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

Wednesday, May 12, 2021

my story revisited #86-will they get approved


when i wrote this blog 8 years ago i had just started to read about these new infusions of antibodies against amyloid that showed promise in slowing down or treating alzheimers disease
this was before the studies had started

this is when i put this form of treatment on my radar
i settled on biogens aducanumab as the most likely one that would be available for me and that might make a difference

lilly solanezamab pfizer bapineuzumab roche gantenerumab genetech grenezumab pfizer ponezemab biogen ban2401 lecaneumab and finally my drug biogen aducanumab was being discussed back then and later in this 2019 article 

i chose aducanumab
i think i chose right
its the closest to being approved

later donezumab is right behind aducanumab and may actually works slightly better
aducanumab is due for final fda approval or disapproval by the fda in june

when i wrote this blog below in 2013 is when i started looking closely at these antibody treatments

i tried to get in the solanezamab study but was denied since i was either not advanced enough or was too advanced 
one study was on moderate alzheimers and the other was on prealzheimers patients
i was in between those two

the result
i was later allowed in the aducanumab study 

the fda during this time started allowing companies to do studies on drugs that wouldnt cure alzheimers disease but would or might slow it down

in the alzheimers world slowing it down is acceptable

in the blog there is a link to an article on the indian community in colombia who has the highest instance of alzheimers in the world
a local ucsb scientist has been involved there for years
the article is an interesting one on that colombian community stricken with this horrible disease

one of these antibody drugs is being used there to see if it will slow things down
these results are just now starting to be reported
they may not work well in these early onset alzheimers patients

i have late onset alzheimers disease
my aducanumab may help to slow it down
the aducanumab study i am about to restart may tell if thats true or not
the fda may approve this drug anyway in june

we arent after a cure just slowing it down is good for us in the alzheimers world


thanks to those guys and gals at the fda for plans to
approve new treatments for alzheimers treatment

previously researchers had to prove patients would improve
with the new treatment to think and remember and to show
improvement in their day to day activities

eg aricept (donepezil) does this but doesnt do it for very long
and does nothing to alter the course of the disease

so finding treatments that the fda would let them test was like
only approving drugs that might work on obviously terminal
cancer patients
the success rate would be low if at all and few companies or
researchers would be interested in investing their time and
energy into developing a drug that probably wouldnt work anyway

alzheimers disease according to the beta amyloid theory really starts
20+ years before the symptoms start
when that beta amyloid accumulation occurs and when its associated
tau protein destruction cell inflammation tangles and plaques start
thats when the time to attack the disease
when it starts

eg in my mothers case it would have been when she was in her late 40s
and early 50s
in my younger brother probably in his early 40s
in me if i do have alzheimers disease it would have been in my
late 40s when i was in the prime of my career

so now drug companies will be able to develop these new
treatments to attack the disease before it gains its foothold

previously researchers were impeded by the old fda regulations and
feel that new research will now go forward to possibly provide
treatment early to slow or prevent this awful disease

two studies are starting this spring
one is on a groups of colombians who are
genetically programmed to get the disease in their early 40s but who
have no symptoms yet
time will tell if using the alzheimers vaccine in this group will
slow down or prevent alzheimers disease

the other study will be using the old anti skin cancer drug
bexarotene which worked in the alzheimers worms and the alzheimers
rats such that the disease did not develop
it will be used in patients early on in the disease  process

maybe this new fda change will help speed up the pipeline for new
treatments and ways to prevent the disease

there is some hope for future generations
i havent seen anymore about bexarotene as an alzheimers treatment 

some of the anybody treatments like solanaezamab or lecanemab or donanezumab may end up at the fda for approval like aducanumab is now

time will tell

the organicgreen doctor

No comments:

Post a Comment