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

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Opinions on Joing This Clinical Trial?

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Alan Holbrook - 18 Feb 2006 11:03 GMT
My wife, 58 years old, was diagnosed in December with early onset AD.  Her
neurologist immediately put her on 5mg daily of Aricept and then recently
increased the dose to 10mg daily.  Aside from a frighteningly poor short
term memory, she is only very minorly impaired at this point, still living
at home and being there alone during the day while I'm at work and driving
to run small errands to places where she's comfortable, etc.

We've just been invited to participate in the Flurizan Pase III trials.  
However, in order to qualify, she has to be stable on Aricept for 6 months
or be off it entirely for 30 days.  For us, considering the timing of the
trials, coming off the Aricept would be the only option.  So I'd be
interested in hearing the opinions of people in this group: considering the
effectivity of Aricept, the fact that people who go off it apparently never
regain the ground they lose, the double blind nature of the study, etc.,
what would you do in our situation?

TIA,
ARH...
Dennis P. Harris - 19 Feb 2006 01:40 GMT
> We've just been invited to participate in the Flurizan Pase III trials.  
> However, in order to qualify, she has to be stable on Aricept for 6 months
[quoted text clipped - 4 lines]
> regain the ground they lose, the double blind nature of the study, etc.,
> what would you do in our situation?

If it were my spouse I would not take a 50% chance that she would
be taking a placebo --- in other words, getting no medication at
all.

If I were in your situation, I would continue with the Aricept
and add Memantine, stabilize for 6 months, and see if they still
need study subjects.

From reading the info at the Flurizan web site, it appears that
the time to start taking it is *before* symptoms become apparent.
Tumbleweed - 19 Feb 2006 08:59 GMT
>> We've just been invited to participate in the Flurizan Pase III trials.
>> However, in order to qualify, she has to be stable on Aricept for 6
[quoted text clipped - 18 lines]
> From reading the info at the Flurizan web site, it appears that
> the time to start taking it is *before* symptoms become apparent.

I've just been looking at the results of the phase 2 trial;
http://www.myriad.com/downloads/IPA_Stockholm_9-22-05.pdf

Patients were divided into three groups;placebo, 400mg and 800mg.
To my eye, it looks as if only the 800Mg had an effect (and certainly that
effect looked good).

So, to the OP, it looks like it would only be a 33% chance of getting an
effective dose, and 66% chance it wont be as good as aricept. So if i was in
that position I'd stay with the aricept and hope that in 6 months time there
was another trial, or that the drug was available anyway.

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Tumbleweed - 19 Feb 2006 08:42 GMT
> My wife, 58 years old, was diagnosed in December with early onset AD.  Her
> neurologist immediately put her on 5mg daily of Aricept and then recently
[quoted text clipped - 16 lines]
> TIA,
> ARH...

Thats a tough one. But unless Flurizan has a similar immediate effect
similar to aricept, chances are you'll see a big drop off. My father moved
from aricept to memantine (for a trial) and the memantine almost certainly
didnt make up for the aricept in retrospect . In my case, though it was a
double blind trial, I could geta tablet analysed and find out that he wasnt
on the placebo, but even then I:m not sure it was worth it. have you checked
out what effects Flurizan has, I hadnt herad of it before these postinsg
here but if its goingt o phase 3 trials it must ahve had some promising
results.

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Alan Holbrook - 19 Feb 2006 11:50 GMT
>> My wife, 58 years old, was diagnosed in December with early onset AD.
>>  Her neurologist immediately put her on 5mg daily of Aricept and then
[quoted text clipped - 27 lines]
> herad of it before these postinsg here but if its goingt o phase 3
> trials it must ahve had some promising results.

Thanks to both of you who've answered.  Your thoughts are echoing mine
almost exactly.  It really doesn't seem worth the risk.  By the way, the
results of the Phase II trials (I can't remember the web site where I
got this) were characterized as either ineffective or inconclusive with
standard statistical methods, but the developer saw some trends when
analyzing the results from a different approach, so they went ahead with
the Phase III.  Not exactly something I'm anxious to risk my wife over.
Mary_Gordon@tvo.org - 19 Feb 2006 16:01 GMT
Hi Alan - personally, I think the only way you can go into any clinical
trial is with the attitude that you are contributing to future
knowledge, and perhaps improving treatments...for other patients.

