021). Feasibility of Cognitive Training to Promote Recovery in Cancer-Related Cognitive Impairment in Adolescent and Young Adult Patients. Journal of Adolescent and Young Adult Oncology. doi: 10.1089/jayao.2021.0055

    Kesler, S., Hosseini, S.H., Heckler, C., Janelsins, M., Palesh, O., Mustian, K., & Morrow, G. (2013). Cognitive training for improving executive function in chemotherapy-treated breast cancer survivors. Clinical breast cancer, 13(4), 299-306. doi:10.1016/j.clbc.2013.02.004

    Kesler, S.R., Lacayo, N.J., & Jo, B. (2011). A pilot study of an online cognitive rehabilitation program for executive function skills in children with cancer-related brain injury. Brain Injury, 25(1), 101-112. doi:10.3109/02699052.2010.536194

  • Geyer, J., Insel, P., Farzin, F., Sternberg, D., Hardy, J. L., Scanlon, M., ... & Weiner, M. W. (2015). Evidence for age-associated cognitive decline from internet game scores. Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring, 1(2), 260-267.

    Tartaglione, E. V., Derleth, M., Yu, L., & Ioannou, G. N. (2014). Can computerized brain training games be used to identify early cognitive impairment in cirrhosis?. Official journal of the American College of Gastroenterology| ACG, 109(3), 316-323.

  • Doraiswamy, P. M., Goldberg, T. E., Qian, M., Linares, A. R., Nwosu, A., Nino, I., ... & Devanand, D. P. (2022). Validity of the web-based, self-directed, neurocognitive performance test in mild cognitive impairment. Journal of Alzheimer's Disease, (Preprint), 1-6.

    Beishon, L. C., Panerai, R. B., Budgeon, C., Subramaniam, H., Mukaetova-Ladinska, E., Robinson, T. G., & Haunton, V. J. (2021). The Cognition and Flow Study: A Feasibility Randomized Controlled Trial of the Effects of Cognitive Training on Cerebral Blood Flow. Journal of Alzheimer's Disease, 80(4):1567-1581. doi: 10.3233/JAD-201444.

    Nguyen L, Murphy K, Andrews G. A Game a Day Keeps Cognitive Decline Away? A Systematic Review and Meta-Analysis of Commercially-Available Brain Training Programs in Healthy and Cognitively Impaired Older Adults. Neuropsychol Rev. 2021 Jul 12. doi: 10.1007/s11065-021-09515-2. Epub ahead of print. PMID: 34251578.

    Dannhauser, T.M., Cleverley, M., Whitfield, T.J., Fletcher, B.C., Stevens, T., & Walker, Z. (2014). A complex multimodal activity intervention to reduce the risk of dementia in mild cognitive impairment–ThinkingFit: pilot and feasibility study for a randomized controlled trial. BMC psychiatry, 14(1), 1-9. doi:10.1186/1471-244X-14-129

    Finn, M., & McDonald, S. (2011). Computerised cognitive training for older persons with mild cognitive impairment: a pilot study using a randomised controlled trial design. Brain Impairment, 12(3).

  • Shaw, M., Pilloni, G., & Charvet, L. (2020). Delivering Transcranial Direct Current Stimulation Away from Clinic: Remotely Supervised tDCS. Military Medicine, 185, 319–325. doi:10.1093/milmed/usz348

    Charvet, L., Shaw, M., Dobbs, B., Frontario, A., Sherman, K., Bikson, M., ... Kasschau, M. (2018). Remotely Supervised Transcranial Direct Current Stimulation Increases the Benefit of At-Home Cognitive Training in Multiple Sclerosis. Neuromodulation, 21(4), 383–389. doi:/10.1111/ner.12583

    Stuifbergen, A. K., Becker, H., Perez, F., Morrison, J., Brown, A., Kullberg, V., & Zhang, W. (2018). Computer-assisted cognitive rehabilitation in persons with multiple sclerosis: Results of a multi-site randomized controlled trial with six month follow-up. Disability and health journal, 11(3), 427-434.

