Treating Alzheimer's Disease - Leqembi
Aug 17, 2024
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Recently, we have talked about what Alzheimer’s is, different types of Alzheimer’s Disease & what causes Alzheimer’s Disease. After laying that groundwork we can finally discuss and review new medications and treatment solutions for Alzheimer’s.
We
will start this series of blogs reviewing Leqembi (lecanemab).
As
in the last blog, I will remind you, I am not a doctor. I am not a
medical professional. I am a person who can take detailed medical
information, research it, and create content & imagery that will make it
easier for you to understand a specific concept. You should NEVER use my
content to make medical decisions for yourself or your loved one. However, you
can take the content I provide to begin conversations with your
doctor.
What is Leqembi?
Leqembi
is a medication that is used to treat early-stage Alzheimer's
Disease. It is an FDA-approved treatment that targets one aspect of the
underlying biology of the disease. Leqembi works by reducing the amount of
amyloid-beta proteins in the brain, which are a key factor in Alzheimer's
Disease
Leqembi
is administered as an intravenous (IV) infusion every two weeks at an infusion
center. Each infusion usually lasts about an hour. Leqembi is
approved for people with mild Alzheimer's disease, which means they have some
memory and thinking problems, but their symptoms are not severe. It can
also be used to treat mild cognitive impairment (MCI) and mild dementia due to
Alzheimer's disease.
It
is important to note that Leqembi is not a cure. I will repeat it to be
clear. Leqembi is NOT a cure for Alzheimer’s Disease. Alzheimer’s Disease
is triggered by multiple conditions such as diabetes, genetics, toxic
environmental exposure, and inflammation. Leqembi was designed to slow
Alzheimer's progression by identifying and attacking beta-amyloid proteins in
the brain.
This
is significant because beta amyloids are one of the hallmarks of Alzheimer’s.
These proteins clump together to form plaques that destroy neurons. Neurons are
the cells that form the brain’s communication system. Leqembi is a
monoclonal antibody that binds to these plaques and breaks them apart.
What is a monoclonal antibody?
Monoclonal
antibodies (mAbs) are laboratory-made proteins that are a type of targeted
therapy used to treat a variety of diseases, including some types of cancer and
COVID-19. Monoclonal antibodies are highly specific because they are derived
from a single clone of cells and are engineered to closely reflect the
structure of naturally produced human proteins. This means that the body
handles them similarly. The body does not metabolize monoclonal antibodies like
it would a synthetic medication.
mAbs
are created in a lab from living sources that produce antibodies, such as
human B cells. Or immunized animals. The first step in the process
is to express a purified antigen, which is often a critical step. The mAbs
are then produced by identical clones of B lymphocytes against a specific
antigen.
How are monoclonal antibodies produced?
The
traditional monoclonal antibody production process usually starts with a
generation of mAb-producing cells (i.e. hybridomas) by fusing myeloma
cells with desired antibody-producing splenocytes (e.g. B cells). These B cells
are typically sourced from humans or animals, usually rodents.
Human
mAbs can be used to target and neutralize specific proteins that induce an
immune response, such as those associated with inflammation in psoriasis and
other autoimmune disorders. Leqembi is an example of a human mAb used to
treat Alzheimer's disease.
Advantages
of using mAbs:
·
Precision - mAbs are more precise than other treatments, which can improve
effectiveness and reduce side effects. For example, monoclonal antibody
therapy can target cancer without damaging healthy cells.
·
Safety - mAbs are safer and less toxic than chemotherapy drugs, which can
improve patient survival and well-being.
·
Quality - mAbs quality is consistent across production batches, which is
important for both therapy and diagnostics.
·
Quantity - mAbs can be produced in large quantities.
·
Other advantages - mAbs also have fewer off-target adverse effects, fewer
drug-drug interactions, and higher specificity.
Disadvantages of mAbs in an overview
- long lead times
for traditional mAbs manufacture methods (hybridoma)
- relatively high
cost of goods
- laborious
process, hybridoma cell generation has low yields
- selectivity is
hard to achieve for peptide targets with few amino acid residues
- contamination
and risk of loss for hybridoma cultures
- limited uses due
to the mode of action
It
is not uncommon to have an infusion reaction when taking mAbs. It is like
an allergic reaction. Symptoms can include fever, chills, weakness,
headache, nausea, vomiting, diarrhea, low blood pressure, and rashes, and are
more common when the drug is first given. This is your body’s response to
taking a biological medication and will usually subside as you get used to it.
Who can take Leqembi?
Now
that we understand what Leqembi is and how it works. Who can take
Leqembi?
In
theory, anyone experiencing mild cognitive impairment or the early stages of
Alzheimer’s Disease. However, to qualify for treatment with Leqembi,
patients must meet the same criteria used in the clinical trials that led to
its approval:
·
Be between the ages of 50 and 90
·
Have a confirmed presence of beta-amyloid plaques in the brain
·
Have mild cognitive impairment (MCI) or mild dementia due to Alzheimer's
disease
·
Have a body mass index (BMI) between 17 and 35
Potential
patients must undergo diagnostic testing to confirm the presence of
beta-amyloids before starting treatment, which is usually done with a PET scan
and/or a spinal tap. Leqembi has not been tested on people with more
advanced Alzheimer's or those without symptoms, so they do not qualify for
treatment.