If its a proper trial, not only do you have no way of knowing if the
medication will help or hinder, you don't even know your loved one will
get that medication (vs. a sugar pill).  And given that you can't
continue to give her other medications that you do know help her, you
exchange that small positive for a complete unknown. In other words,
its not even a 50-50 odds that it will do something wonderful for her,
since the drug itself is untried.

At this stage, when both of you have the most to lose, and the most you
want to preserve, is probably not the time to risk what you have for
what could be nothing gained and so much lost.

By the by, she really shouldn't be driving. You may only be seeing the
poor short term memory issues, but as you know, AD affects a number of
other important skills very early in the game. It may not be obvious to
you yet, but she is likely also impaired in judgement, reaction time,
emotional control, and even depth perception - all crucial skills for
safe driving.

Mary
Tumbleweed - 19 Feb 2006 17:04 GMT
> Hi Alan - personally, I think the only way you can go into any clinical
> trial is with the attitude that you are contributing to future
[quoted text clipped - 20 lines]
>
> Mary

She is driving? No, I think you read the OPs message incorrectly.

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Mary_Gordon@tvo.org - 19 Feb 2006 22:45 GMT
Tumbleweed, the OPwrote: Aside from a frighteningly poor short
term memory, she is only very minorly impaired at this point, still
living
at home and being there alone during the day while I'm at work and
driving
to run small errands to places where she's comfortable.

I took this to mean she's alone at home during the day while the hubbie
is at work, and she's doing routine little errands driving locally in
familiar places. ...No??...

Mary G.
Tumbleweed - 20 Feb 2006 07:46 GMT
> Tumbleweed, the OPwrote: Aside from a frighteningly poor short
> term memory, she is only very minorly impaired at this point, still
[quoted text clipped - 8 lines]
>
> Mary G.

At first I thought it was him running the errands but reading it again I
think maybe you're right. Thats **very** worrying if so, anyone with a score
that low is without doubt a danger to herself and more importantly others.

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Alan Holbrook - 20 Feb 2006 11:45 GMT
>> Tumbleweed, the OPwrote: Aside from a frighteningly poor short
>> term memory, she is only very minorly impaired at this point, still
[quoted text clipped - 13 lines]
> a score that low is without doubt a danger to herself and more
> importantly others.

H'mmmmm.  I don't want to take the original thread too far away into
something else that I'm sure has been beaten to death before I found
this NG, but the two of you are touching on something that is, of
course, a major concern of ours.  How do you make the decision not to
drive?  Our neurologist (and if I gave you the guys name and you did a
Google on him, you'd be VERY impressed...) says driving to routine
errands in places she knows is fine.  Her PCP says the same.  I have
been in the passenger seat a couple of times recently while she drove,
and I had no concerns with her performance.  How do you make that
decision, aside from "Ooops, shoulda' stopped just before this here
accident!!!"?

BTW, Tumbleweed, you said "with a score that low" she shouldn't be
driving.  What score were you referring to?

ARH...
Mary_Gordon@tvo.org - 20 Feb 2006 12:23 GMT
I think Tumbleweed was thinking your wife was the woman with the MMSE
score of 21, but I believe thats another poster.

Anyway, back to the driving issue.

If she is impaired enough for it to have been diagnosed, and for the
short term memory issues to be quite obvious, she is impaired in other
areas - whether or not those impairments are obvious in social
situations or not. I've often related the story of my MIL's tests -
they sent her to a psychometrist for a day's worth of testing - very
similar to what they would put a child through looking for learning
disabilities. It covered reaction time, reasoning, judgement, depth
perception, memory etc. etc. My husband sat with her during the
testing. At the time, had you met her, you would not have thought there
was much wrong with her. However, the test results were quite shocking
to us, as the impairment was so much more extensive than we would ever,
ever had guessed.

Even if your wife has had this extensive cognitive testing to determine
her precise degree and areas of impairment, its a moving target. She
might be fine in January but missing a key ability by February.

In most jurisdictions, doctors have a legal responsibility to report
any patient who is driving with a medical condition that might impact
their ability to do so safely. The usual drill is to report them to the
licensing authority, who will then send out a letter saying they have
to have an assessment or a drivers test by a specific date, or their
license will be suspended. You don't say where you live - do a google
on the subject and see.

