Alzheimers drug Tramiprosate on its way toward FDA approval
What's new on the research front for the treatment of Alzheimer's disease? And, what do the terms phase 2 and phase 3 research mean? In the last two decades, studies on the impact and effects of certain drugs have become increasingly common. In the 1990s, an explosive increase occurred in the area of neuro-pharmaceutical research, which is why it is known to many in the health community as the "Decade of the Brain". Much of this research was directed towards Alzheimers, and that trend is still in effect today.
When we discuss the new drugs being studied for Alzheimer's disease, they are commonly described as being in a phase 1, phase 2, or phase 3 research trial. Basically, phase 1 is the earliest and most basic level of research, designed to evaluate whether the proposed research is feasible (do-able). Phase 2 evaluates the safety of the proposed treatment. Phase 3 evaluates whether or not the medication does what it is supposed to do (efficacy) and further evaluates the safety of the treatment. Only after a successful phase 3 study is a treatment considered for approval by the FDA. Even then, usually a second phase 3-type study may be needed. These last two studies are commonly called "registration trials" because, if they are successful, the treatment may then be registered by the FDA.
Recently, a phase 3 study was completed on a drug called tramiprosate (Alzhemed). In a previous blog, I briefly mentioned research studies on drugs that were designed to decrease amyloid in Alzheimer's patients. Amyloid is a compound that is in the brain and is clearly associated with worsening brain function in patients with Alzheimer's disease. There are reasons to believe that patients with Alzheimer's disease may show improvement, or lack of progression, if amyloid is somehow changed within or perhaps eliminated from the brain. Tramiprosate is a drug that is thought to block the toxic effects of amyloid in the brain. It is small and taken orally. As indicated above, the first phase 3 study of this potential medication, which included 1,052 patients, has been completed. However, the results are not yet available. It was hoped that the analysis would be available by June 2007. However, the complexity of the research study is such that it will take longer for the analysis to be completed. It is exciting and encouraging for those of us involved in the care and treatment of people with Alzheimer's disease that we the results of the tramiprosate studies will be released soon. I will keep you up-to-date on this exciting research.
Other research trials of treatment for Alzheimer's disease are currently in progress and I plan on detailing them in future blogs.