Side Effects of Leqembi
There
are potential side effects with every medication. No one should be
surprised that there are side effects with Leqembi. The following
information was taken word for word from Eisai and Biogen, the manufacturers
and distributors of Leqembi:
LEQEMBI
can cause serious side effects, including:
·
ARIA (amyloid-related imaging abnormalities). There are usually no signs of
ARIA. In rare cases, it can lead to serious complications
·
ARIA can show up as swelling in parts of the brain or small spots of bleeding
·
Larger areas of bleeding in the brain may occur, but this is uncommon
·
ARIA usually goes away over time
·
Most people with ARIA don’t have any symptoms. However, some people
may notice:
–headache
–confusion
that gets worse
–dizziness
–vision
problems
–nausea
–problems
walking
–seizures
·
Some people have a gene called ApoE4 that may increase the risk of ARIA. Talk
to your healthcare provider about testing to see if you
have this gene
·
Some medicines can increase the risk of larger areas of bleeding in the brain
for people taking LEQEMBI. Talk to your healthcare provider to see if any of
the medicines you’re taking increase this risk
·
Your healthcare provider will check for ARIA with MRI (magnetic resonance
imaging) scans before you start LEQEMBI and during treatment
I
want to be careful to not over-dramatize these side effects. As I have
said in previous Blogs, I am a study buddy for a loved one participating in a
research program with (BAN2401) Leqembi. My loved one has experienced
Aria-E and Aria-H.
The
Aria-H experience was by far the most dramatic of the two. It started
when my loved one woke up from a deep sleep after feeling and hearing what she
described as an explosion in her brain. She said it felt like she had
been hit by a brick. She sat up and placed her hand on top of her head as
you would when something just hit you. When she removed her hand to look
at it, she fully expected to see blood on her hand. But there was no
blood. She got up out of bed, went to the bathroom, made a note in her journal,
laid back down, and went back to sleep.
There
are some important things to point out here:
She
said she felt like she was hit with a brick. However, there are no pain
receptors in the brain. And later she would say that it felt like being hit by
a brick but without pain. I say this to be clear that as traumatizing as
it was, there was no pain.
She
calls it an explosion in her head. She is confident that she heard the
sudden micro hemorrhage take place. And that she heard the blood flow.
I am 100% confident that she did. My loved one is not one to
over-dramatize facts.
But
how big was this hemorrhage? To be classified as a micro hemorrhage it
must be smaller than 5 millimeters in diameter. How big is that?
The size of her micro hemorrhage was between the size of the tip of a pencil
lead and half the diameter of the eraser tip. VERY small.
Despite
the potential of brain swelling and another brain bleed, I stand behind her
choice to continue to take Leqembi. Knowing that any day, I might get a
phone call with her telling me it happened again. Because without this medication,
I believe her cognitive decline will become significant. We are not
giving up on her and her desire to be a volunteer for Alzheimer’s research.
How do I get started?
OK,
so you heard all about the scary potential of experiencing a brain bleed and
potential brain swelling. You understand that by taking no action, you
are guaranteeing continued cognitive decline. And you want to start the
evaluation process to see if you are a good candidate for Leqembi
treatment. How do you get started? There are 2 options:
Schedule
an appointment with your neurologist to learn more.
- If you do not
have a neurologist or if you want to be sure you are working with a
Leqembi-friendly neurologist, send me an email
(teri@protonmail.com). I will need to know where you are
located. With that information, I will get back to you with a couple
of options.
- This is a great
option if you have insurance that will pay for all or part of the testing
and medication.
Schedule
an appointment with an Alzheimer’s Research facility.
- Research doctors
have the same qualifications as neurologists in private
practice. However, most research studies do not guarantee that
you will receive the medication in the first round. You may receive
a placebo first and the study medication later.
- Research studies
often offer protocols that are not available to the public yet.
- If you do not
have insurance, this is a great solution to get the medication you need to
slow cognitive decline.
- Research studies
offer protocols at no charge. You will pay nothing.
How much does it cost?
The
answer to that question is difficult to answer because there are so many
factors to be considered. The Japanese drugmaker Eisai set the list price for
Leqembi, at $26,500 per year in the United States. However, the
actual cost for patients will vary depending on their insurance
coverage. For example, Medicare beneficiaries are responsible for 20% of
the cost after meeting their Part B deductible, which means the out-of-pocket
cost for Medicare enrollees is $5,300 per year. Other factors that may
affect the cost include Medicare supplemental or other secondary insurance,
Medicare Advantage plans, and Medicaid.
In
addition to the cost of the drug itself, there are also associated expenses for
diagnosing and monitoring patients, such as PET scans, MRI scans, and clinical
visits.
Is it worth it?
It
is for my loved one. Despite experiencing brain swelling and a brain
bleed, she won’t stop as long as it is available.
I
know that if I am diagnosed with mild cognitive impairment or Alzheimer’s
disease, I would take it or a similar mAB as a multi-step treatment
protocol. I would work with an Alzheimer’s Disease researcher to be sure
every bit of information is captured.
Is
it worth it to you? Only you can decide.
- To view the original version of this article visit alzheimerssurvivor.com/blogs/what-is-an-alzheimers-survivor/leqembi
- Seniors Blue Book was not involved in the creation of this content.
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