Non-invasive neurostimulation given to people with mild-to-moderate Alzheimer’s disease significantly and safely slowed their rate of functional and cognitive decline, meeting key goals of the Phase 2 OVERTURE study, according to data presented at the 2021 AD/PD Conference.
Its neurostimulation device, being referred to as a digital therapeutic, uses gamma frequency technology for neuromodulation. With this system, a patient’s brainwave patterns are analyzed to design an individualized sequence of visual or auditory signals meant to provoke certain therapeutic neural activity.
“We’re excited to announce our Phase 2 data, which demonstrated significant improvements in memory, cognition and reductions in brain atrophy and volumetric loss in [Alzheimer’s] patients who received treatment with gamma frequency neuromodulation compared to placebo,” Brent Vaughan, CEO of Cognito Therapeutics, the device’s maker, said in a press release.
The study (NCT03556280) involved 76 adults, ages 50 and older, with mild-to-moderate Alzheimer’s and other forms of cognitive impairment or dementia.
Patients were randomized to either 40 hertz (Hz) of gamma frequency neuromodulation or a sham stimulation (placebo), given at the home for one hour each day for six months.
Changes in functional abilities from baseline — the start of the study — using the Alzheimer’s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) scale, and changes in cognitive decline via the Mini-Mental State Examination (MMSE) were evaluated for participants with this disease.
Brain atrophy and changes in brain volume were also measured using magnetic resonance imaging, taken once at the study’s start and again after six months of treatment.
Cognito reports that 33 Alzheimer’s patients given gamma frequency neuromodulation showed an 84% slowing of functional decline and an 83% slowing in memory and cognitive decline relative to 20 patients on sham stimulation. Thirty treated patients also demonstrated a 61% reduction in brain atrophy and volume loss compared to 19 people in the sham group.
The company interpreted the decline in atrophy and volume loss as evidence of a potential disease-modifying effect, meaning that the treatment may act on Alzheimer’s underlying disease mechanisms.
“In addition to improving functional outcomes, memory and cognition, the 61% reduction in loss of whole brain volume in our Phase 2 study addresses key aspects of [Alzheimer’s] etiology and disease progression,” said Tom Megerian, Cognito’s chief medical officer.
“If these results are replicated in our larger, pivotal trial, this will represent a huge medical breakthrough in Alzheimer’s research,” he added.
According to the company’s website, a pivotal trial is planned to launch this year. More information was not available.
The treatment was also reported to be safe and well-tolerated.
“The combined clinical and biomarker findings suggest beneficial effects of gamma frequency neuromodulation in [Alzheimer’s], which may be facilitated via differentiated pathways compared to traditional pharmacologic approaches,” said Zach Malchano, president of Cognito Therapeutics.
The technology received breakthrough device designation from the U.S. Food and Drug Administration (FDA) in January. This designation allows for priority review of an approval application for this treatment approach, and expands company access to the FDA regarding device development, clinical trial protocols, and commercialization decisions.
“With our recent FDA Breakthrough Device Designation,” said Vaughan, “we look forward to expediting the clinical development of what has the promise to be the first disease-modifying digital therapeutic in Alzheimer’s disease.”
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