welcome to the organic green doctor blog

i am a family physician who was diagnosed with
early mild cognitive impairment(mci) amnestic type on december 21, 2010
this is a precursor to alzheimers disease
because of this diagnosis i have opted to stop practicing medicine
this blog will be about my journey with this disease
please feel free to follow me along this path
i will continue blogging on organic gardening, green living,
solar power, rainwater collection, and healthy living
i will blog on these plus other things noted to be interesting

Friday, January 27, 2023

alzheimers news-why donanemab didnt get approval


alzheimers disease starts with amyloid accumulating in the brain
the theory is if you remove the amyloid plaques early enough in the disease you can alter the course of the disease

enter the antiamyloid monoclonal antibodies that bind to amyloid or the amyloid plaques and removes it from the brain
hoping doing so will make a difference

there are now 3 monoclonal antiamyloid antibodies in the running for treatment of alzheimers disease
these drugs will not cure alzheimers but it may slow down the symptoms

first is my drug aduhelm or aducanumab
it was approved for use in early alzheimers disease although the approval process was sketchy
the fda approved it but the medicare medicaid folks called cms wont pay for it unless its used in clinical research
they also have required them to do a longer clinical trial to prove if it really works

my study is called the embark study where i have received around 25 monthly infusions of aduhelm or aducanumab after18 months of placebo 
it will report out in 2 years
it  probably will show that it reduces memory decline by about 22% but will have higher aria or microbleeds than the other two
it also is slower in removing the amyloid than the other two

my guess is that my drug aduhelm or aducanumab will not be the one to use even though it does the job

second is leqembi or lecanemab which was just approved by the fda for use in early alzheimers disease
it removes the amyloid faster than aduhelm does
it reduces memory decline by about 27%
slightly more than aduhelm does
it also has the side effect of microbleeds or aria but not as much as aduhelm does
medicare medicaid or cms has not made a determination if they will pay for it
some think it will approve paying for it 
its given as a twice a month infusion

now third is lillys drug donanemab
the fda has decided not to approve it use early until more studies are completed
its expected to give its full approval later this year 

donanemab worked too good at removing amyloid
around 100 or so folks were given donanemab but before the full year was up the measurable amyloid seen on amyloid pet scans wqs all gone
so the donanemab was stopped
the fda said they didnt have enough folks complete the year long study
later this year they will have enough data to please the fda

it is given as a monthly infusion
its side effect profile is similar to leqembi or lecanemab

seems odd doesnt it that it worked too good so the fda woulnt approve it

its felt the fda will give full approval and that medicare medicaid will likely approve it also
its given as a monthly infusion

so eventually we will have 3 drugs that are antiamyloid monoclonal antibodies to chose from

they all will cost about the same 
a lot of money around $20,000+ a year
about 2-3 months cost to be in a nursing home or memory center

right now 
which would i chose to take

probably donanemab
it works better than aduhelm or aducanumab and maybe better than leqembi or lecanemab
the plans are to give it intermittently based on the amyloid load in the brain
lecanemab has to be given every two weeks while the other two are given monthly
aducanumab has worse aria or microbleeds

i would probably chose donanemab then leqembi or lecanemab then aduhelm or aducanumab

all 3 of these are doing clinical trials in folks who are prealzheimers or prodromal alzheimers
that means those who have amyloid plaques in the brain on amyloid pet scans but have no memory issues yet
maybe attacking the disease before symptoms start will allow these 3 drugs to be more effective

the fact that i will have 3 drugs to chose from in a couple of years shows we are making progress

the organicgreen doctor

follow me on twitter
follow my blog facebook page



No comments:

Post a Comment