my story revisited #82-my biogen aducanumab study start then restart

MY STORY REVISITED #82-MY BIOGEN ADUCANUMAB STUDY
START THEN RESTART

yesterday after two years of waiting my wife she and i jumped in our car and made the almost 100 mile drive to ucla to begin the reevaluation to be reentered into the biogen aducanumab study officially named
biogen embark 304 study
click on this link to read abut the study in clinical trials.gov

its title for those scientific folks is 
phase 3b open label multicenter safety study of aducanumab in subjects with alzheimers disease who had previously participated in the aducanumab studies

a few years before i wrote the two blogs below i identified this study as the study that i wanted to be in 
looking at my diagnosis and where i was with that diagnosis 

it aducanumab was the best drug that had the best potential to help me slow this down

i realized that when i made the choice to do this drug study there would not be another one that i would qualify in the future for that would help me

it was my last chance actually

when things progress too far its too late for any medication to help 

in 2016 i was still in that window of time where i could be helped
in 2021 i am still in that window but i have lost time since i got put in the placebo group for 18 months then got only 7 months of the real drug

two years ago the study was stopped abruptly and never restarted because of the covid 19 pandemic

so basically i have lost 3 1/2 years which in alzheimers time is a long long time

luckily since 2016 i havent deteriorated any in my memory 

im just hoping that what little real drug i did get helped some

i realize that getting another two years may make a difference in slowing down the disease
or
as we will find out in two years if it doesnt help any at all 

so before we drove down yesterday to ucla i reread my old blogs below to review what i was thinking before and after my 2016 visit

i realize then and i realize today that this is my last chance to receive a drug that may help

eg i was told about one of my fellow participants that had progressed too far with his disease in the time since the study was paused that now he is too advanced with his disease to be in the study 

how sad that family must be

this summer in about two months in june the fda will render its final decision on whether the aducanumab will be approved for use in mci and early alzheimers disease
if it does i will be ahead of the game as i will have had over a year of treatment already with aducanumab

if it gets approved for use it will overwhelm the infusion centers in the united states since the demand for the aducanumab infusions will so large

so i had to redo all my testing to be reconsidered to be approved to be in the study

yesterday i did over 6 hours of memory testing well a lot of memory testing and labs and neurological evaluation and a lengthy review of the study 
like before it was tiring
mentally not physically

i fell like that i got near normal memory testing
if i was being seen for an initial memory loss evaluation i would probably be told that i was ok
however
when you do the amyloid pet scans and the tau protein pet scans
they tell a different story 

all the evaluations done yesterday will be sent to biogen to review
next week i will have an mri to make sure nothing else has shown up in my brain over the last two years

if accepted in the study 
then
i will have an amyloid pet scan for amyloid followed by a tau protein pet scan for tau 

hopefully my amyloid pet scan will show a reduced amount compared to the initial amyloid pet scan i had in 2016 and later

i havent had a tau protein pet scan before
it should be positive and will show how wide spread my disease is in my brain

i will not be allowed to see these scans or see the results

i would like to see them but thats not the way the game is played

if approved after all this then i will get monthly infusions for the next 24 months of aducanumab

i will have a total of
9 mris
2 amyloid pet scans
3 tau protein pet scans
lots of labs
lots of memory testing

yes is how i answer the question below

will it be worth it
__________
12-16-2016
ALZHEIMERS NEWS-TODAYS THE DAY
 
two weeks ago the alzheimers vaccine study on solanezumab came out
the results werent promising
however there was a 15% improvement noted in those folks
with mild alzheimers disease
this vaccine an antibody against beta amyloid doesnt go after the
plaques that form from beta amyloid in the brain
my drug does though
also
it appears that for this stuff or any new alzheimers drug to be
effective
it has to be used in folks like me with minimal disease
or
those folks like some of you that have prodromal alzheimers
ie
you just dont have symptoms yet but the disease process is
going on and has been for several years

