Results from a clinical study provide promising feasibility indications

for Brain+’ CCT technology for cognitive training

• The results of an 8-week placebo-controlled intervention study in people with Subjective Cognitive Impairments (SCI) demonstrated improved cognitive load 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.

• The indications of clinical feasibility of the CCT technology and the Starry Night cognitive test, provide early support for the Company’s pipeline product for Mild Cognitive Impairment, which combines CCT, Starry Night, and Cognitive Stimulation Therapy (CST).

A study conducted by Nottingham University as part of the Brain+ led European Horizon2020 project called Alzheimer’s Detect & Prevent has provided promising feasibility indications that Computerized Cognitive Training (CCT) can positively impact the cognitive load in people with Subjective Cognitive Impairments (SCI). In addition to the effect on cognitive load, the CCT training also resulted in improvements in the study participants’ performance in a shopping task that mimics real-life shopping.

People with SCI have an increased risk of developing dementia and are therefore a highly relevant segment for Brain+.

We are excited to see a positive impact in the form of a reduction in mental workload after the 8-week training with CCT and also some transfer to improved performance in a real-life task, like shopping, simulated in virtual reality. A question remains as to whether such effects can be maintained in the long term and what level of follow-up training this would take.

Max L. Wilson, Associate Professor in Human-Computer Interaction, Mixed Reality Lab, University of Nottingham, UK, commented on the results

Study design

86 participants with SCI were recruited and followed through an 8-week intervention with Brain+ 1st generation CCT games. The participants were assigned to either the experimental group (trained with adaptive game versions) or the placebo control group (trained with non-adaptive game versions). The training took place 5 days a week, 20 minutes a day for 8 weeks.

All the participants underwent 1) standard cognitive assessments on attention and working memory, 2) brain imaging during a demanding working memory task, which was the Starry Night cognitive test developed by Brain+ and the University of Oxford, and 3) an ecologically valid augmented reality task in a 3D environment at 3 time points, i.e. pre-training, immediately post-training, and at 1-month follow-up. The brain imaging device used was an “Artinis Brite”, a functional near-infrared spectroscopy headset (fNIRS), which can be likened to a portable fMRI, measuring blood oxygenation changes in areas of the brain.

Two Brain+ technologies, CCT and the Starry Night cognitive test, were evaluated in the study

The study evaluated 1) the Brain+ CCT games, which provided the cognitive training element of the intervention, and 2) the Starry Night memory test, which was used to test working memory while participants underwent brain imaging. 

The 1st Generation CCT games and the Starry Night cognitive test have been developed as part of an EU-Horizon2020 funded innovation project led by Brain+ and with partners University of Oxford, Nottingham University, Aarhus University, Aarhus University Hospital, Alzheimer Europe and the European Brain Council. The project has a budget of €3.5 million and began in November 2018. The main objective is to detect and engage people with cognitive impairment early before Alzheimer’s disease manifests to enable prevention efforts. 

CCT and Starry Night are key components in a pipeline product for people with Mild Cognitive Impairment

The indications of clinical feasibility of the CCT technology are important as the 2nd Generation of CCT games will be a central component in a product Brain+ has in pre-clinical development for people with Mild Cognitive Impairment (MCI). MCI is a pre-stage to dementia and a clinical diagnosis, which is affecting an estimated 150-200 million people worldwide. 

The MCI targeting product is the third in Brain+’s pipeline, envisioned to combine CCT and the Starry Night cognitive test as an integrated monitoring tool with the Cognitive Stimulation Therapy (CST) technology. 

The CST technology is the most advanced of Brain+’s platforms as it is the foundation for the CST-Therapist Companion and the CST-Therapist Home Care products. A Danish version of CST-Therapist Companion was introduced commercially in Q4 2022, while German and UK versions are expected to be ready for commercialization later in 2023. 

About Computerized Cognitive Training (CCT)

Brain+ began the initial medical exploration of Computerized Cognitive Training (CCT) aiming at cognitive rehabilitation of brain injury patients, based on existing literature and approaches, which largely used training paradigms based on cognitive tests that were then adapted and gamified for training purposes. The 1st Generation CCT is based on this approach with certain adaptations. With a focused mission to address dementia and Alzheimer’s disease and with recent insights on cognitive training, the 2nd generation cognitive training now targets very specific cognitive domains relevant to the disease area and the utilization of behavioral interventions that have already proven effective based on clinical studies in dementia and Mild Cognitive Impairment specifically. The 2nd generation Brain+ CCT is being developed and validated in the currently ongoing €1.5 million ‘ACTTDCS’ innovation project, funded by Eurostars and the Danish Innovation Fund and led by Brain+. The 2nd Generation CCT design uses the insights gained from the 1st Generation CCT used in this study.

About Starry Night

The Starry Night functional prototype was completed in 2021, and the first study of this technology was done by the University of Oxford which sought to replicate the original lab test results in healthy elderlies. This study met positive results in February 2022 (link). This study on people with SCI has provided valuable data on the test correlating working memory performance with brain imaging data. More results are expected soon from an additional imaging study at Aarhus University involving individuals at genetic risk of Alzheimer’s Disease. 

The mission of Brain+ is to make effective treatments for cognitive decline in Alzheimer’s accessible to everyone as digital therapeutics.