Monday, May 6, 2013

Brain-Tools has partnered up with a newly established non-profit group called Hope for Alzheimer's to help get MSF to patients. This group was established by Doug Person, Greg Murray, and Margie Bachman to raise funds for research and development of treatments for Alzheimer's. The group is in the process of filing for 501(c)(3) charity tax designation which will go through by the end of the year, giving donors a tax write off for their contribution. This contribution will then go to help pay for the advanced safety studies and clinical trials yet needed to get MSF to people with Alzheimer's disease.

What's more, because Brain-Tools is intended to sell MSF for a profit we will pay every dime we receive back to the organization on completion of the project. This money will then be redistributed to a new Alzheimer's research project working on a true cure for Alzheimer's! This means that if all goes well, you not only receive a tax write off for your donation, but the donation will get used twice, effectively doubling it.

To check out the Hope for Alzheimer's Foundation website go to

Friday, April 26, 2013

FDA Discussions

I mentioned a little while ago that we had been in contact with the FDA about getting some advice on our clinical trial design. That's progressed a bit with some emails back and forth.

We also managed to get in contact with Senator Ron Wyden (OR) who sits on the funding committee of the FDA as well as the committee on aging. Dr. Summerton had dinner with him last Friday and he agreed to help us get in contact with the people we need to talk to at the FDA.

Lo and behold last night Dr. Summerton received a phone call from the FDA asking about our project.

Getting advice from the FDA in our experimental design is absolutely vital in keeping the costs down while simultaneously running an experiment that complies with the quality requirements of the Food and Drug Administration.
In the meantime Dr. Moss is trying to get in contact with Governor Rick Perry (TX) To help with a funding proposal to the states while Dr. Summerton has been in contact with Governor John Kitzhaber (OR) to also provide advice on how to level a proposal to the 50 states.

Tuesday, April 23, 2013

Our First Spot on Television

The KVIA station in El Paso Texas picked up our story yesterday. Whitney Burbank called up Brain-Tools at about two pm looking for Dr. Moss' phone number, and the story ran on the 10:00 news. It was a remarkably fast turnaround and a very well done story.

You can watch the story at their website here.

Friday, April 12, 2013

New Crowdfunding Site: We can take Credit Cards Now!

We have started up a Brain-Tools crowd funding page over at Rockethub to collect contributions to the MSF development project. This site is set up to help fund new start up projects by public contribution, just as we had intended to do with our treatment for Alzheimer's. Our first fundraising goal is $100,000 collected over 90 days which will go to developing our memory tests and pay for equipment we'll be using to safely manufacture MSF for our long term safety study (the second stage described in our funding plan).

Please take a moment to help us with the first leg of our crowd funding push to make MSF available to Alzheimer's patients. Share this site with anyone that would have interest in a more effective treatment for the debilitating effects of memory loss caused by this disease.

Brain-Tools Crowdfunding Project 

Thursday, April 11, 2013

Podcast on Alzheimer's Speaks Radio

Dr. Moss gave an interview on Alzheimer's speaks radio today which you can listen to below on his experiences with developing MSF and how we plan to proceed from there. You can also listen to the interview on the Alzheimer's speaks site here. The interview with Dr. Moss begins at 61:34.

Listen to internet radio with Alzheimers Speaks Radio on Blog Talk Radio

Monday, April 8, 2013

Assays for Memory Improvement After Treatment with MSF in Alzheimer's Patients

        I had the opportunity to see the memory assays we'll be giving to Alzheimer's patients to assess their improvement, and I loved them. They were easy to understand, could be given quickly without too much strain on the subject, and the peer reviewed research indicated they were exceptionally good at discerning memory abilities in both Alzheimer's patients and normals. The tests were researched by Dr. Awh and Dr. Vogel, and they are currently working on formatting the tests so that they can be given remotely by trained testers over Skype or a similar sort of software. This is pretty important if you're going to be testing 400 people a week over a potentially very large area. Of course in addition to these quick assessments our Contract Research Organizations (CROs) will also be using the same methods that Aricept used to test donepezil on a roughly monthly basis so that our they can determine relative effectiveness of the drugs.

        In the meantime Dr. Summerton, co-manager of Brain-Tools, has written our first letter to the FDA about helping us set up Adaptive trials, and we just got our first responses! Details will be forthcoming.

Friday, April 5, 2013

Getting the Word Out

Website Completed

        Although we've been tweaking it a bit here and there, the website has been pretty much completed, with all of the information on our project to get MSF to Alzheimer's patients available now. One of the key features up there right now is an animation Jon Perry of Stated Clearly created for us to explain the mechanism of MSF's restoral of memory in sufferers of Alzheimer's. The animation explains why MSF performs so remarkably compared to what's available on the market, and does so for a general audience.
        With the completion of the website we've started focusing on how to best disseminate our project to the public. Because we rely on contributions from the public as opposed to traditional venture capitalists we have a lot more stake in having our project heard about by private individuals. Whereas a mainline Biopharmaceutical company might put out a few press releases to drum up enthusiasm in their existing investors, we need everyone with a stake in Alzheimer's treatments to hear about us. Currently Dr. Moss is working with a PR consultant and some volunteer assistance from his daughters to write letters to talk shows, podcasts and blogs asking if they'll share our story. We should start sending the letters out within the next few days, so check back here to see if we end up on anything you listen to. If you have any suggestions for slightly obscure podcasts or talk shows we should write to, please send them to me at

And now for the video I was touting in the first paragraph!

