alzheimers news-explaining clinical trials

ALZHEIMERS NEWS-EXPLAINING CLINCIAL TRIALS

if you are on a medication or if you have a medical device in your body like an hip replacement or knee replacement or heart valve etc then these things have all gone through clinical trials

patients have volunteered to be in these studies which enable them to get care months to years before others can access it

i have been in two clinical trials
one was the adni 2 study where diagnostic testing was evaluated in the diagnosis of alzheimers
the tests were your usual blood tests genetic alzheimers tests ekg mri of the brain amyloid pet scans of the brain various memory tests and neuropsychological tests spinal fluid analysis for amyloid and tau neurological exams
these were done serially over 5 years
this study provided the information thats used now to evaluate folks for memory loss and for testing thats used in all alzheimers drug treatment trials
its the most important alzheimers study ever done

from this study i found out i had mci that was due to alzheimers and that i carry the apoe 4 gene

i am now in biogens embark aduhelm or aducanumab study
its an extension of the phase 3 study of aduhelm for early alzheimers
i have had 14 infusions of aduhelm and 18 infusions of placebo
it will be the study along with a new phase 4 study that will give final proof if aduhelm really works
one year of this drug removes most of the measurable amyloid plaques on amyloid pet scans
i have been able to access this drug months before others will be able to

if it works to slow down this disease then i will have gained time to be with my family and know i was with them

here is a good article on clinical trials that explains what they are and how it works

you can also find clinical trials on any disease or medication at
clinicaltrials.gov 

just type in the disease and or a drug and all the clinical trials for them will show up


most clinical trials are blinded
that means the researcher and the participant doesnt know who is on the real drug or placebo
commonly at the end of the study they let you know if you are on the placebo or not
at the end of my previous aduhelm study they let me know i was on the placebo originally then at 18 months was switched over to the real drug aduhelm or aducanumab

phase 1 is usually on a small number of folks
its looking for safety side effects and dosage

with aduhelm or aducanumab they studied around 100 folks 
at the end of the study they found that those on the higher doses had eliminated most if not all of the amyloid plaque on the amyloid pet scans
placebo patients had no change on scans
memory testing showed some slight improvement on higher dose patients and no change on placebo patients

phase 2 is done on more folks and is used to determine how effective it is

since the aduhelm or aducanumab phase 1 results were so good and alzheimers was such a terrible disease the fda allowed biogen to skip phase 2 studies
a step skip that should not happen
you usually cant rush science

phase 3 is done on an even larger group of folks looking closer at effectiveness and safety and dosage 

this is where the fda and biogen screwed up
the studies werent completed as originally planned
biogen probably tried to influence the fda and researchers and politicians and the alzheimers association to get its approval
it was approved without those 3 phases being doing like they should have been done

thats what has gotten us in this mess with aduhelm or aducanumab being approved before it was adequately studied
we were about 3-5 years away from that point being reached

you cant rush science
you canrt play politics with science
they biogen is paying the price as are also those of us and our families who have this diagnosis

as i said in my interviews something smells about all of this 

phase 4 is commonly required by the fda after a drug is approved to better assess the drugs long term safety and effectiveness

biogen is being required to do a long term phase 4 study on aduhelm or aducanumab that may be somewhere between 5-10 years
if it fails in this phase 4 study it will be removed permanently from the market

should it have been approved
yes with restrictions 
it the approval has opened the door for alzheimers drug treatments coming down the pike that will arrive much sooner now for approval

if it works those few months or years of early approval for those who took it will make it all worthwhile

in summary 
biogen didnt follow the rules the scientific rules 
and
they and us in the alzheimers world may pay the price

now for me im glad i have access to it 
it gives me hope
there is not another medicine available right now
granted there are others that look promising but they are following the rules and may be years away from approval

so for me and many others aduhelm or aducanumab is the only one available

my guess is that
aduhelm or aducanumab really does work
it definitely no doubt about it removes all the measurable amyloid plaque in the brain after a year of infusions
the question is 
will removing that plaque make a difference
has the train already left the station
the tau tangles and inflammation that occurs after amyloid plaques formed has already started up and is progressing
eg i have had a tau protein pet scan of the brain so researchers know how far down the track it has gone for me
sorry you dont get to see the results
is part of the deal

amyloid accumulates years before tau tangles and inflammation start and longer before memory issues start
if you stop the amyloid from accumulating how long before removing it that it really affects memory decline from getting worse
maybe its 2 years or maybe its 5 years or maybe its 10 years or longer

it may be years before i know what effect aduhelm or aducanumab infusions are having on the progression of this disease

its like damming up a river 
the water keeps on flowing downstream but eventually it slows a lot or stops altogether
thats what im hoping
that aduhelm or aducanumab is like a river dam 

today i go to ucla for my 15th aduhelm or aducanumab infusion 
it will be the second time i have gotten the  high dose of 10 mg/kg of the drug
so far i have had no headache in over two weeks
my last mri two weeks ago was negative for a microbleed or aria
i will have another one in two weeks

do consider a clinical trial for your disease
without folks doing these none of your drugs would be available to you

the organicgreen doctor