Another gadget that might control Alzheimer's disease?

We are not done with new ideas about how to slow or stop Alzheimer's disease, and some of these involve electrical devices.  We wrote once before about the possibility that flashing lights might do something helpful.  And so a new idea has come along -- imposing magnetic pulses on the brain.

The underlying idea for most of these devices is that our brain waves get out of whack in Alzheimer's disease.  Since brain waves are important to the regulation of movement and storage of information in the brain, perhaps forcing the brain waves to behave better might slow or stop the disease.

The brain waves in question are called gamma waves, and they have frequencies of 25 to 135 Hz.  On the piano, middle C has a frequency of 262 Hz, and the electricity in your house has a frequency of 60 Hz.  During quiet wakefulness, some scientists have measured brain waves bouncing around between 30 and 40 Hz.  During deep sleep, the frequency drops to 4 Hz or lower -- these are delta waves.  (For a breakdown of gamma, beta, alpha, theta, and delta brain waves and what we know about them, click here.)  Of course, we discussed the importance of the slow delta waves during deep sleep in Beating the Dementia Monster. 

The concept behind the flashing light strategy was to force brain waves back into whack.  So if flashing lights would work, why not magnetic pulses?  New research published in the journal Frontiers in Neurology proposes just that.  But will it work?  Spoiler alert:  Great idea, but maybe not.

The company Actipulse Neuroscience just completed research testing whether their neurostimulator is safe.  They conducted a trial in which the devices were deployed to test participants in Mexico with training on how to use them.  The participants then used the devices at home twice a day for six months.  There were 34 participants, half of whom used a "sham" device as a control.  Sixteen using the real device actually lasted to the end of the trial with one dropping out.  Proper use of the devices was monitored remotely.  Most participants complied with their instruction.

This was a phase 1 trial, and the first purpose of a phase 1 trial is to find out if the treatment is safe using just a few participants.  Thirty-four participants will tell us whether the treatment will cause people to just drop dead, but its not enough to render reliable data regarding the effectiveness of the treatment.  It's not even enough to tell us whether the treatment causes more subtle adverse health effects.  Recall that the phase 1 trial of aducanumab (now sold as Aduhelm) rendered very positive results for effectiveness, but the phase 2 trial results were very disappointing.  (The phase 3 results were considered good enough to get conditional approval from the FDA, but their validity is in question.)

But what did Actipulse Neuroscience find in the phase 1 trial of their neurostimulator device?  It's safe with a few side effects, but it doesn't seem to help restrain Alzheimer's disease.  Here is their press release.

Since the device didn't help with controlling Alzheimer's disease during the trial, is it game over?  Thirty-four test subjects, half of whom had the sham control device, is not enough to statistically establish anything with respect to efficacy, positive or negative.  So, no.

And there are some questions in my mind.  What would happen if you ran the test longer?  Would you get better results?  What would happen if participants used the device for longer periods each day?  They tried the device in the higher regions of the gamma spectrum -- 60-135 Hz.  What would happen if they tried it in other frequency ranges?

Obviously, Actipulse needs to move ahead with a phase 3 trial with more participants.  Judging by their upbeat assessment of the results, that's just what they will do.