  • Humeidan, M.L., Reyes, J.C., Mavarez-Martinez, A., Roeth, C., Nguyen, C.M., Sheridan, E., ... Bergese, S.D. (2020). Effect of Cognitive Prehabilitation on the Incidence of Postoperative Delirium Among Older Adults Undergoing Major Noncardiac Surgery: The Neurobics Randomized Clinical Trial. JAMA Surg. Published online November 11, 2020. doi:10.1001/jamasurg.2020.4371

    O’Gara, B.P., Mueller, A., Gasangwa, D.V.I., Patxot, M., Shaefi, S., Khabbaz, K., ... & Subramaniam, B. (2020). Prevention of early postoperative decline: a randomized, controlled feasibility trial of perioperative cognitive training. Anesthesia & Analgesia, 130(3), 586-595. doi:10.1213/ANE.0000000000004469

    Bell, C. F., Warrick, M. M., Gallagher, K. C., & Baregamian, N. (2018). Neurocognitive performance profile postparathyroidectomy: a pilot study of computerized assessment. Surgery (United States), 163(2), 457–462. doi:10.1016/j.surg.2017.09.001

    Humeidan, M.L., Otey, A., Zuleta-Alarcon, A., Mavarez-Martinez, A., Stoicea, N., & Bergese, S. (2015). Perioperative Cognitive Protection - Cognitive Exercise and Cognitive Reserve (The Neurobics Trial): A Single-blind Randomized Trial. Clinical Therapeutics, 37(12), 2641–2650. doi:10.1016/j.clinthera.2015.10.013

  • Ben-Zion, Z., Fine, N.B., Keynan, N.J., Admon, R., Green, N., Halevi, M., ... Shalev, A.Y. (2018). Cognitive flexibility predicts PTSD symptoms: Observational and interventional studies. Frontiers in Psychiatry, 9(OCT), 1–9. doi:10.3389/fpsyt.2018.00477

  • Ho, H. Y., Chen, M. D., Tsai, C. C., & Chen, H. M. (2022). Effects of computerized cognitive training on cognitive function, activity, and participation in individuals with stroke: A randomized controlled trial. NeuroRehabilitation, (Preprint), 1-11.

    Withiel, T.D., Sharp, V.L., Wong, D., Ponsford, J.L., Warren, N., & Stolwyk, R. J. (2020). Understanding the experience of compensatory and restorative memory rehabilitation: A qualitative study of stroke survivors. Neuropsychological Rehabilitation, 30(3), 503–522. doi:10.1080/09602011.2018.1479275

    Withiel, T.D., Wong, D., Ponsford, J.L., Cadilhac, D.A., & Stolwyk, R. J. (2020). Feasibility and effectiveness of computerised cognitive training for memory dysfunction following stroke: A series of single case studies. Neuropsychological Rehabilitation, 30(5), 829–852. doi:10.1080/09602011.2018.1503083

    Wentink, M.M., Berger, M.A.M., de Kloet, A.J., Meesters, J., Band, G.P.H., Wolterbeek, R., ... & Vliet Vlieland, T.P.M. (2016). The effects of an 8-week computer-based brain training programme on cognitive functioning, QoL and self-efficacy after stroke.

  • Hooker, C.I., Carol, E.E., Eisenstein, T.J., Yin, H., Lincoln, S. H., Tully, L. M., ... & Seidman, L. J. (2014). A pilot study of cognitive training in clinical high risk for psychosis: initial evidence of cognitive benefit. Schizophrenia research, 157, 314. doi:10.1016/j.schres.2014.05.034

  • Alosco, M.L., Tripodis, Y., Baucom, Z.H., Mez, J., Stein, T.D., Martin, B., ... Stern, R. A. (2020). The Late Contributions of Repetitive Head Impacts and TBI to Depression Symptoms and Cognitions. doi:10.1212/WNL.0000000000010040

    Zickefoose, S., Hux, K., Brown, J., & Wulf, K. (2013). Let the games begin: A preliminary study using Attention Process Training-3 and Lumosity™ brain games to remediate attention deficits following traumatic brain injury. Brain injury, 27(6), 707-716. doi:10.3109/02699052.2013.775484