once you get full blown alzheimers disease it may be too late
for a treatment

the solanezumab study called a4 results will be out in a few years
its on prodromal folks

if any of  you saw the 60 minutes show on alzheimers disease
that was a story of using one of these drugs called crenezumab
in a large extended family of folks in colombia who will get
alzheimers since they carry the dominant alzheimers gene

this one works more like the one thats being used in the study
i have been trying to get in

well
todays that day
i passed hurtle number one
i got past the nurse screener
i have been accepted to enter the prescreening part of their study
on
aducanumab

this one i think is the most promising of all the drugs so far
 
here is a npr article on aducanumab

this last week at a large alzheimers conference in san diego
the data from its phase 1 study was discussed

in folks with minimal symptoms
like me
not only did the beta amyloid get removed from the brain plaques
and the cs fluid around the brain
but
folks memory stayed the same or got better
the placebo folks who didnt get the drug
their memories deteriorated

there is a memory test commonly used in doctors offices
called the mmse
you get a score of 0-30
placebo folks deteriorated almost 2 points
treated folks didnt change or declined much slower
based on which dose of the drug they got

so for me i would accept no change or mild decline

the alternative to doing nothing
well
thats not good
its real bad

so today i get started on several more hurtles

today
my wife she and i make the trip to dallas
to the alzheimers center at ut southwestern
to start my journey
one i have been hoping for for 6 years now

it starts with an interview with the research nurse
asking me and my wife she lots of questions
all 1000+ of us in this national study go through the same thing

then
this visit or maybe the next visit if i pass this one
i get a lot of blood drawn
240 ml or 8 oz

then
i undergo that torture test
called neuropsych testing
which includes the mmse and other memory tests that the study is using

then
i undergo a neurological history and examination by the
studys primary investigator
a neurologist

then
this data is sent off to biogen the maker of the aducanumab drug
to decide if i go further in the study

if declined i will have an amyvid pet scan done privately
and
will move on with my life
looking for a another promising treatment
as
the clocks ticking on me

if i am accepted
i move to a spinal tap for beta amyloid and the tau protein
mri
genetic testing

if i am accepted based on these results
then i get the final test
the amyvid or amyloid pet scan
it will tell if i have the amyloid accumulated in the brain
if positive
im in
and
that means i know i have alzheimers disease for sure
well as sure as one can know without an autopsy of the brain

then
i will start infusions monthly
of a placebo ie water
or
the real deal

i have a 67% chance of getting the real deal
i have a 33% chance of getting the placebo

sorry i want the real deal
but
if i dont after 18 months or so they will switch me over to the real deal
for a total of 4 1/2 years of infusions

i do realize since i have the apoe 4/apoe4 gene
i have an almost 40% chance of having significant side effects
mainly headaches if i get the higher dose of the
drug
luckily few people have had to stop the study from these side effects

if it works
its all worth it

the real deal please


12-17-2016
ALZHEIMERS NEWS-AM I IN
 
this last friday
as my wife she and i were driving up to dallas
to the alzheimers center to begin this journey
hopefully
to get a new treatment for alzheimers disease
that may slow it down or if we are all lucky
stop it in its tracks

i did a lot of contemplating as i drove north
thinking back over the last 6 years
when
we made this same journey to the center
then
i was simply volunteering to be in the normal control group
of the large alzheimers study
alzheimers disease neuroimaging initiative phase 2

i was simply going up
to do my part to further our knowledge of what happens
in alzheimers
and
at the same time start a monitoring process for myself
since
it runs so strongly in our family

friday
as i sat in the same damn chair that i sat in
6 years ago when all this happened
i looked out the window
well the blinds were closed

in my reoccurring dream i have about this
there is a large tree growing up to the 4th floor outside
this window
in my dream it is a sycamore tree
i think because my grandparents one who had dementia
had a huge sycamore tree in their yard
and
i use to climb on it as a kid

