ALZHEIMERS NEWS-STAUS OF MY BIOGENS ADUCANUMAB
the body then develops an inflammatory response to this damage and this inflammatory response causes more damage
as the disease progress the damage get worse and worse
the goal is to stop the three step process before it happens
enter biogens aducanumab drug which is a monoclonal antibody against amyloid derived from older folks who dont get alzheimers disease
this antibody is then made in the lab and give intravenously to patients
i entered the aducanumab study about 4 years ago
i received 18 monthly intravenous doses of placebo followed by 7 months of the high dose aducanumab before the study was halted
it was restarted this spring but was stopped again due to covid 19
we all are waiting to find out when the study will be reactivated
biogen applied to the fda for approval for its use of aducanumab in treating patients with alzheimers
their study showed when given the higher dose that i was on that
the amyloid seen on pet scans was removed
functional measurements of how patients functioned were improved or the rate of decline was slowed
memory testing showed the same thing
those with alzheimers should have a decline from year to year some faster than others
tau protein scans showed less tau tangles
inflammation in the brain was slowed down also
so there was slowing of the measures of the disease
patients and families and doctors noticed improvements
if you look at how aricept (donepezil) helps to slow down the symptoms of azheimers i dont know that it works better than aducanumab
yet its approved for use
in order for aducanumab to get approved for use by the fda
an fda advisory panel meets which it did last friday
it voted to not recommend that aducanumab be approved by the fda for use in alzheimers disease
it cited costs and not effective enough as the major reasons for voting against aducanumab
now the fda panel that makes the final decision will decide some time between now and march
it could approve aducanumab for use
however
usually if the fda advisory panel doesnt vote for it then the full panel doesnt usually vote for approval
there are however powerful influencers in the alzheimers world who want this drug to be approved
one is the alzheimers association a big mover in the alzheimers world and who has a lot of political influence wants this drug approved
several well known alzheimers researchers support the approval of aducanumab for use against alzheimers
many have seen how it has slowed the disease down in their patients
it is possible the fda panel will approve it
it is possible that the fda panel may require biogen to do a longer 4 year study then they will decide on its approval
it is possible that the fda panel will say no and thats it
my guess is they will either approve it
and or
require a longer term trial
so how does this affect me
if its approved i will receive it monthly
if biogen has to do a longer clinical trial then i will be in that trial for whatever time the study lasts
hopefully i will find out monday when i go to ucla
what do i think the fda should do
i wrote a statement and submitted it to the fda advisory panel
i think they should improve it
i think it works as well as aricept (donepezil) does
i realize it wont cure alzheimers but neither does aricept or namenda or exelon or razadyne which are approved for use in alzheimers
no matter what happens i will get at least 2-4 more years of treatment with aducanumab
ill take whatever i can get
whats the other options
right
i see alzheimers as a terminal disease like a terminable metastatic cancer
if i dont die of a heart attack or stroke or cancer thats what i will die from
we give palliative care to terminal cancer patients to slow down the disease lessen pain and give patients a few months or a few years longer to be with their loved ones
so why cant us alzheimers patients with a terminable disease not have access to a drug that might slow down the disease some
it can be the difference of seeing ms b eg graduate from kindergarten then graduate from elementary school then graduate from junior high school then if im lucky graduate from high school
aducanumab might allow me to see more than one graduation
thats why it should get approved
the organicgreen doctor
Yes, Let's hope pray and advocate for this approval.
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