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Give Alzheimer's Patients Their Memories Back

by helping to complete development of MSF

Breaking News of MSF Success

Newly published experiments (2017) show that MSF completely avoids the unbearable side effects of nausea, vomiting, and diarrhea that have made all the old cholinesterase inhibitors (Aricept, Exelon, and others) completely useless. Through the breakthrough of MSF, for the first time in the history of Alzheimer’s disease, cholinesterase inhibitor therapy for Alzheimer’s can be used at any dose needed to effectively treat dementia without the risk of intolerable side effects. There are no other cholinesterase inhibitors that can come close to matching these powerful therapeutic effects of MSF in the treatment of dementia.

In these decisive experiments, monkeys were treated for several weeks with doses of MSF up to eight times the human clinical dose – the dose that produced exceptional improvement in double-blind, placebo-controlled clinical trials – without the side effects. This is truly a breakthrough in cholinesterase inhibitor treatment of Alzheimer’s. Please read about MSF’s superior mechanism of action in the rigorously peer-reviewed published version of this 2017 paper as it appeared in the Journal of Alzheimer’s Disease* by clicking on the link below:

Cholinesterase Inhibitor Therapy in Alzheimer’s Disease

*Moss, D.E., Perez, R.G., and Kobayashi H. Cholinesterase inhibitor therapy in Alzheimer’s: The limits and tolerability of irreversible CNS-selective acetylcholinesterase inhibition in primates. Journal of Alzheimer’s Disease, 2017, 55(3) 1285-1294.

IMPORTANT UPDATE ON THE STATUS OF MSF DEVELOPMENT

All of Dr. Moss’ patents for the use of MSF for the treatment of Alzheimer’s dementia have now expired (as of August of 2016). While the expiration of patents is often viewed as a problem, this is not true with MSF. For the past 20 years, all MSF patent rights have been licensed to ineffective companies, blocking MSF development. The expiration of these patents now releases MSF from 20 years of “patent purgatory” and MSF is now available for development by Brain-Tools, LLC, which is dedicated to finishing the development of MSF and to making a fundamental improvement in the treatment of Alzheimer’s.

How can Brain-Tools and its partners recover an investment in MSF without the market exclusivity provided by a patent? MSF qualifies as a “New Chemical Entity” under both US law (21 CFR 314.108) and the European Union Data Exclusivity Directive (Directive 2004/27/EC. These regulations will allow for 5 years of market exclusivity in the US (see reference) and 10 years in Europe (see reference) after market approval for MSF even without any patents. These guaranteed periods of market exclusivity are equal to or longer than protection provided by most patents. At its late stage of development, after two Phase One trials and one Phase Two trial with clearly demonstrated efficacy, MSF is an excellent candidate for market approval and the recovery of investment under the “New Chemical Entity” regulations, strong non-patent based strategies. This is the avenue forward now that the patent protection has expired.

Brain-Tools is actively soliciting partnerships with venture capitalists or pharmaceutical companies for pushing MSF through the final stages of development and on to marketing approval in the U.S., Europe, or other countries.

For more information, please contact Dr. Don Moss at don.moss@brain-tools.com or at (970) 629-3927. More information can also be obtained from a non-confidential Brief Guide to MSF at the following link:

Brief Guide to MSF



A Superior Drug for Alzheimer’s

The Problem

Six million Americans suffer from Alzheimer’s today, and it is estimated that 1 of every 5 of us will eventually be victims of this memory-destroying disease.  Currently, the principal treatments for Alzheimer’s are drugs which correct a specific deficiency known to cause memory loss in the brains of Alzheimer’s patients.  Such drugs are not a cure, but they help counter the memory decline characteristic of this devastating disease.

However, currently-approved drugs for reviving memory, such as Aricept, are only poorly effective for reviving memory and they are plagued by serious dose-limiting side effects, including cramps, diarrhea, nausea, and vomiting.

 The Solution

Instead what is needed is a drug which revives memory far more effectively and is essentially free of serious side effects.