all that really is there is just the windows of a building

but as i sat down to take the memory test friday
the same tester was giving the test that gave me the first one
i said you know in my dreams there is a big tree out there
she smiled that sweet smile of hers

now 6 years ago
i was broadsided by failing my memory test
ive done the thing so many times now
i know the parts i cant do very well
interesting is
some of the parts i have gotten better at
some i dont do as well

now
this study is called the aducanumab study
by the company biogen
of all the drugs out there right now
it has the most promising chance of being successful

i have had my eye on this study now for several years
well
i have fought hard to get into it
knowing that this could be my last chance to
plug into one of these new drugs
if i wait too much longer
i may to late for them to do any good
so
i know its now or never for me

now i continue to do all the healthy things i should be
doing
the same ones that all of you who read this should be doing
control blood pressure cholesterol weight
do exercise eat right get sleep avoid stress etc

all those no matter what i will keep doing
oh if you are genetically kin to me you should be aggressively
doing the same
since this drug is really meant for those of you
who have no symptoms but are going to get alzheimers

yes i was a little bit nervous
its like a terminal cancer patient
getting this glimmer of hope
from a new research drug
that will slow down the cancer or cure it

this is what this study means to me

so here we go

we arrived there at 930am and left there at 200pm
with no downtime

first
we met with the screening nurse
who went over the lengthy protocol with us
who went over my medical history with us
who took my vital signs weight etc

then
second
they drew some blood
well a lot of blood
i think i counted 10 vials of blood
its 2/3 of a can of soda
no i didnt faint
but
i need to eat a lot of iron foods for awhile to build
my blood back up
its almost like donating a unit of blood

they are testing cbc chemistries ua all kinds of biomarkers
genetic tests dna and rna studies etc
even saving some for perpetuity
in case its needed for more research some day

i realize i have my blood stored all over the place
across the usa

then
third
since i didnt pass out
i was able to proceed to the next testing
the much dreaded memory testing
it took about an hour
i did parts of the mmse memory test
some components of the moca test
and
a new test thats used specifically for this study

to get in this study
i have to be in the upper part of the mmse
but
must have difficulty with parts of the short term memory part
that correlates with mild cognitive impairment amnestic type
the stage right before alzheimers disease

knowing what i know from taking these things
i passed the mmse and will qualify based on how i felt i did
i had difficulty with the parts of the test that is correlating
with what i have noticed in my day to day life
which is what they are looking for

so far after these three things i feel like i am qualifying
for the study

then
fourth
i underwent answering questions on my memory
by a alzheimers center interviewer
comparing what my wife she has told them
to what i say

first question
do you have memory issues
the answer
yes
granted its subtle probably not recognizable to most
folks who know me

then
fifth
i underwent a lengthy neurological history and examination
by the main investigator at the alzheimers center for
this aducanumab study
he was good at picking out the parts of my history and exam
that correlates with my memory loss

so
at the end of the day
how do i feel about my chances of getting past this step
i feel like i met the criteria
unless something is hidden in the labs somewhere

all this information is sent to the biogen folks
to review
they make the final decision

if they say ok
then
i have a mri of the brain
if i pass that one
then
i have a amyvid pet scan for the bad beta amyloid
the test that is missing from all that i have had done

the one
that i feel will give me my final answer
the one
that will provide me with what i need to plan
the rest of my life

fingers crossed
___________

the finger crossing help since i got accepted in the study in 2016
i got my amyvid pet scan that was positive so i was accepted in the study
i got a total of 7 months of the real drug aducanumab

so when this study is over with if i am reaccepted i will have gotten about 2 1/2 years of the aducanumab infusions

will it help
will it make a difference

only time will tell

there are benefits to you and your family to you participating in these alzheimers research studies

my participation may add time to my being able to be with my family and friends a little longer and to remember it all

it also advances our knowledge of how to treat this awful disease

yes its all worth it

the organicgreen doctor