Alzhemed: Keeping Track of Alzheimer's Treatment Research
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, drug studies have become increasingly common. The 1990s was the "Decade of the Brain," and an explosive increase has occurred in the area of neuro-pharmaceutical research. Part of this increase, currently present, is in Alzheimer's disease.
When we discuss the new drugs being studied for Alzheimer's disease, it is common to see that they are in or have finished a research trial that is typically described as a phase 1, phase 2, or phase 3 clinical 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 two studies that are required by the FDA 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 SharePost, I briefly mentioned research studies 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 can look forward to the results from this research becoming available 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 will be described in future SharePosts.