End of the LMTM trial/open label

The results in Lancet were insufficient to convince the sponsor of the trial/open label that I have been involved with, so as of February 23, I will no longer be using LMTM as I have no way of getting the drug anymore,

I had experienced some decline recently; short term memory is much worse, some disorientation. It is not yet debilitating and with the help of my sweetheart and friends, I am doing OK. I am still on Donepezil and Namenda, and am looking for other tau therapy trials. (Why the industry is still pushing amyloid is beyond me or my neurologist's understanding.)

Not good news

I was not part of this study group, but nevertheless, these results are discouraging. Alzheimer's Maverick TauRx Tries To Weave Success From Failed Trial The results of my group (TRx-237-005) will be out 4th quarter this year, but I doubt FDA approval given the failure of this group. In another article, Experimental Tau Protein Drug Tangled Up in Late-Stage Alzheimer's Study Failure, "Our overall opinion is that this was a negative study," said Dean Hartley, director of science initiatives at the Alzheimer's Association. "No difference between LMTX and control on cognitive and behavioral changes falls below FDA's regulatory requirements for approval of an Alzheimer's drug," Hartley added.

I have no idea how long the open-label I am on will continue.

8/4/2016 update: After meeting with my neurologist, we agreed that I would continue with what I have been taking (LMTX open label, namenda, donepezil).

He confirmed stable test results since I began the trial, and also agrees with me in  not trusting the 15% test results from Slovenia as adequate proof to change to  mono-therapy. He and I both hope LMTM will end up being approved, but if not, there are other tau inhibitor therapies in the works.

This really great news....YES!!!!

Mayo Clinic Study of Thousands of Brains Reveals Tau as Driver of Alzheimer’s Disease

Mayo Clinic Study of Thousands of Brains Reveals Tau as Driver of Alzhei...

Onto the open label LMTX...yesyes...

Yesterday, I started on the open label for LMTX, which the article below says had a 90% success rate in stopping the progression in its Phase 2 trials. I just completed the 18-month Phase 3 trial four weeks ago, and yes, while I still have limitations, I (and my neurologist)  can attest that things have not gotten worse.

I am SO very grateful to Professor Claude Wischik, MD, PhD   and everyone at TauRx and the San Francisco Clinical Research Center.

First Evidence of Potential Efficacy of Tau Aggregation Inhibitor Therapy in Alzheimer’s Disease

All is well

A long overdue update, but the good news still holds: no further decline in cognitive function. If this is as bad as it gets, with careful attention to details ("Be in the Now" is not just a spiritual exercise -- it's a way of getting through each day) and with acceptance of my limitations -- I will be very much OK!

The Phase 3 LMTX trial will be going 'open label', meaning I will continue on with the trial drug (and I am quite sure I am on the 'real thing' based on my initial reaction to it many months ago) until it gets approved and fast tracked through the FDA

Gratitude
     gratitude
         gratitude

New Year, renewed hope

I'm greeting this new year with renewed hope that I am really onto something here with the LMTM Phase 3 trial. At my last session, I did not sense any decline in my cognitive tests (still difficulty with remembering lists and any math past 20 is still gone for me, but nothing is worse). The psychologist stated he saw improvement in 'persistent cognition' and the nurse said she has seen really positive results in many of the participants in the trial.

So it's not just my hopeful Irish imagination!

The trial drug is working and my life is before me

TauRx trial -- ain't nothing but the real thing, baby

I am not on a placebo. I am on the real LMTM, because so much is more clear. I still can't do math above 20, still can't read music, still can't multi-task, still get confused, still can't find common words -- but I have an absolute solid sense that WE ARE ONTO SOMETHING HERE!

I know I am not on the placebo because the clarity with which I see/perceive has changed radically in the last six weeks -- as if running the windshield wipers and realizing how dirty the windshield was.

For the first time in 3+ years since the diagnosis, I have not just hope, but a deep inner sense that the rest of my life is before me.

Tau. Wow.

Thank you, God, how can I help?

Yes!!!! I am scheduled to begin the Phase 3 trial of LMTM next week. I'll be on a placebo or the real drug for 18 months, followed be an offer for the real drug. If my hunch about tau (St Francis??) is right....wow....Thank you God, how can I help!

Latest news

Time to get off the river of denial (again) and admit that life is more difficult. The last 4-5 months I have had more moments of complete confusion merging on panic at times, but so far, I can pause when agitated, breathe deeply, slow down, and get myself oriented. But it does mean I need to continue to slow WAAAY down. I also bought a labeling machine, which I will set aside a day to learn how to use and get on it.

