Revolutionising Alzheimer’s Treatment: Alz Care Device Clinical Trial Commences

This month brings the start of our ground-breaking clinical trial, investigating the clinical potential for their innovative device in treating Alzheimer’s Disease. A growing and promising area of research, the Alz Care clinical trial marks a significant step forward in the quest for safe and effective Alzheimer’s treatment options.

Dementia currently impacts over 900,000 individuals in the UK and 55 million people globally. These numbers are projected to double every 20 years, potentially affecting 139 million by 2050. In the UK, dementia stands as the leading cause of death among women and the second among men, with Alzheimer's Disease (AD) being the most prevalent form, affecting 50-70% of dementia patients. Established medications merely alleviate symptoms. Emerging disease-modifying drugs have no proven benefit for many subsets of patients, and have substantial safety risks including brain swelling, brain bleeding, and deaths reported during clinical trials and are not approved for use in the UK and Europe. Given the absence of a cure and safe pharmaceutical options, the urgency for innovative Alzheimer’s treatments has never been greater.

The phase 2, multi-centre, randomised, sham-controlled trial (ALZ-Care-01) aims to assess the safety, tolerability, and clinical efficacy of the innovative AlzCare™ device in patients with Mild to Moderate Alzheimer’s Disease. Designed for at-home use, this device presents a promising new approach to managing this debilitating condition. The Alz Care patented technology employs photobiomodulation (PBM) therapy, which involves the controlled delivery of near-infrared light to the prefrontal cortex region of the brain via a wearable headset. The study seeks to validate the hypothesis that PBM can effectively slow the progression of AD. Early research indicates promising potential for PBM to target the primary causes of AD through multiple pathways.

AD is a complex brain disorder caused by several key issues. The accumulation of amyloid-beta proteins forms plaques between neurons, disrupting cell function. Inside the cells, twisted strands of another protein, tau, create tangles leading to cell dysfunction and death. Chronic inflammation in the brain, which occurs as part of the body's immune response to the accumulation of abnormal proteins and the resulting damage to neurons, further harms the cells and contributes to disease progression. The combined effects of plaques, tangles, and inflammation result in widespread neuron death, causing the brain to shrink, especially in areas important for memory and thinking. As a result, people with Alzheimer's experience memory loss, poor judgment, and difficulty thinking clearly. All these factors together lead to the progressive decline seen in Alzheimer's Disease. Together, these factors contribute to the progressive deterioration seen in Alzheimer's Disease, severely impacting memory and cognitive abilities.

It is believed the near infrared light delivery of PBM treatment enhances cellular energy production in neurons by stimulating ATP synthesis. This boost in energy can potentially improve neuronal function and resilience against damage, which is crucial in neurodegenerative conditions like Alzheimer's. Moreover, photobiomodulation may help to reduce inflammation in the brain, by modulating the immune response, leading to decreased neuroinflammation. Furthermore, studies indicate that photobiomodulation may play a role in preventing the build-up of amyloid-beta proteins and plaque. It is also suggested to facilitate the clearance of existing amyloid plaques by enhancing cellular mechanisms involved in protein degradation.

We have partnered with Re:Cognition Health, a globally recognised leader and award-winning provider specialising in cognitive health. They are renowned for their expertise in diagnosing, treating, and caring for individuals with Alzheimer’s Disease, dementia, cognitive impairment, and mental health issues. With over 100 trials conducted across their six clinical trial sites in the UK, Re:Cognition Health brings extensive experience in managing clinical trials. They will oversee all aspects of the 18-month clinical trial, from patient recruitment to monitoring, assessment, and reporting.

Neil Wright, CEO of AlzCare Ltd., expressed enthusiasm about the collaboration: "We are thrilled to work with Re:Cognition Health, experts in clinical trials focusing on cognitive function and neurodegenerative diseases, to launch this pivotal clinical trial. Alzheimer's Disease presents significant challenges for patients and families alike. Our objective is to offer a safe, accessible, and effective treatment option that can truly improve the lives of those affected."

The clinical trial will span 24 months and take place at three Re:Cognition Health sites located in Guildford, Bristol, and Birmingham. Participants will be required to use the treatment device for 30 minutes daily, six days a week, over an 18-month period. Patient recruitment is currently in progress.

AlzCare Ltd. is committed to exploring and advancing the therapeutic potential of photobiomodulation and Alzheimer’s research and bringing innovative solutions to market. Alz Care Ltd. is a subsidiary of TensCare Ltd., an employee-owned business that provides at-home medical devices including electrotherapy pain relief and muscle rehabilitation.