For the next few months here at Quality Family Care, we are raising money to help bring attention to Alzheimer’s awareness and research. In the home health care industry, it is one of the most difficult struggles watching the patients you love slowly slip into a void of confusion and forgetfulness. There is nothing more emotionally challenging to watch a family member or loved one slip into the foggy haze that is one of the most baffling diseases in the medical and home health care world. That’s why the team here at Quality Family Care is dedicated to help support the advancement of medicine and treatments needed to help combat this global problem. So, when we hear about new advancements towards dealing with this issue, it gets us excited.
New breakthroughs are emerging as the FDA pushes the modernization of approaches used to research and develop new treatments. Much like this Alzheimer’s gene breakthrough.
The FDA has prepared new standards for its Alzheimer’s research drug approval process. In response to the information learned throughout many years of research study, the FDA is positioning a higher priority on initial discovery and the function of biomarkers in Alzheimer’s. FDA Modernizes Approach to Alzheimer’s Research
FDA Redefining Effectiveness for Alzheimer’s Research
The Food and Drug Administration (FDA) is altering its approach to assessing drugs for Alzheimer’s disease and other neurological disorders. Since the 1990s, the FDA has called for clinical trials to verify that a new drug can enhance the cognition and functionality of an individual with the disease. Nevertheless, as researchers recognize more about the attributes of Alzheimer’s, it has become obvious that this specification will not work if we are to halt Alzheimer’s before it begins.
Within the earlier phases of Alzheimer’s and in some cases even into the mid-stages of the illness, there is typically no issue with daily functionality. As a matter of fact, specialists agree that functional incapacity is often not acknowledged until Alzheimer’s has advanced into the third phase.
Therefore, Alzheimer’s drugs were failing to satisfy FDA requirements because they could not show an advancement in functional impairment because there was no functional impairment existent in early Alzheimer’s.
New Method Integrated to Various Phases of Alzheimer’s.
In most situations, the FDA calls for only one endpoint. This is now the recommendation being made for Alzheimer’s.
The FDA is aiming to improve its process, considering what we now know about the condition to prepare standards for three stages of early Alzheimer’s and the drug progression for each phase.
According to recently drafted FDA guidelines:
- Men and women with Stage 1 Alzheimer’s show no medical signs and symptoms of the condition but do have biomarker confirmation of it. Biomarker evidence consists of positive PET scans revealing beta-amyloid or tau proteins. For this phase, enhancements in biomarkers would function as the grounds for drug approval.
- Individuals in Stage 2 of Alzheimer’s reveal biomarker evidence of the disease and indications of cognitive problems but are not showing signs of functional impairment. For drug approval in this phase, the FDA will take into consideration “highly warranted arguments” for utilizing only enhancements in cognition as a standard.
- Men and women in Stage 3 Alzheimer’s have biomarker proof of the disease and show cognitive and functional impairment. For these tests, approval would be based on enhancement in cognition and functionality.
The modified FDA guidelines mirror decades of analysis and research studies, revealing the significance of early identification and the function of biomarkers in medical diagnosis.
Researchers performing scientific tests must now define and pinpoint the stage of Alzheimer’s in each individual at the time of registration and use biomarkers for individual selection and to keep track of disease progression in addition to the efficiency of the medication.
How do you think the new FDA criteria will impact Alzheimer’s research and the quest for a proper treatment? Quality Family Care would like to hear your thoughts in the comments below.
If a family member or loved one is affected by Alzheimer’s and you are looking for in-home health care options, call QFC today at 877-513-7156 or visit us on the web to help troubleshoot your next step at www.QualityFamilyCare.com.