Required Application Instructions Applicants should complete the required HCP Application Form and submit electronically to

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1 Funding Opportunity (Spring 2015) FUNDING OVERVIEW Funding Opportunity Title Studying the effects of Lumosity computerized cognitive training on cognitive decline in individuals with Age-Associated Memory Impairment, Mild Cognitive Impairment, or dementia Funding Opportunity Purpose The purpose of this funding opportunity announcement is to stimulate clinical research focused on the use of computerized cognitive training to slow or prevent cognitive decline in individuals with Age-Associated Memory Impairment (AAMI), Mild Cognitive Impairment (MCI), or dementia (e.g., Alzheimer s disease, Parkinson s dementia, vascular dementia, etc.). Additionally, this opportunity can support clinical research that utilizes computerized cognitive assessments (i.e., Lumosity Neurocognitive Performance Test) in assessing treatment outcomes in a research or clinical setting. It is anticipated that the results of these research efforts may provide additional tools to slow or prevent cognitive decline and maintain the ability to perform activities of daily living, or be used to measure benefit for new experimental treatments targeting cognitive impairment. Earliest Submission Date July 1, 2015 Application Closing October 1, 2015; 5:00pm Pacific Time Required Application Instructions Applicants should complete the required HCP Application Form and submit electronically to grants@lumoslabs.com. The Research Plan should include sufficient information needed for evaluation of the project, independent of any other document (e.g., previous application). Be specific and informative, and avoid redundancies. The Research Plan should also include a discussion of controls, study outcomes, study duration, and study power that is mindful of the potential effect sizes and number of subjects. FULL OPPORTUNITY DESCRIPTION Purpose Memory loss is a prominent health concern, second only to heart disease for older individuals, and is one of the most costly aspects of aging. Subjective concerns about memory may be an early sign for eventual cognitive decline and correlated with pathological changes in Alzheimer s Disease (AD) biomarkers. AD is the most common cause of dementia in North America and is the sixth leading cause of death in the United States. According to the Alzheimer s Association, in 2011 an estimated 5.4 million people in the United States had AD with 5.2 million aged 65 and over and 200,000 younger than 65 years of age. In the US, aggregated direct costs of AD are expected to rise from $183 billion dollars in 2011 to $1.1 trillion in Recent reports estimate that the age-specific incidence of age-related cognitive impairment is approximately double that of dementia and affects 15% 25% of older individuals. Page 1 of 4

2 Funding Opportunity (Spring 2015) Drug discovery and development in AD and related dementias is now focused on treatments that target the fundamental pathology prior to the emergence of symptoms in hopes that treating early has the potential to yield the greatest benefits to patients. The goal with this treatment paradigm is preventing or slowing disease progression rather than treatment of symptoms. Engagement in cognitively stimulating activities throughout the life span, such as computerized cognitive training, may enhance late-life cognition, reduce cognitive burden, and reduce risk of cognitive impairment and dementia. The goal of this funding opportunity is to stimulate clinical research to 1) test the effectiveness of cognitive brain training as a non-pharmacological approach, either alone or in combination with pharmacological treatments, to slow or prevent cognitive decline in individuals with Age-Associated Memory Impairment (AAMI), Mild Cognitive Impairment (MCI), or dementia (e.g., Alzheimer s disease, Parkinson s dementia, vascular dementia, etc.), 2) inform on the utility of this approach as a feasible addition or alternative to pharmacological treatments, 3) elucidate the neural correlates of cognitive brain training, and 4) determine the effectiveness of computerized cognitive assessments for detecting treatment effects and/or benefits. The funding opportunity is particularly interested in unsupervised, remote, implementation of computerized cognitive training and computerized assessments. Research Objectives Research objectives include, but are not limited to, those that address: Lumosity cognitive training as a non-pharmacological, pro-cognitive intervention in individuals with AAMI, MCI, or dementia (e.g., Alzheimer s disease, Parkinson s dementia, vascular dementia, etc.) to slow or prevent cognitive decline The long-term effects of Lumosity cognitive training, alone, or in combination with pharmacological treatments The long-term effects of Lumosity cognitive training, alone, or in combination with other modifiable lifestyle and environmental factors that have been shown to affect cognitive decline (e.g., sleep, nutrition, physical activity) Brain changes and neural correlates impacted by Lumosity cognitive training Utility and feasibility of Lumos Labs Neurocognitive Performance Test as an assessment tool to measure treatment effects and/or benefits Lumosity cognitive training and cognitive testing implemented in an unsupervised, at home environment Background Lumosity is committed to pioneering the understanding and enhancement of the human brain. Lumosity's online and mobile programs are composed of a wide variety of cognitive training tasks that are presented in game-like formats to train core cognitive abilities including memory, attention, speed of processing, problem solving, and mental flexibility. Lumosity now has more than 40 games, 70 million members, and users from 180 countries and its cognitive training tasks have been played more than 2 billion times. Recent evidence suggests that engaging in cognitively challenging activities can positively impact brain function, with studies demonstrating behavioral, physiological, and real-world functional gains. To this end, Lumosity includes a variety of cognitive training programs that have been developed with activities designed to elicit enhancements in cognitive abilities through intensive, repetitive mental exercise, with promising results for improving cognition and functioning following training reported in many cases. Prior studies of varying sizes and designs that used Lumosity have measured improvements in cognition in healthy older adults; healthy middle-aged adults; older adults with MCI; children with Turner s Syndrome; pediatric cancer survivors; and adult survivors of breast cancer (see the bibliography at lumosity.com/hcp) Page 2 of 4

