BrainsWay this week announced results from a pilot study of its Deep TMS device in a population that gets left out of most depression research: patients who have both major depression and early-stage Alzheimer’s disease at the same time. The study is peer-reviewed, published in the Journal of Geriatric Psychiatry and Neurology and online since 2025; what’s new is the company’s September 8 announcement promoting it. Twelve patients received 36 sessions of magnetic brain stimulation. Afterward, 83.3 percent showed a meaningful drop in depression symptoms, and half reached full remission. Those numbers sound strong. They come from a study with nothing to compare them against.
A population most trials leave out
An estimated 30 to 50 percent of people with Alzheimer’s disease also have major depression, according to the study’s own background research, and this overlap is an underserved gap: standard depression trials typically exclude people with cognitive impairment, and standard Alzheimer’s research usually isn’t built to treat mood symptoms directly. That gap makes this a worthwhile population to study, independent of whatever this specific pilot ultimately shows. The treatment protocol itself is specific to that dual diagnosis: one coil targeting the brain region typically used for standard depression treatment, then a second coil, the one BrainsWay normally uses for its OCD-cleared treatment, stimulating temporal regions on both sides linked to Alzheimer’s pathology.
What the brain scans showed
Researchers measured brain activity before and after treatment using quantitative EEG, a technique that reads electrical patterns across the scalp. Two changes stood out. Delta-wave activity dropped in the right temporal lobe, a pattern some researchers associate with reduced “cortical slowing,” a marker linked to Alzheimer’s progression. And alpha coherence, a measure of how well different brain regions synchronize with each other, increased between several frontal and temporal areas, potentially reflecting improved connectivity, another feature often disrupted in Alzheimer’s. These are specific, measurable changes in brain activity. They’re a different kind of evidence than a patient’s self-reported mood score, and worth taking seriously as a signal that something in the brain shifted during treatment.
Why the topline numbers still need a caveat, not a headline
Nothing about this design lets a reader rule out simpler explanations for the response and remission rates. There was no placebo or sham-treatment group, no comparison arm of any kind. Every patient in the study knew they were receiving active treatment, delivered across 36 real sessions, by a real device, in a real clinical setting, exactly the kind of sustained, attentive care that reliably produces some improvement in mood symptoms on its own, independent of whether the specific mechanism being tested does anything at all. Depression symptoms also naturally fluctuate over time, and a study with no comparison group can’t separate improvement caused by treatment from improvement that would have happened anyway. None of this means the treatment doesn’t work. It means a single-arm study with twelve patients cannot tell you whether it does.
What would settle the question
The company’s own release states plainly that Deep TMS isn’t FDA-cleared for Alzheimer’s and that controlled research is still needed, an honest acknowledgment worth noting directly instead of glossing over. A proper test of this specific claim would need a sham-controlled comparison arm, a larger sample than twelve people, and ideally the same QEEG measurements taken in both the treated and sham-treated groups, to see whether the brain-activity changes track specifically with active treatment or show up regardless of which group a patient was in. Until a study like that exists, the QEEG findings are the more durable part of this result. The response and remission percentages are not.
A device company with approvals already in hand, testing a new population
BrainsWay already holds three FDA-cleared indications for Deep TMS, giving it an established commercial and regulatory track record in this device category, unlike many of the earlier-stage pharmaceutical candidates covered on this beat. A device company with existing approvals extending its technology into a new, underserved population is a meaningful strategic move even before the evidence is conclusive, and the specific biomarker approach here, using objective brain measurements rather than relying entirely on symptom scales in a population where cognitive impairment can complicate self-report, is a methodologically sound direction regardless of how this particular pilot’s topline numbers hold up under better-controlled follow-up.