Successful conclusion of EU project Alzheimer’s Detect & Prevent with early validation of two Brain+ DTx technologies and extra funding
Company Announcement
Copenhagen, Denmark, February 8, 2023 – Brain+ A/S (Nasdaq First North: BRAINP)
The information communicated in this announcement is “inside information” for the purposes of article 7 of the Market Abuse Regulation 596/2014
- The ‘Alzheimer’s Detect & Prevent’ project, led by Brain+ and funded under the EU Horizon2020 innovation framework, has been approved by the European Commission
- The project has funded the development and early clinical feasibility testing of two key Brain+ technologies: 1) the ‘Starry Night’ cognitive test and 2) 1st generation Computerized Cognitive Training (CCT) for the reduction of mental workload
- The indications of clinical feasibility of the CCT technology and the Starry Night cognitive test provide early support for the company's pipeline ‘CST for MCI’ product for Mild Cognitive Impairment, which combines CCT, Starry Night, and Cognitive Stimulation Therapy (CST)
- The final review by the European Commission resulted in Brain+ securing an additional payment of €110.000 above the original budget to Brain+ for work rendered and results obtained.
The 3.5-year Alzheimer’s Detect & Prevent project (ADDP) funded with €3.5 million by the EU commenced in November 2018 with the objective to develop and validate digital solutions for early detection and prevention of Alzheimer’s disease. In other words, to create ways to identify people early, before Alzheimer’s disease has progressed far and manifested with symptoms, to allow for prompt prevention efforts. The project consists of a strong consortium of partners including the University of Oxford, Nottingham University, Aarhus University, Aarhus University Hospital, Alzheimer Europe, and the European Brain Council. Read more at https://www.addp.eu.
Kim Baden-Kristensen, CEO & Co-founder of Brain+: “The ‘Alzheimer’s Detect & Prevent’ project has been our biggest and most ambitious innovation project to date and has resulted in very valuable additions to our technology and science base that our future products will be based on. Working with top academics and clinicians in this field is both an honor and a pleasure, and we are happy to already be continuing these partnerships in new projects.
2 technologies have been created and tested in 3 clinical trials with promising feasibility results
The project developed and tested two digital technologies that are now part of the Brain+ technology portfolio, 1) The Starry Night cognitive test, and 2) 1st Generation CCT games. Two clinical trials have been conducted by the University of Oxford (link) and the University of Nottingham (link), and a third is finalizing by the University of Aarhus, to test the technologies. The concluded trials showed promising feasibility of both technologies. Read more details about the two technologies, the trials, and the future development plans at the end of this news release.
€110.000 in additional payout
While the entire project benefitted Brain+ by developing and validating its technology portfolio, the Brain+ direct share of the original budget was €2.1 million. At the final financial review, it was deemed that Brain+ was eligible for a combined cost coverage of €2.2 million, resulting in an additional €110.000 payout to Brain+ beyond originally budgeted.
Contact Information
CEO and Co-founder: Kim Baden-Kristensen, + 45 31393317, kim@brain-plus.com
Certified Advisor: Keswick Global AG, + 43 1740408045, info@keswickglobal.com
The mission of Brain+ is to make effective treatments for cognitive decline in Alzheimer’s accessible to everyone as digital therapeutics
More about the Brain+ technologies developed in the ADDP project
TECHNOLOGY: Starry Night cognitive test for early presymptomatic detection of Alzheimer's Disease
Development of the Starry Night technology: The Starry Night test is designed as a game, which builds on the thoroughly researched lab-test developed in Masud Husain’s lab at Oxford University that has shown the ability to distinguish the early cognitive symptoms of Alzheimer’s in multiple studies. The original Oxford lab-test was further co-developed and gamified with Brain+ in the project to enhance engagement, increase specificity, and allow for scalability. The Starry Night test is designed to run on smartphones and tablets so that people can use it from home, thus allowing scalable and remote testing.
Starry Night in trials: Three clinical trials and one Public and Patient Engagement (PPI) study have been carried out in the project to validate the gamified working memory task - Starry Night. The first study was done by Oxford University and sought to replicate the original lab test results in healthy elderlies. This study met with positive results in February 2022 (link). One additional study with individuals with Mild Cognitive Impairment (MCI) was planned at the University of Oxford but it was deemed to be not feasible due to Covid-related restrictions throughout the project. Instead, valuable demographic data was collected. At the University of Nottingham, two studies were carried out. The first was a clinical study involving 86 people with Subjective Cognitive Impairments, here the Starry Night test was successfully used for measuring working memory. The second was a qualitative study in the form of Public and Patient Engagement (PPI), which was conducted to inform the opinion of those living with dementia on Computerised Cognitive Training and cognitive screening tools for early detection. This piece of work has been published (https://games.jmir.org/2022/2/e32489/). Finally, one more study run by Aarhus University with people at genetic risk of developing Alzheimer’s disease is in the final phases with results imminent and the news is expected this quarter.
Next clinical development step for Starry Night: As part of the natural continuation of this project and collaboration, Brain+ is now planning a large-scale trial to gather normative data on Starry Night. This will provide a population performance baseline, against which to compare individuals at risk of developing Alzheimer’s disease, and how outcomes develop over time for more effective future disease detection and treatment.
The Starry Night product use case: Brain+ intends to integrate the Starry Night test in its planned product for people with Mild Cognitive Impairment (MCI) as a sensitive assessment and monitoring tool for changes in cognition for the users. In the longer term, the cognitive test has the potential to become a so-called ‘digital biomarker’ used in the early detection of Alzheimer’s, likely in combination with other biomarkers such as blood samples.
TECHNOLOGY: Computerized Cognitive Training (1st generation) for reduction of mental workload
Development of the CCT technology: A second work stream in the project aimed to reduce the likelihood of developing Alzheimer’s disease in healthy elderlies, who are at risk of Alzheimer’s disease via Computerized Cognitive Training (CCT). This technology was developed based on original work done by Brain+ aiming to alleviate cognitive issues in people with traumatic brain injury. In this project, Brain+ further developed its CCT technology prototypes into the 1st Generation of Brain+ Computerized Cognitive Training (CCT) games.
CCT in trials: The computerized cognitive training was tested in the empirical study done by the University of Nottingham involving the 86 people with Subjective Cognitive Impairments also mentioned above for Starry Night. Results from the study were announced on January 11th (link). Participants demonstrated reduced cognitive load on a demanding working task (Starry Night) after the use of Brain+' Computerized Cognitive Training (CCT) games. Some far-transfer effects of the CCT training were also seen in the participant's performance in a shopping task.
Next clinical development for CCT: The learnings from the 1st Generation CCT games in this project form the basis of the 2nd Generation CCT games that very specifically target the cognitive domains relevant to Alzheimer’s Disease. The 2nd Generation CCT games utilize behavioral interventions that have proven effective in people with Alzheimer’s, both in the stages of dementia and Mild Cognitive Impairment. The 2nd Generation CCT games are being developed and tested in the ongoing €1.5 million ‘ACTTDCS’ innovation project led by Brain and funded by the Eurostars scheme and the Innovation Fund Denmark.
The CCT product use case: The 2nd Generation CCT games will be a central ingredient in the Brain+ product planned for MCI. The MCI targeting product is the third in Brain+’s pipeline, planned to combine CCT and the Starry Night cognitive test as an integrated monitoring tool with Cognitive Stimulation Therapy (CST) technology.
