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Medical Forum / Diseases and Disorders / Alzheimer's / March 2006

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Any positive results in Alzemed trials?

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sheellah@aol.com - 22 Mar 2006 16:44 GMT
My mom is in a clinical trial for Alzemed but I don't think she's
getting the real drug. Does anyone have anyone they care for in this
trial who is showing an improvement in their condition?
Tumbleweed - 22 Mar 2006 19:49 GMT
> My mom is in a clinical trial for Alzemed but I don't think she's
> getting the real drug. Does anyone have anyone they care for in this
> trial who is showing an improvement in their condition?

AFAIK there are no drugs that realistically offer the chance of anyone
improving, the best you can hope for is to stop the decline. I saw some
reports on Flurizan that indicate an improvement, but if you looked at the
actual figures, they were tiny improvements and mostly just an improvement
compared to other drugs, but in all cases still a decline.

Of course, its also possible that your mother is getting the drug, but that
she is either someone for whom its no use, or that she would have been worse
off if she wasnt on it.

I also looked at an Alzemed study
http://www.clinicaltrials.gov/ct/show/NCT00088673
which seemed worrying to me, because it is seemingly measuring the effect of
Alzemed vs a placebo. I thought this kind of thing was unethical, since
there are treatments for Az out there which do slow the disease. At least
the Flurizan trial I saw compared it against other treatments.

If I'm right, that means that people on this trial (which may not be the
same as your mothers) are either getting the drug, which may or may not help
them, or a placebo, which certainly wont, and that is 18 months?? of time
where damage has been done if its the latter, since they could have been
taking something that had a proven slowing effect. Pretty tough on the
people taking the placebo and their carers.

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Tumbleweed

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tumbleweednews at hotmail dot com

Dennis P. Harris - 23 Mar 2006 04:28 GMT
> If I'm right, that means that people on this trial (which may not be the
> same as your mothers) are either getting the drug, which may or may not help
> them, or a placebo, which certainly wont, and that is 18 months?? of time
> where damage has been done if its the latter, since they could have been
> taking something that had a proven slowing effect. Pretty tough on the
> people taking the placebo and their carers.

that's the chance folks take when they participate in correctly
conducted double-blind trials.  and no they are NOT unethical or
illegal (in fact they are required for FDA approvals) but the
participants must give their informed consent.
Tumbleweed - 23 Mar 2006 14:46 GMT
>> If I'm right, that means that people on this trial (which may not be the
>> same as your mothers) are either getting the drug, which may or may not
[quoted text clipped - 8 lines]
> illegal (in fact they are required for FDA approvals) but the
> participants must give their informed consent.

dennis,thats not the case if the study is between the drug, and the drug in
conjunction with another drug which is known to work, for rexample this is
what I understand the Flourizan trial to be. This is also usually (always?)
the case for antibiotiocs, they arent going to test to see if it works by
comparing it vs people who arent getting treatment at all(eg a placebo) but
vs another known antibiotic.

Currently my father is on another trial which is double blind, but the deal
is, that its for 6 months, and at the end of the trial, people who were on
the placebo will get the drug (and those on the drug will continue on it).
Its not a new drug in this case, they are just testing it for efficacy on
people in the later stages (he scored 6 on the MME).

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Alan Holbrook - 23 Mar 2006 18:47 GMT
>>> If I'm right, that means that people on this trial (which may not be
>>> the same as your mothers) are either getting the drug, which may or
[quoted text clipped - 22 lines]
> testing it for efficacy on people in the later stages (he scored 6 on
> the MME).

Tumbleweed,

I believe you're mistaken about the Flourizan trial, at least as it's
being conducted at Boston University.  At BU, according to Dr. Robert
Green, it's a double blind between a placebo and an 800 mg dose, which
is the only dose that appears to have any effect.

