Scientists all over the world are working on drugs to inhibit or treat degenerative diseases of the brain. According to WHO data, 55 million people worldwide suffer from Alzheimer’s, with 10 million new cases detected yearly. However, the new chemical molecules are not the only possible treatment since so-called digital therapeutics (DTx) have begun to enter medicine.
At the Clinical Trials on Alzheimer’s Disease conference in San Francisco, the company announced the start of a clinical trial of the device. About 500 participants will wear the headset for one hour a day. Cognito device is non-invasive and looks like a pair of sunglasses.
Light and sound stimulate selected areas of the brain
The innovation works on the principle of neuromodulation. Its pulsing lights and sounds are aimed at stimulating immune cells called microglia in an effort to clear out proteins that can lead to disease and dementia, according to Cognito. The headset transmits light and sounds at a frequency of 40 times per second. In practice, the patient sees flashes of light and hears the ringing or buzzing. This frequency – according to previous Cognito studies, including one published in the journal Neurology – provides cognitive improvements to people with Alzheimer’s disease.
The Cambridge-based (US) company also presented optimistic findings on the effect of its device on the deterioration of the brain’s so-called white matter – the interwoven connections of neurons that link all four lobes of the brain. Abnormalities in the white matter and its surrounding insulating layer, called myelin, have been linked to Alzheimer’s disease.
“Cognito uses sensory stimulation to evoke gamma oscillations in the brain that have been shown to improve synaptic connections between neurons, activate microglia, and enhance removal of pathological proteins from the brain. This leads to reduced neurodegeneration and brain atrophy, as well as improved sleep, cognitive and functional abilities,” claims the startup.
Still a long way to a breakthrough
Alzheimer’s disease is intractable. Every year, 10 million patients are diagnosed. Although promising new research results are being systematically reported, there has been no breakthrough in treating or preventing the disease. Much excitement has recently been generated by the drug lecanemab from Eisai and Biogen. Clinical trials indicate that it reduces brain plaques associated with Alzheimer’s disease. The medicine could be approved by the US Food and Drug Administration in early 2023.
Cognito’s earlier tests and studies have been so promising that the FDA has granted the company’s solution ‘breakthrough’ status. And that opens the door to an accelerated evaluation process. However, even if Cognito’s headset proves successful in a clinical trial, its commercial launch won’t be possible until 2024. Recruiting participants for the study will take several months, collecting data and submitting it for evaluation is another 12 months.
The device also has downsides that could stand in the way of its widespread use. For example, some patients may find it difficult to wear the headset for an hour a day. And in earlier trials, some patients complained that they experienced ringing or buzzing in their ears.