In some places, there are people who make their living doing in car
driving assessments for the elderly. Here in Ontario, just an
assessment is not enough - the person has to actually redo both the
written and driving portions of their drivers test. Faced with the
learners manual full of speed limits, signage etc. my MIL threw in the
towel. She knew she wouldn't be able to do the written portion - and
I'm sure the driving portion would have been failed as well.

I personally think its irresponsible for her neurologist to say its
okay for her to drive - never mind that he's putting himself in a
position of liability should she have an accident. She has a
progressive, incurable brain disease - he's not a trained driving
expert sitting in the car watching her to see what she's doing on a
daily basis.

Most accidents happen very close to home - here are some figures from
an insurance company. Being close to home may keep her from getting
lost (at this stage,  anyway), but won't stop her from panicking or
making an error in a situation that requires fast reactions and good
judgement. Its not just her you have to protect - its other people on
the road and the sidewalks.

1 mile or less     23 percent
2 to 5 miles     29 percent
6 to 10 miles     17 percent
11 to 15 miles     8 percent
16 to 20 miles     6 percent
More than 20 miles     17 percent

My suggestion would be to find out what the rules are where you are,
and as a bare minimum, have her driving assessed by a professional -
and start planning for the end of driving - perhaps get a standing
account with a local cab company to come drive her to whereever she
wants to go.

Mary G.
Tumbleweed - 20 Feb 2006 15:26 GMT
> H'mmmmm.  I don't want to take the original thread too far away into
> something else that I'm sure has been beaten to death before I found
[quoted text clipped - 7 lines]
> decision, aside from "Ooops, shoulda' stopped just before this here
> accident!!!"?

I'd say by making the simple decision "no one with Az should be driving,
full stop".
If she is just doing local errands, then its very likely anyway that getting
rid of the car will easily release enough money to pay for taxis and still
have some to spare.

At some point, you are going to decide she isnt safe to drive. That point
is, most likely, to be after an 'incident'. That might be innocent, maybe
she just gets lost, or goes a strange way, but it might be a near miss,  or
it might be after she injures or kills someone. You are gambling it wont be
the latter. WIth her life, and more importantly, other peoples lives.

If you are in the car with her , you''ll be giving her subtle hints without
even noticing it. 'turn here', 'look out for the kid on the bike', etc.
Whats her driving like when there is no one else there? You are likely only
going to find out when its gotten really bad because something bad happened.

> BTW, Tumbleweed, you said "with a score that low" she shouldn't be
> driving.  What score were you referring to?

I thought she was the lady with a score of 21, got my posts mixed up.

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Ruth - 21 Feb 2006 02:58 GMT
> H'mmmmm.  I don't want to take the original thread too far away into
> something else that I'm sure has been beaten to death before I found
> this NG, but the two of you are touching on something that is, of
> course, a major concern of ours.  How do you make the decision not to
> drive?
<snip>

Two of the large rehab facilities in our area - upstate New York - offer
driving evaluations.  My husband's was ordered by his primary care doctor
and paid for by his insurance.  The results were conclusive - do not drive.
Having a neutral party decide this issue kept me from being  "the bad guy".
Ruth
Dennis P. Harris - 21 Feb 2006 04:51 GMT
> How do you make the decision not to
> drive?  Our neurologist (and if I gave you the guys name and you did a
[quoted text clipped - 4 lines]
> decision, aside from "Ooops, shoulda' stopped just before this here
> accident!!!"?

you call your DMV and tell them she has been diagnosed, and in
most states, they will require that she take and pass a driving
test.  or in states where a diagnosis means an automatic
cancellation of her license, they will cancel her license and
send her a notice.  in some states doctors *are required* to
report an alzheimer's diagnosis to the DMV.

i personally would not get in the passenger seat with someone
driving who was diagnosed, and i would want the driver tested as
soon as possible after diagnosis and every few months thereafter.

as evelyn said, part of the problem is the unpredictablility ---
abilities can disappear suddenly, often when the AD person is
under stress.  that's when they hit the accelerator instead of
the brake pedal or turn the wrong way down a one way street, or
enter the wrong lane on the freeway.

for the safety of everyone on the road, please check with your
DMV on state law, and then have her tested if the law won't
immediately stop her driving.
Karen - 22 Feb 2006 02:19 GMT
----snip----
Our neurologist (and if I gave you the guys name and you did a
> Google on him, you'd be VERY impressed...) says driving to routine
> errands in places she knows is fine.  Her PCP says the same.  I have
> been in the passenger seat a couple of times recently while she drove,
> and I had no concerns with her performance.  ----snip----

Alan, it may seem like a familiar area would be safe, but I was with my MIL
when she blew past an elementary school at 50+ on a neighborhood street.
When the school zone was pointed out, her comment was "There didn't used to
be a school there."  However familiar, neighborhoods aren't static, they
change.

