First patient enrolled in a clinical trial to evaluate Brain+’ next generation cognitive training technology for Mild Cognitive Impairment

Copenhagen, Denmark, 5 September 2024 – Brain+ A/S (Nasdaq First North: BRAINP)

In collaboration with Aalborg University Hospital, Brain+ has started a clinical trial of its next generation cognitive training technology, BrainBlossom. BrainBlossom is designed to offer specific cognitive training for people with Mild Cognitive Impairment (MCI), often a pre-stage for a dementia diagnosis. The BrainBlossom game has been developed with top scientists as part of a €1.5 million EU grant funded partner project and is a core element in Brain+’ pipeline product, CST-MCI. After this new training software has been tested in healthy adults, the clinical trial in 40 people with MCI shall now test its feasibility and impact as a home delivered treatment. If the trial is successful, next steps are a larger clinical trial to generate regulatory data and a partnership, likely with a pharmaceutical company, for commercialization. MCI represents a very large market with an estimated 150-200 million people worldwide living with MCI (3-4 times as many as with dementia), and many new dementia drugs also target MCI (e.g Lecanemab/Lequembi).

• The Brainblossom technology builds on a validated cognitive training method for MCI and can enable therapeutic delivery at scale and at home
• A two-armed randomized controlled clinical trial has now started to test the effect and feasibility of BrainBlossom in 40 people with MCI
• Trial results are expected to be available in early 2025 and if positive lead to a larger clinical trial to generate regulatory data, and a partnership
• Study protocol has been published as a preprint in psyArXiv

Brain+ A/S (“Brain+” or “the Company”) informs that a clinical pilot trial has started to test its next generation cognitive training software, called the Brain+ Brainblossom Game (“BrainBlossom”), in people with Mild Cognitive Impairment (MCI). The trial will be conducted Aalborg University hospital, Denmark under the supervision of Neurologist, Professor Jakob Blicher.

Nahid Zokaie, Chief Scientific Officer, commented on the start of the trial:

“I am thrilled to begin the randomized clinical trial with MCI patients. Our proprietary Brainblossom cognitive training technology builds on an already proven methodology for cognitive training in MCI and dementia. With our solution, this impactful method now has the potential to be delivered at scale and directly into the homes of people to the benefit of many more living with MCI.”

Brainblossom has been developed under the Company’s €1.5 million Eurostars grant funded ActNow project and is a core element in the CST-MCI product in the pipeline. The cognitive training technology is tailored for people with MCI and has been developed based on a validated framework method, which was recently published in Neuroscience & Biobehavioural Reviews within the consortium of partners. Read the framework article here:  https://www.sciencedirect.com/science/article/pii/S0149763424003075.

The trial is set as a randomised, single-blind controlled study, planned to enroll up to 40 people with MCI. The study has two arms, one with an active condition and one control arm, and study participants will randomly be assigned to one of the two arms, going through a 4-week at home training program. The active condition arm will train memory based on the BrainBlossom solution, while the control arm will look identical, however not include the training element. Patients will be blind to their assigned condition to minimize the impact of expected training effect and patient outcomes. Prior to and after the 4-weeks of training, study participants will go through a comprehensive battery of cognitive tests and questionnaires to identify the extent of the effect of training on their level of cognition.

The study will investigate the feasibility of using the BrainBlossom solution as home-based cognitive training for people with MCI and critically explore the impact of the training on commonly experienced cognitive impairments in MCI, namely impairments in short and long-term memories.

The study protocol has been published in psyArXiv and can be found https://osf.io/preprints/psyarxiv/dhwg3.

The study is expected to run through the rest of 2024 and results to be available in early 2025.

MCI is a segment of future interest for Brain+. An estimated 150-200 million people worldwide are living with MCI (3-4 times as many as with dementia), and the condition represents a large unmet clinical need and market opportunity. MCI is a natural part of the Brain+ mission of improving dementia management, addressing the disease earlier in its progression, where the impact of cognitive training has shown to be biggest.

If the ongoing clinical trial is successful, next steps for Brain+ with the BrainBlossom training technology will be a larger trial for regulatory data generation, and to enter into a partnership for market-access and commercialization. Such partner could likely be a pharmaceutical company, whose Alzheimer’s drug pipeline also targets the MCI stages (eg. Lecanemab/Lequembi), and to which CST is complementary. The Brain+ pipeline product, CST-MCI, will target MCI as a combination of Cognitive Stimulation Therapy (CST) and the Brainblossom cognitive training technology for a powerful multi-modal approach to treating cognitive decline in MCI.

Contact Information

CEO and Co-founder: Kim Baden-Kristensen, + 45 31 39 33 17 (SMS), [email protected]

Brain+ mission: Become the preferred provider of certified health tech solutions for better dementia management, servicing one million people affected by dementia in 2030.