Trial Shows Electronic Treatments Slow Brain Decline

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9 Mar. 2021. Results from a clinical trial show treatments of electronic audio and visual impulses slow cognitive and functional decline in people with early Alzheimer’s disease. Findings from the trial were released by developer of the therapy Cognito Therapeutics in Cambridge, Massachusetts, and are not peer reviewed.

Alzheimer’s disease is a progressive neurodegenerative condition, the most common form of dementia affecting growing numbers of older people worldwide. People with Alzheimer’s disease often have deposits of abnormal substances in spaces between brain cells, known as amyloid-beta proteins, as well as misfolded tangles of proteins inside brain cells known as tau. World Alzheimer Reports says an estimated 50 million people worldwide are living with dementia, a number expected to grow to 152 million by 2050.

Cognito Therapeutics is developing a treatment for Alzheimer’s disease with a technique called gamma frequency neuromodulation. Gamma oscillations are believed to help the brain perform normal functions, including perception and memory. Research by MIT neuroscientist Li-Huei Tsai and bioengineering professor Edward Boyden shows in lab mice, pulsating light waves at the precise frequency of 40 Hz can stimulate gamma oscillations to reduce amyloid-beta plaque deposits associated with Alzheimer’s disease on brain cells. Science & Enterprise reported on this study in December 2016.

Tsai and Boyden are the scientific founders of Cognito Therapeutics. The company’s technology adapts their research using both visual and audio impulses calibrated to an individual’s unique brain wave patterns, as determined by an electroencephalogram or EEG. A study in the journal Cell published in March 2019 by Tsai, Boyden, and colleagues shows in lab mice visual and audio stimulation of gamma oscillations resulted in microglial cells clustering around amyloid-beta plaque deposits, and reductions in those deposits. Microglial cells help protect neurons or nerve cells in the brain.

Two standard tests of cognitive function

The clinical trial is testing the safety and efficacy of gamma frequency neuromodulation among 53 patients at six sites in the U.S., age 55 and older, with early Alzheimer’s disease or mild cognitive impairment. Participants were randomly assigned on a two-to-one ratio to receive audio-visual gamma frequency neuromodulation therapy or a sham treatment for 60 minutes a day for six months.

All participants were assessed with the standard Alzheimer’s Disease Cooperative Study – Activities of Daily Living or ADCS-ADL scale and the Mini-Mental State Examination at the beginning and every four weeks of the trial. Some 30 participants receiving gamma frequency neuromodulation completed the trial, along with 20 participants receiving the sham treatments. Cognito says the gamma frequency neuromodulation treatments were safe and well tolerated, but no other safety data, such as lists of adverse effects, were released.

Results from the ADCS-ADL scale show participants receiving gamma frequency neuromodulation declined at an 84 percent slower pace than participants receiving the sham treatments. Likewise, declines on the Mini-Mental State Examination scores were 83 percent less for gamma frequency neuromodulation recipients than the sham treatment group. In addition, MRI scans show less whole brain atrophy and volume loss after six months among gamma frequency neuromodulation than sham treatment recipients. (The company released only percentage changes, not raw scores.)

“Our approach has translated into clinical proof of concept,” says Cognito Therapeutics chief medical officer Tom Megerian in a company statement released through BusinessWire, “by successfully achieving statistically significant results in AD, with a potential for disease modification due to significant reduction of cerebral atrophy and volumetric loss.” Megerian adds, “If these results are replicated in our larger, pivotal trial, this will represent a huge medical breakthrough in Alzheimer’s research.”

More from Science & Enterprise:

• Immune Response Shown in Alzheimer’s Vaccine
• Start-Up Creating Digital Therapies for Alzheimer’s
• Trial Shows Radio Waves Safe for Alzheimer’s Therapy
• Trial Testing MRI, Ultrasound as Alzheimer’s Therapy
• Lilly, Biopharm Partner on Alzheimer’s Treatment in $2B Deal

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