OTOH, I've actually seen a few articles saying it's not an automatic
decision.  I can only think that's due to better drugs and earlier
diagnosis.  Her doc is probably the best one to make that call.  But I'd
want to know how frequently the doc re-evaluated.  It's not something you'd
want to drop off their radar screen.

Karen
------------
http://www.cnn.com/HEALTH/library/HO/00046.html
The transition: Gradual or abrupt

Some people believe that anyone who has been diagnosed with Alzheimer's
should not drive. Others say that people in the early stages of the disease
should have their driving skills evaluated individually. People who can
still pay attention to the road and judge speed and distance with reasonable
accuracy may be able to give up driving in stages. Such people may continue
to drive on short daytime trips in familiar surroundings.

------------

http://alzheimers.about.com/cs/diagnosisissues/a/Driving.htm
People with early stage, very mild Alzheimer's disease, can and do drive
safely, however when the disease progresses to the moderate or severe
stages, then driving must stop.

------------
http://www.alzgreatplains.org/alzheimers/day_to_day.html?day_to_day_item=1087&db
_item=listitem

A diagnosis of Alzheimer's disease does not mean the person has lost all
ability to drive. Caregivers should evaluate the person regularly to
determine if it is safe for him or her to drive.
Alan Holbrook - 22 Feb 2006 11:26 GMT
> ----snip----
> Our neurologist (and if I gave you the guys name and you did a
[quoted text clipped - 16 lines]
>
> Karen

Karen,

With all due respect to those who've already replied, I think this is a
more balanced and logical approach to the issue.  Nobody wants a loved
one to injure themselves or to cause injury to others, but there is
plenty of opportunity to do that in many parts of our daily lives, AD
aside.

Another poster asked where we were from.  We're located in the US in
Massachusetts.  Massachusetts is a "driver responsibility" state,
meaning it's up to us to be evaluated.  I've discussed this with my wife
and we are making an appointment with a state recommended facility to
have her driving ability checked out.  We'll go with their dicision.

Thanks,
Alan
Mary_Gordon@tvo.org - 22 Feb 2006 11:42 GMT
Here is a study you might be interested in participating in, being done
in your state.

http://www.alzmass.org/research/listings.asp?id=103&flag=approved

Incidentally, if you are having an assessment done, keep in mind, its
only valid for a few months, and will have to be repeated every 4
months or so to have any meaning.

M.
Karen - 23 Feb 2006 03:30 GMT
> Karen,
>
[quoted text clipped - 12 lines]
> Thanks,
> Alan

You are in a different situation than we were with my MIl.  We later found
out that she had received a diagnosis of ALZ 18 mos. earlier and didn't
remember ever seeing that doc.  She was living in a small town many hours
from any family member and no one was around to witness her decline except
her friends (and they thought it was "normal").  She seemed normal when she
visited our town 4 times a year (she traveled with a friend) but there are
different life skills required to travel versus keeping up a house and car.
By the time discovered the true situation, a more drastic reaction was
necessary.  Your wife has you, my MIL had no one in town but wouldn't
consider moving.

An independant evaluation sounds logical.  If you can get your insurance
agent to discuss the situation "off the record" you may want to ask them if
the test would protect you from additional liability in case she is in an
accident.  99% of the time, driving is routine.  It's that 1% you need to be
prepared for.

I have to say given the choice between shraring the road with a person with
diagnosed ALZ or sharing the road with a driver on a cell phone, I think I'd
have to choose the person with ALZ -- at least they are trying to drive
well.  (sorry, bad experience on the drive home tonight -- choice between
being rear-ended by a clueless speeding pickup on his cell phone and a crazy
person running across 5 lanes of traffic in the dark)  You never know what's
going to happen on the road so I understand the cautious approach with
dementia/ALZ.  I wish I could understand people that _choose_ to not pay
attention.

Karen
Dennis P. Harris - 23 Feb 2006 07:28 GMT
> I've discussed this with my wife
> and we are making an appointment with a state recommended facility to
> have her driving ability checked out.  We'll go with their dicision.

A wise move.
 
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