Wednesday, February 27, 2013

How do we prove to the FDA that MSF Works?

            This was a pretty crucial question to answer. Without having a good idea of how to show quantitative memory improvement, an Alzheimer's treatment would be dead in the water, and while Dr. Moss had designed numerous experiments as well as run a clinical trial for efficacy, all of these were with small samples. The testing for memory improvement needed to be streamlined so that we could easily collect data on as many as two hundred subjects through quick and easy tasks that wouldn't put too much strain on either the Alzheimer's patient or their caretaker. One of the big concerns when running large scale trials is that if your tests are too onerous, you'll have a large dropout rate and may end up with an insufficiently representative sample to satisfy a regulatory body like the FDA.
            With this in mind we contacted Dr.Edward Awh and Dr. Edward Vogel at the University of Oregon. Both Eds have existing labs that study visual working memory and attention, two major faculties damaged by the progression of Alzheimer's disease. They accepted the task of putting together FDA compliant tasks that could demonstrate a change in a person's basic physiological ability to remember things, even after repeated exposure to the same procedure (ie, they can account for the learning effect).

Excerpted from an email to me by Dr.  Vogel:
The plan for assessing the efficacy of MSF by testing memory functioning in Alzheimer's patients.

Our general plan for doing this involves two basic components:
1. Clinician-administered tests (once every 3-4 weeks during the study) which will include the ADAS-Cog (a battery of cognitive tests for alzheimer's that has been the standard measure in nearly all clinical trials of cholinesterase inhibitors); and one or two questionnaires regarding Daily living activities and function to be filled out by the patient and caregiver. These tests should take approximately 45mins to 1 hr to complete.

2. Remotely-administered tests via computer (once per week during the study) of memory and cognition which will include assessment of picture memory, paired-association with words, delayed free recall of words, and the COWAT (Controlled Oral Word Association Test) which measures the individual's ability to fluently generate words of a particular type (e.g., say all the words you can think of that start with the letter "F"). Together, these tests will take approximately 20mins to complete.     

            He ended the email suggesting that they should be finished with the test development process by the end of March, putting us well on schedule to proceed as soon as the long term, FDA compliant toxicity studies are completed.

I'll admit I'm kind of curious to take one of these memory tests myself. I'll probably keep the results confidential though.

Friday, February 8, 2013

The Story So Far

There are about thirty years of backstory to this project which you should read about either in Dr. Moss' book, or for a quick overview, in the excerpts section on the brain-tools website.  The part where we (braintools) came into the picture, however, was in October of 2012. Dr. Moss and Dr. Summerton had already agreed to collaborate on finally turning the drug Dr. Moss had developed and tested into a workable treatment for memory loss in Alzheimer's patients. The trouble that's faced Dr. Moss over so many years was the lack of patent protection afforded to the MSF drug, making it cost-prohibitive for any big pharmaceutical company to carry through a 100 million dollar phase three clinical trial, despite its unprecedented efficacy in restoring the memories of Alzheimer's patients. Dr. Summerton had discovered a long forgotten congressional bill called the Orphan Drug act, passed in 1983, which was developed for the specific purpose of getting highly useful, but non profitable drugs on the market. The bill was originally developed to cover drugs that treated life threatening illnesses that affected a very small patient base like Muscular Dystrophy, but since has been expanded to cover any drug that can provide great social benefit but not enough profit to cover the costs of clinical trials. The Orphan Drug act mandates that the FDA collaborate with drug development groups to help minimize the cost of clinical trials and streamline the process, while simultaneously offering a seven year guarantee of protected market status to help recoup losses. For us this ends up being four years of market protection as phase two and three clinical trials are expected to take about three years.

Because major pharmaceutical companies have passed on the drug, we at brain-tools may be the last hope to get MSF (Methane SulfonylFluoride) into the market. Our plan is discussed in detail here, but the key element is the reliance on crowd funding instead of a traditional equity investment. With funds raised through contributions we will not be accruing large debt to venture capitalists. Between this and the reduced costs of clinical trials through the Orphan Drug Act we can offer a contractual guarantee that we will keep prices of MSF affordable to everyone, even those without health insurance or on social security. This is a guarantee that other avenues of drug development cannot offer. Perhaps an even bigger advantage of this method is that it will open the path for other companies to follow a crowd funding/Orphan Drug act model, allowing other potentially lifesaving drugs that have fallen through the cracks to make it into the market.

It's an exciting prospect, to say the least.