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), kim@brain-plus.com

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