We are now within two years of a cure for Alzheimer’s disease.
What a brash and disruptive claim! What hubris! Yet events are coming together, underlining a new and far more complete understanding of the disease, illuminating the cause, supporting the ability to intervene, safely and effectively. We finally see a way to intervene in the basic pathology, underlining the potential to both prevent and cure Alzheimer’s disease.
But why has it taken so long? Why was Alzheimer’s disease first defined 110 years ago, and yet remains totally beyond our ability to intervene even now? Why have all other approaches, whether those of big pharma or those of biotech, failed utterly? Why has not a single clinical trial shown any ability to change the progress of this frightening disease? Why is Alzheimer’s disease not only called “the disease that steals human souls”, but also called the “graveyard of companies”? Why has every single approach (which has at most shown only an effect on biomarkers, such as beta amyloid), still failed to show any change in the cognitive decline in patients with this disease? Why have we failed universally, until now?
Because every approach has concentrated on effects, not on causes.
Currently, most approaches target beta amyloid, many target tau proteins, and some target mitochondrial function, inflammation, free radicals, and other processes, but no one targets these problems as a single, unified, overarching process. Alzheimer’s isn’t caused by any one of these disparate processes, but by a broader, more complex process that results in every one of these individual problems. Beta amyloid isn’t a cause, but a biomarker. Equally, tau proteins, phosphodiesterase levels, APOE4, presenilins, and a host of other markers are effects, not causes. The actual cause lies upstream and constitutes the root cause of the dozens of separate effects that are the futile downstream targets of every current FDA trial aimed at Alzheimer’s disease. Understanding this, we will be targeting the “upstream” problem, rather than the dozens of processes that others target individually and without success. Our animal studies support the ability to effectively intervene in human disease: when we say that we are about to cure Alzheimer’s disease, we base claim that on a clear and consistent theoretical model, supported by equally clear and consistent data.
Within the next few months, we will begin our FDA toxicity study, preparatory to obtaining an IND that will permit us to begin our FDA human trial. Our toxicity study will take 6 months and will meet FDA requirements for human safety data. Our first human trial is planned to begin one year from now and is intended to show not only safety, but a clear efficacy. We will include a dozen human volunteers, each with (not just early, but) moderate Alzheimer’s disease and our human trial will last 6 months, including a single treatment and multiple measurements of behavior, laboratory tests, and brain scans. We expect to show unambiguous cognitive improvement within that six-month period. We are confident that we cannot merely slow, not merely stop, but reverse much of the cognitive decline in our twelve patients. We intend to demonstrate an ability to cure Alzheimer’s disease clearly and credibly.
Curing Alzheimer’s requires investments of money, time, and thought. The toxicity study costs 1 million dollars; the human trial costs 2.5 million dollars. Telocyte has half a million dollars committed to this effort and at least one group of investors with a firm interest in taking us all the way through the human trials. We are close and we grow closer each day.
After 110 years, we are about to cure Alzheimer’s.