Cognito Therapeutics, a neurotechnology company advancing disease-modifying therapies to treat CNS diseases, announced robust lobe-specific changes in white matter volume and myelination in Alzheimer’s Disease (AD) patients following six-months of non-invasive gamma stimulation therapy using the at-home wearable device.
The company presented new imaging data at the Alzheimer’s Association International Conference 2023 from the Phase 2 OVERTURE study, that reported its proprietary gamma sensory stimulation therapy reduced the decline in white matter/grey matter (WM/GM) contrast in the entorhinal region. The entorhinal region of the brain is of particular interest in the early stages of AD, and early intervention with Cognito’s therapy may result in enhanced tissue preservation and reduced neurological damage.
“Our Phase 2 study demonstrated that Cognito’s proprietary disease-modifying therapy reduced brain atrophy and myelin loss in Alzheimer’s patients. Our recent results at AAIC 2023 quantifies the effects of our therapy in the entorhinal region of the brain, which indicates that early intervention with Cognito therapy could enhance tissue preservation and reduce neurological damage,” said Ralph Kern, M.D, MHSc., Chief Medical Officer, Cognito Therapeutics.
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Recent studies have reported early changes to oligodendrocytes and transcription of myelin protein genes in the white matter prior to symptoms of cognitive decline, even in subjects with AD but without other neurological comorbidities. Since neuronal activities, particularly network oscillations have been shown to promote axonal myelination, Cognito conducted a post hoc analysis to examine how Cognito’s proprietary non-invasive gamma stimulation affected white matter volume and myelination in different cortical lobes in patients with AD.
Imaging Results from OVERTURE Study
New imaging data reported from the Phase 2 OVERTURE trial showed that white matter atrophy and demyelination were statistically significantly reduced in all lobes of the left hemisphere and trended towards reduction in the right hemisphere, in patients on Cognito therapy versus sham therapy, demonstrating that 40Hz sensory stimulation may reduce the neurodegeneration associated with AD.
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.
SOURCE: Businesswire