I have to be very careful about tidying up. I've never been a neat freak, nor have I been a slob, but my ability to live in a state of 'messiness-light' -- those days are gone. I need clarity, structure, lists, labels -- so I need to find and nurture my inner neat freak (if she exists!)

I'm now on 20 mg Donepezil (generic Aricept) and after a couple of miss-starts, have titrated up slooowwwly to 20 mg Namenda -- both 10mg, twice daily.

Turns out my sense that chewing nicotine gum helps is true according to a recent study, and I'll check with Dr. Starkey re the nasal insulin, as I suspect glucose is an issue.

The latest report from NIH -- reasearch is ridiculously slow (IMHO), but promising

2011-2012 Alzheimer's Disease Progress Report

Groceries and thinking outside the box

Last Tuesday, I bought four bags of groceries and put them in the trunk of my car. The next day, I recall looking in the refrigerator, noticed missing items, felt something was 'not quite right' -- no recollection of the groceries in my trunk. Thursday I noticed my car smelled really strange -- again, no recollection of the groceries in my trunk. Then suddenly Thursday night, an image of me picking up a carton of a dozen organic eggs at Raley's flashes into my mind, and I remember the groceries (which had to be thrown out). It's as if the brian cells responsible for remembering groceries in trunk knew they were dying, sent out SOS signals which were picked up by other brain cells -- "OK, give us a few days to learn the program, but we got you covered!" The good news: My brain can still adapt and I can still create some new reminder notes to put on my dashboard.

Yesterday, my friend Kika gave me a nightlight she had picked up for me in Hawaii. After taking it out and admiring it, while Kika was in the kitchen getting some tea, I put the nightlight back into its purple container (success), then put the purple container into the white box (wrong), and then tried jamming the white box into the brown box on the left (should be the other way around). I kept struggling with it and could NOT figure out what was wrong. Kika returned and I asked her for help and was shocked when she easily put it all back together. The good news: Today, I don't have any problem with this; friends will  help if I ask them; and I have a whole new perspective on 'thinking outside the box.'

President Sarkozy speaks at AAIC (with English translation)

Disappearing acts

Today I discovered:

• I had filed the latest Grapevine in my tax return folder (whaaaaa???),
• put my Blackberry away where I keep phone books (that kinda makes sense), 
• my gardening gloves ended up in the cupboard with the cat food, 
• some cheese ended up in the freezer...
• and I have NO idea where my Yoga DVDs disappeared to...

........BUT........

• I read the Grapevine, 
• the Blackberry is getting charged, 
• I fed the roses, 
• the cheese wasn't that great anyway, 
• I've signed up with a private Yoga teacher,

...and I had a good laugh
...and I was reminded once again that multitasking meganthemegan has left the planet.
Time to sloooooow down.

Thank you, God -- how can I help some other way???? YAAARRRGGGHHH

I had volunteered for the Groundbreaking NIH-supported study expands, seeks new volunteers and felt really good about it. This project gave me a sense of meaning and purpose around the diagnosis. But the folks running it made a mistake.

Actually, they've made a number of mistakes along the way, but up until today, no big deals.


They did not tell me (confirmed by my sister, who has been with me at each appointment) that I was NOT to start any new medications during the initial part of the study. They did not tell me to wait JUST 30 DAYS (which I would have gladly done). Both my sister and I heard them say I must report any changes in medications, but not that I wasn't to change or start any. YAAAAARRGGGHHH!!!

My neurologist (whom I trust) started me on generic Aricept two weeks ago. He believes early, aggressive use of this and Namenda MAY (maybe maybe maybe) slow down the progression.

So I'm out of the study for now. I could begin the study again if I put off taking Namenda, and there's a chance I could start the study again later this year, but my son and I are going to Ireland to celebrate his birthday in October.

So here are the choices:

1. Following my doctor's recommended medication schedule (which may, or may not, slow down the AD progression) and standing in the soft Irish rain with my son celebrating his birthday. Perhaps writing an article "Traveling with Cognitive Impairment -- So What If You End Up On the Wrong Train -- Ireland Will Love You Anyway"
2. Not following my doctor's recommendations due to someone else mistake and participating in a study (for which I am only one of many volunteers) which may not even be relevant one year from now, considering other research that is underway.

...I'm going for what feels like more fun. And ask God to help me find another way to be helpful.