Such a drug exists.  It is Methane Sulfonyl Fluoride (MSF) and it has already been tested in Alzheimer’s patients where it provided unprecedented improvements in memory, caused virtually no side effects, and essentially gave patients their minds back for a few precious years.  Following is a brief recounting of the life-changing benefits which MSF provided to one 75-year-old Alzheimer’s patient.

Fred was the first Alzheimer’s patient to receive MSF.  When first screened to see if Fred might benefit from MSF he scored only 6 on the Mini-mental Exam, while a normal person would get a perfect 30 on that test.  With such a low score it was doubtful that MSF, or any other drug, could help Fred because he might be too demented to be helped.  While Fred could remember his wife (his constant care giver who had enrolled him in this study), he could not remember what his career had been or where he lived.

After a few weeks of MSF treatment exciting changes began to occur.  Fred accurately remembered having gone to the symphony with his wife the previous week, and becoming frightened on his way home. After more weeks of treatment Fred began to regularly read a newspaper with apparent comprehension.  He became more like his old self, grumping about what he read in the national news, and complaining about a report of a drop in the price of a stock he remembered he and his wife owned.

At his wife’s request, Fred continued on MSF for more than two years after the end of the clinical study (under a compassionate use exemption).  During those two years he showed a lasting and remarkable recovery with a good quality of life.  However, after those two good years he finally succumbed to steep mental decline as he passed the point where MSF could compensate for the progressive destruction in his brain due to Alzheimer’s disease.

MSF is not alternative medicine, or holistic medicine, or a dietary supplement based on anecdotal stories and unfounded hope.  MSF is a mainstream pharmaceutical rooted in well understood science of memory loss in Alzheimer’s patients.  In the brain it increases availability of acetylcholine, the neurotransmitter whose deficiency is known to be the main cause of memory loss. The great success of MSF is due to its remarkable selectivity for the brain, thereby avoiding side effects elsewhere in the body.

MSF is based on 35 years of research by Dr. Donald Moss, described in his newly-published EVVY award winning book, Alzheimer’s: My Journey to a Next Generation Treatment.  MSF has been extensively tested in rats, dogs, and monkeys, and most results are published in peer-reviewed journals.  And MSF has been through three successful human clinical trials costing several million dollars, and results are published in the respected peer-reviewed journals: “Alzheimer’s Disease and Associated Disorders, Vol. 13, Page 20 (1999)”; and, “British Journal of Clinical Pharmacology, Vol. 75, Page 1231 (2013)”.

Two Phase I safety trials have shown that MSF is virtually free of the serious side effects which plague the FDA-approved drugs currently used for treating Alzheimer’s patients.

And a double-blind, placebo-controlled study in Alzheimer’s patients showed that MSF achieves about three times greater memory improvement compared to Aricept, the leading drug currently prescribed to Alzheimer’s patients.  Of special note, MSF achieves this unprecedented memory revival without causing significant side effects.  A short animation explains in non-technical terms why MSF is superior, how it achieves its unprecedented memory revival, and the novel mechanism by which it achieves its high selectivity for the brain – which is essential for avoiding serious side effects elsewhere in the body.

 Another Challenge

If MSF is such a great drug why is it not available to patients ?   The short answer is MSF development has stalled due to lack of funding.  Conventional funding has dried up because the patent on use of MSF (owned by the Univ. of Texas) is nearing the end of its 17-year life span.

 A Way Forward

To rescue MSF, Dr. Summerton and Dr. Moss recently founded Brain-Tools, LLC, which is dedicated to completing the testing of MSF, obtaining regulatory approval, and then producing and distributing MSF at low cost and an optimal dosage for each patient in order to assure maximum benefit for every patient.  To get started, Dr. Summerton contributed $1 million to fund the first stage of this program to complete MSF development.

We believe successful completion of this MSF development program will:

a) provide dramatic memory recovery for millions of Alzheimer’s patients – giving them their lives back for a few precious years; and,

b) save tens of billions of dollars every year in reduced costs of caring for patients whose memories have been revived by MSF.