BTW, because the Phase II results were rather sketchy, and because my
wife would need to come off of Aricept to participate (she's been on
Aricept fewer than 6 months, a requiremment to join and still continue
the earlier drug), we decided against this trial.

ARH...
Tumbleweed - 23 Mar 2006 20:33 GMT
>>>> If I'm right, that means that people on this trial (which may not be
>>>> the same as your mothers) are either getting the drug, which may or
[quoted text clipped - 36 lines]
>
> ARH...

I cant find it now, but the one I recall was 400, 800 and a placebo which I
think was aricept, or at least  you could be on the trial and be taking
aricept as well.

Anyway, I do recall you posting here earlier, and maybe there will be other
trials or alternatives to take the drug when the 6 month period has elapsed.

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Mary_Gordon@tvo.org - 22 Mar 2006 23:37 GMT
Sheelah, you NEVER participate in a clinical trial without the express
understanding that it may not help you (or your loved one). That is not
the reason for participating - its contributing to the research in the
hopes that down the road, someone will benefit from whatever is
learned.

After all, in a double blind study, you only have a 50-50 chance of
getting whatever drug they are testing, and not even the researchers
dealing with you will know which group you are in - so they won't
introduce bias into their evaluation of the patient's condition. Even
if you did happen to be in the group who got the drug, there is no
promise whatsoever that the new drug will help or hinder - or that you
will even ever know whether she was on the drug.

The truth is, most people who participate in this kind of study accept
that it effectively is too late for them or their loved one - so they
figure they have nothing to lose, and if they can contribute to someone
else being helped at some time in the future, it brings something good
out of something horrible.

Meanwhile you are off other drugs that might help - and you are making
that choice. She's going to go downhill no matter what at this stage of
medical knowledge - the best you can hope for with ANY treatment is a
slower slide.

Mary G.
Evelyn Ruut - 22 Mar 2006 23:56 GMT
> Sheelah, you NEVER participate in a clinical trial without the express
> understanding that it may not help you (or your loved one). That is not
[quoted text clipped - 22 lines]
>
> Mary G.

Sheelah, Mary is right.

If I were you I would pull your mom immediately from this study, and get her
on some serious real meds that you know for sure can help her, that have
already been through all the tests and are proven to work.     After all it
is your mom, and if she has this illness, you should pull out all the stops
and go for whatever you need to do to help her.   To hell with their study.
You need real meds, not just the half a chance possibility that they are
giving her some unproven new drug.

Signature

Best Regards,

Evelyn
(to reply to me personally, remove 'sox')

Alan Meyer - 23 Mar 2006 01:19 GMT
> ...
> Sheelah, Mary is right.
[quoted text clipped - 5 lines]
> her.   To hell with their study. You need real meds, not just the half a chance
> possibility that they are giving her some unproven new drug.

Evelyn,

I'm not sure Mary's posting went quite that far.

The terrible thing about this is that "real meds" don't exist yet.
To my knowledge, the only approved drugs are the
acetylcholinesterase inhibitors.  Those drugs do zero to
halt or even slow the progress of the disease.  For _some_
but not all patients, they help the patient function better in
spite of the disease - but only for a while.

Acetylcholine is a neurotransmitter chemical that transmits
signals between brain cells (neurons).  It is released by a brain
cell, travels a short gap to the next cell, and stimulates that cell
to "fire".

Acetylcholinesterase is an enzyme in the receiving cell that
breaks down the acetylcholine after it has done its work.  Its
purpose in the brain is to keep the same brain cell from
firing over and over again because the signalling chemical
is still present.  The receiving cell is only supposed to fire
once when a signal is received, not repeatedly.

Acetylcholinesterase inhibitors break down the
acetylcholinesterase.  The theory of their use in Alzheimer's
is that the original signal is too weak to stimulate the receiving
cell, or the receiving neuron is too damaged to fire when it
should.  So, by inhibiting the enzyme that breaks down the
signalling chemical, the original signal is, effectively,
strengthened and people's brains function better.