Roses and Julia Child help with technical difficulties.

Limitation is such a neutral word. I had to change the batteries in my car and home alarm fobs. The last time I did this, I probably had the TV on, was engaged in a conversation, with food cooking on the stove -- and I changed the batteries with no problem.

Not so the other day. I got completely lost. Spent 10 minutes trying to open one of the fobs, then realized it was already open. Put the wrong size battery in each fob. Mixed up the new with the dead batteries. Started to feel the tears coming on.

So I went out in the garden.
Had a talk with God, via roses (Julia Child yellow variety) that are still blooming.
Went to Walgreens and bought another set of batteries.
Came home, fixed some chai tea.
Thought about roses and Julia Child.
Took everything veeeerrrryyy slowly.

Both fobs now have new batteries.

I think it was the roses that did it.
Or maybe Julia Child.

St. Francis and Alzheimer's? Yes!

I have this sign on the inside of my front door to help me remember what I might need when I leave the house...and to remind me who is in charge.

The picture is from the labyrinth at the San Damiano Franciscan Retreat Center in Danville, so this sign also reminds me that as my brain becomes a labyrinth, in the center of the maze is always a loving God.










On the outside of my front door is a plaque I bought at the Basilica of St. Francis in Assisi, Italy. It reminds me and my friends "Peace and All Good", the Franciscan greeting.

This is the Tau cross of St. Francis. And here is God's paradox: "Tau" is also the name of a protein in the brain that, when defective, can result in Alzheimer's disease.

So I will wear my Tau cross to keep on the loving side of that paradox, and I bet it will work better than any medication I might end up taking.

..and this is the cherry tree in Assisi I rested under after a hike to the place where St. Francis and his followers went for retreat (and that day was the most beautiful day of my life, other than the day my son was born). I describe how Francis led me on that hike here:
St. Francis leads the way 

It's official...what the neurologist said

The bad news first:

After giving me some more cognitive tests (I drew a clock with time at 11:10 correctly except for the short/long hands -- I resisted the urge to go digital) and neurological tests (I can walk a heal-to-toe straight line -- another blessing of sobriety), the UC Davis Alzheimer's Disease Clinic neurologist stated that my Mild Cognitive Impairment (MCI) is the variety that is the precursor to Alzheimer's and that I may "need more assistance in the near future." The official lingo is Amnestic Multiple Domain MCI.

He recommended I drive only short distances to familiar places. He recommended I put a sign on my stove -- "Use the Timer" -- and use microwave meals whenever possible.

..now the good news:

I will be taking part in the groundbreaking Alzheimer’s Disease Neuroimaging Initiative (ADNI) which is so waaay cool -- not run by Big Pharma, and they will advise all the latest research.

More important -- I absolutely insist upon enjoying life..."we will see where our experience can benefit others" -- and as 1 out of 8 baby-boomers will be joining me on this road, I want to demonstrate how you can lose your mind AND have a good time doing it. WHY NOT?? I want to turn this around from the "long good-bye" to the "long hello to something COMPLETELY different"...where is Monty Python's giant foot when I need it?..oh...here it is:

In truth, my future will probably be a lot harder on my beloveds (if you're reading this, you are one of them) than on me. And I don't want to minimize that this is serious stuff...but no person, place, thing, or illness gets to define who I am, and I am (and will continue to be)

-- meganthemegan.

Spell 'World' Backwards

It took me two tries before I realized the pruning shears wouldn’t unlock the front door;
I panicked when I couldn’t remember my son’s name;
At first I laughed when I started the car and saw I was wearing pajamas and a sweatshirt;
And saying ‘bingo’ when my friends come up with a word I can’t remember is happening so often,
I should probably get over my aversion to the game.

So when the doctor asked me to spell ‘WORLD’ backwards,
I wanted to say “That should be easy given what I’ve been going through.”
But instead, I closed my eyes tight shut, saw the blackboard,
And spelled ‘WORLD’ backwards correctly.

And now I pray he will find something in the five vials of blood
That will give me some option other than coming to a time
When I will not know how to spell ‘WORLD’ backwards.

In the meantime, I learn to cope and
Printed out a sign I can read on my way out the front door:

“Where are you going?
Is God with you?
--Spell ‘WORLD’ backwards--”

(This was written 3 years ago when symptoms first appeared. More on the awful experience I had with doctors at that time BECAUSE I AM A WOMAN in some later blog when I feel like kvetching.)

Maria Shriver - A Woman's Nation Takes on Alzheimer's