| Abstrakt: |
Background: Developing safe and disease modifying therapies for Alzheimer's disease (AD) is still challenging, in spite of recent advancements in the understanding of AD pathophysiology. A fundamentally different therapeutic approach under development at Cognito Therapeutics targets abnormal neuronal activities using the company's Gamma Sensory Stimulation System. This treatment is based on the recent breakthrough, demonstrating that 40Hz neuronal network oscillation evoked via optogenetic, or sensory stimulation profoundly reduces AD pathologies in AD‐related transgenic mice. Method: This presentation will provide an overview of the main findings from a clinical trial (NCT03556280) which evaluated Cognito Therapeutics Gamma Sensory Stimulation System as a potential novel therapeutic intervention for AD, evaluating feasibility, safety, tolerability, and efficacy of this treatment. In the 6‐month long, double‐blinded, randomized, controlled, clinical trial, participants with clinical presentation on the AD spectrum, were randomized 2:1 (active:sham) to receive daily, one‐hour 40Hz audio‐visual stimulation treatment using Cognito's Gamma Sensory Stimulation System or sham stimulation. Result: A total of 135 subjects were screened, of whom 74 were randomized and 53 completed (20 sham arm, 33 active arm). Daily use of the Gamma Sensory Stimulation System was confirmed to be safe with minimal side effects. MRI data confirmed the absence of ARIA in participants. High adherence to daily therapy was established based on device‐recorded usage. In assessing cognitive and functional abilities, changes in ADCS‐ADL and MMSE scores were statistically significant between the sham and treatment arms, demonstrating a significant slowing in functional and cognitive decline in the treatment group. Further, quantitative MRI analysis revealed a significantly reduced whole brain, white matter, and occipital lobe volume loss, along with a significantly attenuated reduction in occipital cortical thickness in the active arm relative to sham. These clinical benefits were achieved independent of a reduction in amyloid plaque loads. Conclusion: Our results demonstrate that daily 40Hz sensory stimulation delivered by Cognito's Gamma Sensory Stimulation System is safe and well tolerated; patients in the active arm maintained their functional and cognitive abilities, showed reduced brain atrophy. The upcoming pivotal clinical trial will further evaluate the clinical efficacy of this treatment, also evaluating its most relevant downstream mechanisms in AD patients. [ABSTRACT FROM AUTHOR] |
