The MRI data from the Phase 2 study revealed that the proprietary gamma sensory stimulation therapy minimised the decline in white matter/grey matter contrast in the entorhinal region
The non-invasive neuromodulation device. (Credit: Business Wire/ Cognito Therapeutics)
Neurotechnology company Cognito Therapeutics announced that its non-invasive gamma stimulation therapy has lowered brain atrophy and myelin loss in Alzheimer’s disease (AD) in the Phase 2 OVERTURE study.
In the study, the at-home wearable device provided non-invasive gamma stimulation therapy for six months and showed lobe-specific changes in white matter volume and myelination in AD.
According to the MRI data from the Phase 2 study, the proprietary gamma sensory stimulation therapy minimised the decline in white matter/grey matter (WM/GM) contrast in the entorhinal region.
The imaging data also revealed that WM atrophy and demyelination were statistically significantly reduced in all lobes of the left hemisphere.
It also trended towards a decrease in the right hemisphere, in patients on Cognito therapy against sham therapy, showing that 40Hz sensory stimulation may lower the neurodegeneration related to AD.
Additionally, quantitative MRI analysis demonstrated a significantly reduced whole brain, white matter, and occipital lobe volume loss. It also showed a significant reduction in occipital cortical thickness in the active arm relative to the sham group.
Cognito Therapeutics said that these clinical benefits were achieved independent of a reduction in amyloid plaque loads.
Patients in the Cognito therapy group showed a 0.06±0.99% drop in WM/GM contrast after 6 months of treatment, whereas the placebo group showed a 1.26±1.04% decline.
Cognito Therapeutics CEO Brent Vaughan said: “Our Phase 2 OVERTURE study results continue to demonstrate that daily, proprietary gamma sensory stimulation is safe and well tolerated.
“Patients in the active arm demonstrated a reduction in decline in functional and cognitive abilities and showed reduced brain atrophy.
“Our upcoming pivotal HOPE clinical trial will further evaluate the clinical efficacy of our treatment, and also evaluate relevant downstream mechanisms in AD patients.”
In the trial, 135 patients were screened, of which 74 were randomly assigned and 53 completed the study. The therapy was found safe with few negative effects when used daily.
Furthermore, changes in ADCS-ADL and MMSE scores were statistically significant between the sham and therapy groups, showing a much slower rate of loss in both functional and cognitive abilities in the treatment group.