biogen aducanumab study-my exit interview

BIOGEN ADUCANUMAB STUDY-MY EXIT INTERVIEW

the day before my birthday in march 2017 i got a phone call
could you come in tomorrow for your first infusion in the aducanumab study
i thought that day what a great birthday present to get my first infusion on my birthday
it would be the first of 25 infusions i would receive each month

i started this biogen aducanumab study at the university of texas southwestern alzheimers research center then about halfway through i switched to the ucla alzheimers research center when we moved here to santa barbara
i even flew back twice to dallas after we moved until i could get final approval to start at ucla

when aducanumab got approved to start this phase 3 study
everyone was excited
patients researchers lay folks since it looked like this might be the drug that really might make a difference to slow down this disease in those of us diagnosed with it
yes
there was a buzz of excitement

aducanumab is an antibody against the beta amyloid that has accumulated in the brain over years
we now know its what starts the alzheimers disease process
it seems now we know that the tau protein that becomes unraveled when the amyloid damages cells this tau starts spreading like a wildfire through the brain
it seemed removing the amyloid might slow things down
that was the hope of all involved

i must say i was excited and hopeful

to get in the study you have to have documented memory loss to a certain level
i qualified based on my initial evaluations when i was first diagnosed in 2010
also to get in this study you have to have a positive amyvid pet scan for amyloid
the hallmark of alzheimers disease
my amyvid pet scan was positive so i got in

it seems if you get treated with the aducanumab infusions for a year that your amyvid scan will be read as negative
maybe those on the low dose would have scans read as almost negative
so
the aducanumab removed the amyloid
it did its job
but
did removing that really make a difference
or
was it being removed too late

preliminary studies implied that it made a difference after a year

so over two years ago on my birthday in 2017 i and my wife she was very very very excited
what a birthday present


after my first infusion i developed headaches for a week and fatigue
headaches were a known side effect of this drug since you could get microbleeds in the brain as the amyloid was being removed
i also at that time had developed a flare up of my iritis which causes the same symptoms

i must say i was excited to have those bad headaches
but
was it the aducanumab infusions or the iritis
now
after yesterday i know the answer to that question

i had a 67% chance of receiving the real drug for 18 months
i had a 33% chance of receiving the placebo for those 18 months

then
after 18 months all placebo folks started getting the real drug
after 18 months all those who got the real drug got to continue the same dose

basically we all knew we got at least 7 months of the real drug
before
they abruptly stopped the study with no explanation
now after 4 months no explanation has been given but hopefully soon all will find out why it was abruptly stopped

imagine if you had terminal cancer for which there was no cure
thats what alzheimers disease is is like a terminal incurable cancer
then
there was a study that all said this is probably the treatment that will slow down or cure this disease

that was the aducanumab study

well
we found out in march that that treatment that possible cure wasnt the one

imagine how you might feel

well thats how i felt and my wife she felt and the researchers felt

so
yesterday
we made that 2 hour journey to ucla for our final exit interview

as we were zooming along the 101 down to ucla i watched that pretty stretch just south of santa barbara where you drive along the beach for several miles
where you can look out on the ocean watching the waves crashing on the beach
well i was thinking
i think im done i dont want to do this anymore
ive been in a study now for almost 9 years getting all those memory tests all those mri scans all those amyvid pet scans those spinal taps all that blood thats been drawn all those miles we have driven to get to those studies

yep
i looked out over those waves moving to the beaches
i thought
im done with all  of this

ive dodged the bullet so far
we have a good life
im comfortable with all of it
im done
lets just enjoy ourself
we have too much going on in our lives now

so
to the exit interview
i underwent a hour or more of memory testing
i know exactly how well i did as i do them
i didnt miss anything on the memory testing
if i was in a neurology office and they were testing me and they didnt know my history
they would look at my memory testing
and
say
your memory is normal

then
i had 10 large vials of blood that i calculated to be about 100 cc about half a coke can of blood
thats something that i have had done in this biogen aducanumab study about 30 times
do the math
thats 2 liters of blood in about 30 or so months

then
to the neurologist
the one i saw is clinical
like joe friday
just the facts mam
the neurologist i see for my care and who is the research director is more non clinical
like i hope i was with my patients

she at the end after updating my history and doing a neurological exam
flipped back all the papers in the file
at the back was a letter from the aducanumab folks
she said
you got the placebo
sort of matter of fact like
not quite like i would have told someone
but joe friday like

which was ok with me
i and my wife she felt sort of slapped in the face
i always felt i didnt get the placebo

so that means i got 7/12 of the doses it would take to make my amyvid pet scan negative now
my guess is that my last amyvid pet scan was positive still but not as strong as in the beginning

what does that mean
i do feel that removing all the amyloid if one lives longer will make a difference
i do know now that the time to remove the amyloid was 20 or more years ago
not today

so
we left yesterday with some sadness maybe a little down
but
at least i know i got some of the real drug for 7 months which removed a lot of the amyloid
maybe we dont know if it will help some down the road

i have a decision to make
do i want to do this again
make this commitment for another study
or
just say thats it
im done
ill just do all those healthy things one needs to be doing to slow the disease down
at least those things have been scientifically proven to slow it all down

im cognitively normal right now and in good health otherwise

should i just live my life and enjoy it and not look back

im not sure
i will decide in 6 months when i qualify for another study

i guess i shouldnt give up trying to slow this down
trying to advance our knowledge about this disease and what to do about
i must say it does feel good to be part of this movement

the organicgreen doctor