Add Baxter International’s Gammagard to the ash heap of failed Alzheimer’s drug candidates.

Baxter announced today that Gammagard did not provide any cognitive or functional improvement in 390 patients with mild to moderate Alzheimer’s disease. The patients who were enrolled in the Phase III trial received the drug through infusions over an 18 month period.

This outcome isn’t surprising for a number of reasons, including Baxter’s decision to proceed with an expensive Phase III trial based on modest improvement in a total of 4, count them: 4 patients in an earlier trial.

Gammagard is now added to the list of other clinical trial blowups that relied almost exclusively on the amyloid hypothesis. Turning the Alzheimer’s research community towards other avenues such as hyperphosphorylated tau may pick up speed now with amyloid clearance drugs approaching 20 clinical trial fails.

Readers can download a free report on early detection testing for Alzheimer’s disease that also includes a snapshot of other Alzheimer’s drug candidates.
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Want to be able to see and monitor your brainwave activity on your smart phone? There’s an app for that – or there will be by the end of this year, based on demonstrations shown at the Neuro Gaming conference this month in San Francisco.

By using consumer friendly EEG recording sensors, packaged in a wireless headband linked to a smartphone, companies like Toronto based InteraXon are pioneering the development of personal neuro devices that will be used for a wide range of wellness and entertainment applications.

Other neuro device companies include Samsara Labs, developing a transcranial direct stimulation (TDCS) headband, Personal Neuro Devices, a company developing neuro games for smartphones and tablets, and Blue Marble Game Company, developing immersive games for neuro-rehabilitation and repair, after brain injuries such as stroke and severe, debilitating concussions.

We believe this emerging market will develop along two main paths:

1. A lightly regulated market for consumer wellness neuro devices and applications, with companies using the standard disclaimer along the lines of “This product has not been evaluated by the FDA, and is not intended to diagnose, treat, cure, or prevent any disease.”

2. A formally regulated market for medical devices and applications. Some companies will choose this somewhat arduous and expensive route because it establishes a higher level of credibility with the buyers, which in this case will be the health care insurance companies.

The disruptive technology and distribution models being developed by neuro device companies also bring the additional possibility of a parallel, unregulated gray-market, where enterprising free agents combine neuro devices and applications in new ways to provide a cognitive high performance edge to people willing to pay for a perceived competitive advantage (think about the sports performance doping market among pro athletes, and you can see where this could go.)

Welcome to the emerging world of personal neuro devices!

See also: Brain Training: Does it Work?
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If you’ve wondered why men and women can sometimes respond differently to the same emotional event, an integrated neuroscience session hosted by the American Academy of Neurology last month sheds some interesting light on possible causes.

Larry Cahill, Professor of Neurobiology and Behavior at UC Irvine, provided details on recent brain imaging research that indicate different activation levels of the amygdala in men and women, in response to the same emotional content.

The amygdala, commonly known as the “fear center” in the brain, is actually involved in processing a wide range of both negative and positive emotions. We have two amygdalae in our brains – the right amygdala handles the gist, or “big picture” content, while the left amygdala is better at the details of the same emotional content.

Dr. Cahill reviewed data from recent studies that indicate two things: that in men the right amygdala is preferentially activated in response to emotional content, while in women, the left amygdala is activated more by the same emotional content. (In one of the studies, the emotional content included a story about the death of a child, which was obviously designed to elicit feelings of sadness.)

This “gender lateralization” of emotional processing has recently been confirmed through several other brain imaging studies. The results are also a bit counterintuitive, with male brains apparently picking up the ‘big picture’ part of emotional content, while female brains preferentially process more of the ‘who/what/where/when/why’ part of the same emotional story.

These results also have some important implications for central nervous system (CNS) medications like antidepressants and anxiolytics (anti-anxiety drugs). It could be that one medication for both men and women is the wrong approach for any drug that acts on the CNS. (This is something that pharmaceutical companies probably won’t want to hear, since it means increased expense in clinical trials.)

Dr. Cahill’s work on gender differences in the human brain challenges several decades of dogma in neuroscience and related fields that except for hormone and reproductive differences (mainly with the hypothalamus), there are no credible or important differences in how men and women process emotional information. His research efforts strongly suggest the reverse is more accurate.

See also: Brain Health Primer – Four Ways to Maintain Your Brain
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With sophisticated brain imaging tests now making their way out of research labs or clinical trials, and into the doctor’s office, both patients and physicians will have to confront some important ethical and legal questions on how these tests are used. That’s the message from a seminar on amyloid imaging, hosted by the American Academy of Neurology annual conference in San Diego this month.

Most of the brain imaging focus is on detecting the presence of amyloid beta, a type of protein that is the hallmark of Alzheimer’s disease pathology in the brain. Amyloid beta is also present in the brains of persons with Mild Cognitive Impairment (MCI), a milder disease state that may lead to full blown Alzheimer’s later on. Surprisingly, a significant percentage of cognitively healthy older adults also have amyloid deposits in their brains. There is still debate on whether amyloid presence in the brains of cognitively healthy adults has any predictive value on the chances of developing Alzheimer’s disease later in life.

(Download a copy of the state of the market report on early detection tests for Alzheimer’s disease.)

This situation brings up a series of interesting questions:

Can life insurance and long term care insurance providers demand an amyloid imaging test, and potentially deny coverage based on those test results, even for people that are cognitively normal?

Can a person with MCI, and a positive amyloid imaging result, still drive a car? (Yes, most likely they can.) Should they still drive a car? (Some US states mandate physician reporting of “impaired drivers” to the DMV.)

Are most physicians prepared to educate patients on the results and implications of amyloid imaging tests? (Probably not.)

This last question gets to the heart of one looming ethical issue with brain imaging tests: A model for physician and patient education on what an amyloid imaging test result means doesn’t exist yet. This opens the door to much potential confusion and patient harm if the test results aren’t understood in a framework that physicians and patient advocacy groups agree on.

MyBrainTest will continue keep an eye on this issue as it percolates in the health care industry.
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Imagine stepping into a virtual reality environment that recreates in amazing detail the sights, sounds, and smells of a past experience, or a setting that triggers addictive behaviors, such as a bar scene with a favorite drink placed in front of a recovering alcoholic. And then into this virtual reality steps a helpful digital avatar that guides the user through difficult emotions, and into developing better coping skills.

That’s the goal of new cognitive technology systems in development that were demonstrated at the ESCoNS 2.0 conference, which marries entertainment software with practical cognitive neuroscience.

Much of the current virtual reality (VR) research is being funded by the Dept. of Defense, which has been trying for years to help military service members who suffer from brain injuries and PTSD symptoms as a result of the wars in Iraq and Afghanistan.

Dr. Skip Rizzo from USC’s Institute for Creative Technologies demonstrated a powerful VR environment, dubbed “exposure therapy”, that places the user in a Humvee during an IED attack. In addition to the visual and auditory stimulation, the VR system includes strong low frequency waves that approximate the blast wave of an IED detonation. The hope is that allowing service members to relive these experiences in a “safe” environment, the training will tune-down the overly active stress responses many have after returning home.

VR cognitive training for emotional resilience and good coping behaviors also show some promise. Typical addiction relapse rates are very high with traditional treatments, which has created something of a revolving door (and profitable business model) with the hundreds of addiction treatment centers in the US. Lower cost VR applications could open the door to better and more sustainable outcomes for many types of addiction.
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