3 Funding Opportunity (Spring 2015) The design principles of Lumosity were chosen to maximize the potential for transferring performance improvements beyond the tasks at hand to underlying core cognitive abilities. To this end the Neurocognitive Performance Test was developed as a brief, repeatable, computerized battery of cognitive assessments to measure functioning in five cognitive domains across time: memory, processing speed, problem solving, attention, and flexibility. The subtests were designed to be faithful computerized replications of validated pencil-and-paper tests, where shifting to computerized administration would not affect the test mechanic. Evidence from several investigations on the Neurocognitive Performance Test provide good support for the validity, reliability, and sensitivity of the assessment and support its use as a measure of cognitive ability. The Neurocognitive Performance Test has demonstrated good concordance with pencil-and-paper neuropsychological tests, good test-retest reliability, and is sensitive to change, with more training leading to better performance. AWARD INFORMATION Duration of Funding Award Budget Number of Awards Eligibility Up to 3 years as determined by the project scope with the potential for extension Up to $500,000 in total costs (direct and indirect) for the entire project period of up to 3 years, with the potential for extension. Funds will be allocated annually on a pro rata basis and subject to project updates and review. Funds are to be used to cover research expenses only and cannot be used for equipment, supplies, travel, conference or publication costs. A single proposal will be funded Individuals from academic, medical, or research institutions are eligible to apply. Individuals from industry, including CROs, are not eligible. Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. APPLICATION REVIEW INFORMATION Criteria Overall Impact Scored Review Criteria Only the review criteria described below will be considered in the review process. All applications are evaluated for scientific and technical merit through an internal review system. Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to make an important scientific contribution to the research field and advance the understanding of cognitive brain training. Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. a) Project Relevance Is the project Lumosity-focused? If the objectives of the project are met, how will they impact scientific knowledge, technical Page 3 of 4

4 Funding Opportunity (Spring 2015) capabilities, and/or clinical practice? b) Investigator(s) Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-pd/pi, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Is the institution credible and likely to provide the necessary support? c) Study Design and Approach Are the overall strategy, methodology, outcome measures, and analyses well reasoned and appropriate to accomplish the specific objectives of the project? Does the study have a clear research question and hypothesis? Does the study design represent a clear approach to address the research question? Is the study adequately powered? Is there an appropriate control group? Are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, described and justified in terms of the scientific goals and research strategy proposed? d) Analysis Plan Does the study have an appropriate analysis plan? Are the outcome measures relevant to the study? REVIEW AND SELECTION PROCESS Applications will be evaluated for scientific and technical merit by an internal panel. As part of the internal review process, only applications deemed to have the highest scientific and technical merit will be discussed, assigned an overall impact score, and may receive a written critique. After initial review, the following will be considered in making the final funding decision: - Availability of funds - Scientific and technical merit of the proposed project as determined by scientific peer review - Relevance of the proposed project to overall research priorities Award Notice A formal notification will be provided to the successful applicant no later than February 1, Any costs incurred before receipt of formal notification is at the recipient s expense and will not be reimbursed. Any application awarded in response to the funding opportunity will be subject to the terms and conditions of the Lumos Labs Service Agreement Additional information may be obtained via to: grants@lumoslabs.com Page 4 of 4

5 Research Application Form (LLHCP.001) Effective Date ( ) APPLICANT INFORMATION Prefix Name Title Institution Department Contact Phone Contact PROJECT INFORMATION Project Title Primary Hypothesis Subject Population (e.g., healthy volunteers, Alzheimer s, etc.) Age Range Planned Enrollment (Specify total number of participants and number per group) Page!1!of!5!!

6 Research Application Form (LLHCP.001) Effective Date ( ) Primary Objective Secondary Objective(s) Experimental Condition Control Condition Study Description (Provide an overview of the study design) Page!2!of!5!!

7 Research Application Form (LLHCP.001) Effective Date ( ) Study Description (cont). Page!3!of!5!!

8 Research Application Form (LLHCP.001) Effective Date ( ) Primary Outcome Measure Secondary Outcome Measure(s) Proposed Timeline Planned Study Start: Month/Day/Year Planned Study Completion: Month/Day/Year Analysis Plan (Include power calculation and rationale for sample size) Page!4!of!5!!