This one is from Lilly located in Indianapolis!
Brain Science: On November 30 2022, Lilly sent out a news release on a new drug for the treatment of Alzheimer's. Donanemab is a drug designed to reduce brain amyloid plaque levels and at the same time and reduce P-tau in the blood. You may recall that the build up of plaques around the brain cell is thought to be a major contributor to dementia and Parkinson. Also you may remember in previous texts we talked about the tangling of taus as also a contributor. ( see blog titled "Brain Science" and blog titled "When the Brain Breaks.) The drug is in the final phase of phase 3 study. The drug has received permission to fast track it's development. Two interesting points about Donanemab. First it treats two causes of dementia at the same time. Second, the study is a comparative study to the now available Aduhelm ( aducanumab). (see blog titled "Alzheimer's") The announcement was about how positive trials have been to this point. Studies are showing the superiority of Donanemab to Aduhem. Studies to this point have been over a 6month period so comparisons were for 6montths. Obviously the drug has not been in trials longer than that so comparisons were to a shorter period of time. 37.9% showed definite brain clearance of amyloid plaque compared to Aduhelm -treated patients at 1.6%. In the intermediate tau subpopulation the comparison was 38.5% compared to 3.8% Aduhelm. Obviously this is a significant difference. There are other significant comparisons but they require a little more explanation than what we want to do here. Through the accelerated approval pathway, the FDA has recognized that the reduction of of amyloid beta plague is a biomarker reasonably likely to predict their is a clinical benefit in the treatment of early Alzheimer's disease. The current trial is on going and will have 12-month and 18-month secondary analyses. In June 2021 Lilly announced that the FDA had granted Breakthrough Therapy designation for Donanemab.
Brain Fact:
Dementia due to Alzheimer's disease is the most common form of dementia, accounting for 60 to 80% of all cases.
There are currently over 55 million people around the globe have dementia. The number is projected to be nearly 139 million by 2050
In the US alone there was an increase of 10 million new caregivers from 2015 to 2020.
The cost of dementia is forecast to rise to US$ 2.8 trillion by 2030.
If global dementia were a country, it would be the 14th largest economy in the world.
Research shows that most people currently living with dementia have not received a formal diagnosis. In high income countries, only 20% -50% of dementia cases are documented in primary care.
Worldwide studies suggest that approximately Three quarters of people with dementia have not received a diagnosis.
So What:
We have discussed now four different drugs in the FDA approval process. They are: Butanetap, Aducanumab/Lecanemab (Aduhelm), Alzamend Vaccine, and with this blog, Donanemab.
It is so interesting that so many people with dementia have not really received a primary care formal diagnosis. That, to me, is a major issue. So what if we fined one or all of these drugs turn out to be effective. Without a primary diagnosis from a primary physician how will they be treated?
I hope you see how important it is that a diagnosis occur in the first stages of cognitive decline. All of these therapies are targeted at the early stages.
This comparative study is also interesting. I had not seen one before. It will be really interesting to see such a study of all of these together.
Again, we are living in a really interesting and significant time as related to all cognitive impairments /brain related research and development. This is a forward looking time. My hope is that it all works out well.
I need to thank my grandson-in-law for sending me the material on Donanemab. Drew works for Lilly in the research study area.
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