Granny, the Past and the Future

AFAIK Dispatch #7

Alzheimer’s Families for Action, Innovation and Knowledge

My mother-in-law, Frances Bigda, passed away recently, from complications of Alzheimer’s Disease and the flu. She was very intelligent, cultivated an active physical and intellectual life, and had a life-long teaching career culminating in becoming a high-school principal. She was also beloved “Granny Franny” to her grandchildren. We miss her.

I wrote the following .

My Mom died of complications from Alzheimer’s Disease (AD) after about a 15 year battle. My mother-in-law has suffered AD-related decline for at least 5 years, and went into memory care this past year. What has struck me most about their situations is that there is essentially no change in guidance of how to live with AD, no better advice in how to approach being a caregiver, and especially that there has been no advance in 20 years in how to treat the disease, either to slow the decline or reverse the effects.

That was the first of my AFAIK series, and so far, we have seen regression rather than progress. 20 years… But I’m not giving up. Below are some interesting tech developments, followed by a few sardonic notes about the drags on progress due to bureaucracy and skewed financial priorities.

Technology Developments

I note that technology progress continues despite the problematic structural, political and regulatory environment that is a drag on the development of treatment solutions. I attended the iconic Consumer Electronics Show a couple weeks ago and note at least one hopeful trend, coming not from the pharmaceutical giants but from Korean tech companies.

iMediSync –In 2021 the company offered an “iSyncBrain” platform that, with the aid of AI, identified biomarkers for Early Cognitive Decline. The newly announced “iSyncWave” product provides a QEEG guided, personalized light therapy (photobiomodulation, or PBM) protocol with built-in LEDs. “The optimum targeting PBM protocol for Alzheimer’s, strokes, traumatic brain injuries is now in the development stage.” The company claims PBM is effective for this purpose, although clinical research has not been widespread. (And the field is somewhat muddied by lightly regulated Red Light therapy and TENS products.) The iSyncWave device at least has received FDA 510K clearance for safety.

More noteworthy, a of the literature, Photobiomodulation Therapy for Dementia: A Systematic Review of Pre-Clinical and Clinical Studies, concluded “The preliminary evidence of clinical benefit, the lack of any adverse effects, and the remarkable ease of use, suggest larger clinical trials should be conducted as soon as possible.”

The FDA is also acting to provide more support for further research and product development in this area, recently issuing a for PBM 510k submissions.

Other companies in the neuromodulation space that exhibited at CES 2023:

Megnosis (Korea) — Company offers the Brainspect20 headset, combining EEG readouts with deep learning technology for dementia detection, and the Braincure20 headset combining EEG and transcranial Direct Current Stimulation. It was difficult to find on their Web site any safety or efficacy research or certification.

Ybrain (Korea) — Company offers an EEG diagnostic device for medical practitioners and also a neurostimulation device and treatment platform for depression. They have a line of TENS products for pain relief and relaxation.

Abbott — They exhibited a clinical-grade plus digital treatment platform for Parkinson’s disease. I asked a staff researcher on the booth about products for treating cognitive decline, and he said they had nothing at this time, in part because “measuring success is difficult.”

AARP — The organization had a sizeable booth, but as indicated in , their product displays and organizational focus are not about treatment as much as living with aging and its consequences, including cognitive decline.

Medtronic was not in evidence at CES, but I’ve noted that the North American Neuromodulation Society (NANS), supported by Medtronic, Abbott and Boston Scientific, has in the past hosted a booth to communicate to a consumer audience about safety and efficacy of neuromodulation for some indications. They were not present this year as NANS also holds its annual research conference in January — more about that in AFAIK Dispatch #8.

Apart from the CES news, here’s some hopeful tracking news on neurostimulation for treating cognitive decline

Cognito — In recent ,Cognito Therapeutics has launched HOPE, the pivotal study of its wearable GammaSense stimulation device designed to treat cognitive and functional symptoms in patients with mild-to-moderate Alzheimer’s disease. Cognito expects to complete enrollment and have its first data readout by 2025.”

Slow progress, alas, but at least progress. It’s worth noting that while big players like Medtronic and Abbott have received numerous FDA approvals for neurostimulation products for treatment of epilepsy and Parkinson’s, they are beaten to the market (or maybe not even entered in the race) for AD treatment.

COGNISANT — COGNISANT presents an interest combination product of transcranial Direct Current Stimulation and a digital therapeutic for “working memory training concluded, “We found that individual characteristics influenced the outcome of combined cognitive training and tDCS regimens, with the intervention selectively benefiting old-old adults with lower working memory capacity.”

And just to show that not only the big players follow the market, a company I’ve met with, Vielight, offers PBM products under the Vielight Neuro brand. The nose clip has always kind of put me off (first saw this in 2019), and I wonder how receptive elderly patients would be, but the company did around 2016–2109 that showed some success for dementia treatment. But more recent research appears focused on treatment of Parkinson’s, Autism Spectrum Disorder and COVID. Like Abbott perhaps, following the market, or not getting traction on dementia from a business perspective.

Finally, FYI, I came across this , featuring several products I haven’t looked at yet, for those who want to check it out. This link is to AD and dementia products, but the larger directory covers many other categories.

The Department of Bureaucracy and Skewed Financial Priorities

Meanwhile, I see that and have discovered FDA/Pharma Scandal, a year later than and Medicare members paid an extra $300 in premiums. From the Congressional Report:

The report also highlighted that the FDA and Biogen staff “worked closely for several months” ahead of a November 2020 advisory committee meeting — so much so that at least one paragraph of Biogen’s submission was written by FDA officials.

No word on a refund of the extra $30.

The Post editorialized on the Congressional Report:

The Food and Drug Administration’s process for scrutinizing new drugs is unrivaled in the world, and the American people expect it to demand a high standard for safety and efficacy. But a congressional oversight staff released Dec. 29 on the application of Biogen for its Alzheimer’s drug, Aduhelm, highlights by the company and agency. Their cozy dealing undermines public trust.

Nevertheless, there’s still a pharma horse race. Biogen has since abandoned aducanumab but is now riding the pony, with apparently no consequences for their bad (corrupt?) behavior. In fact, they were given . 

Others still in the race, though stumbling, include

- . (Roche and Genentech)

- . (Eli Lilly)

To conclude, I feel things have moved sideways in the past year, and so I look forward to reviewing the reporting from the North American Neuromodulation Society in the next Dispatch.

Happy new year to all.

For past dispatches, see the .



The mission of Neurosphere Technologies (NST) is to further develop digital technology and businesses in the service of mentalhealth, wellbeing, and human potential. The company has a particular focus on improved consumer pricing for Brain-Computer Interface (BCI) technology.

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Don Dulchinos

Experienced senior tech exec. Now leading TransTech Boulder, building tech for mental wellness, emotional wellbeing, and human flourishing.