That's the theory.  In practice it may or may not help and
may do harm.  The damage may be such (and eventually
will be such) that reinforcing signals in this way has no
effect on function.  Furthermore, a side effect of failure
to break down acetylcholine may be that the neurons fire
repeatedly when they should not - leading for example to
tremors and to different kinds of mental confusion.  So
these drugs are a mixed blessing and in no case do they
address the real problem.

I believe that the great majority of clinical trials are not going
to save the people who participate in them, but will eventually
save the people who follow them.  They are worth doing.
When I was diagnosed with prostate cancer I was treated
in a clinical trial.  In my case it was a trial of a refinement of
an established treatment (radiation) so the risk was less.
So far (knocking furiously on wood), I think the treatment
was successful and I'm hoping it contributes to successful
treatment for more patients.

There are some side benefits of clinical trials too.  One is
that the doctors doing them tend to be the very best
doctors available, with the most scientific knowledge and
the most time to devote to the patients.   If Sheelah's
experience is like mine, she'll learn more from the clinical
trials doctor, and may get better advice, than she can get
from most clinicians.

   Alan
Bud - 23 Mar 2006 01:55 GMT
To my knowledge, the only approved drugs are the

>acetylcholinesterase inhibitors.  
>
>  

Add the NMDA receptor Memantine which has to do with the
neurotransmitter glutamate and has been shown to slow progression of the
damn disease.
Alan Meyer - 23 Mar 2006 16:01 GMT
> To my knowledge, the only approved drugs are the
>
[quoted text clipped - 3 lines]
> neurotransmitter glutamate and has been shown to slow progression of the
> damn disease.

Right.

I just looked this up.  It appears that Memantine has a similar
physical shape as glutamate, another neurotransmitter, and so
fits into and blocks some of the glutamate receptors.  The theory
here is sort of the opposite of the acetylcholinesterase inhibitors
in that the scientists believe that Alzheimer's brains may have too
much glutamate (as opposed to too little acetylcholine).

But the therapeutic action is similar to the older drugs.  It does
zero to halt, or even slow down, the progression of the disease.
What it does is, in some but not all patients, make it possible
for the brain to function a bit better in spite of the disease.

I'm not opposed to Aricept or Memantine or similar drugs (though
the drug companies rip us off with the prices), but any person who
takes them should be observed to see if:

1) Does it really do any good?
2) Is it continuing to do good? It will eventually stop working.
3) Is it causing any harm/side effects?

Some people do well for a while with these drugs, but caregivers
should understand that using them is like giving aspirin for
pneumonia.  It can be better than nothing but one shouldn't
expect too much.

   Alan
Alan Meyer - 23 Mar 2006 00:36 GMT
> My mom is in a clinical trial for Alzemed but I don't think she's
> getting the real drug. Does anyone have anyone they care for in this
> trial who is showing an improvement in their condition?

You might want to call the company that makes the drug
and ask them.  They can't tell you if your mom is getting
the drug or a placebo, but they might be able to point you
to any published results they already have, and possibly
even to tell you whether the drug is intended to improve
people's condition, stabilize it, or just slow down the losses.

Also, ask your mom's doctor when the trial will be over,
when you will find out if she received the drug or the placebo
and, if she received the placebo, will she be allowed to
get the drug.  If you can't get through to the doctor himself
there may be a nurse or administrative assistant who will
know the answers to these questions (or can get them.)

It appears that the current trial is a phase III trial.  That
usually means that there has already been a phase I trial
to determine safe dosage, and a phase II to determine
whether the drug is really safe and actually does anything
positive.  Phase III is to compare the drug to other
treatments and see if it's better.  If results were completely
negative, the drug wouldn't have gotten this far.

The company may be able to point you to any published
results of the phase II trial, assuming there was one.

If you find out anything useful, please post the information
here for everyone else.

Good luck.

   Alan
 
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