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wright

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Hey guys

I was sent the lithium study by a fellow ALS forum member (Mark) and it certainly appears to be very well done. It was a double-blind study (with the exception of one physician who needed to know who was getting lithium to adjust levels if needed . . . but that physician did not evaluate any of the data). As the initial rumors had it, lithium significantly slowed the progression of the disease. There were a number of parameters used to asses progression: ALSFRS-R scale, Norris scale and forced vital capacity to measure lung function. There were 16 test subjects who took lithium (25% were bulbar . . . that is . . . 4 of the 16) and 22 controls who took a placebo (29% were bulbar . . . that is . . . 7 of the 22). All of the lithium-taking PALS survived and stayed relatively stable over a period of 15 months. There was definite decline in health in the control group, along with about 30% who did not survive (they didn't indicate if they were bulbar or limb-onset).
This clinical study was more or less rushed to be started because of the promising data they had gathered previously in an animal mouse model and in cell culture. They showed that lithium was able to actually cause an increase in a certain type of cell (Renshaw cells) in the spinal cord (these cells are not motor neurons) thought to be involved in the disease process of ALS. They also showed how lithium "stabilizes" certain structures of motor neurons that help them survive, showed that lithium causes the motor neurons to get rid of structures that cause damage, and that lithium promotes a number of other processes that keeps motor neurons from dying.
The only draw-back in the study is the small number of participants. Sometimes when a study is this small, it doesn't always give a true reading. However, from what I understand, they are going to have a much bigger trial, and I'm sure there will be many more studies to follow this one in clinics around the world and I'm sure those studies will be large ones.
Bottom line: it certainly looks promising to me. Again, the study was well done, so I think we should all be hopeful. As I've seen on here, there are a number of you already taking lithium, so keep us posted as to your progress . . . or should I say . . . slowing of progression. :mrgreen:
 

ZenArcher

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This is all I have to say regarding the study size:

The study protocol was approved by the Neuromed IRCCS Ethical Committee, and all subjects provided written informed consent. Initial statistical analysis determined that at least 40 subjects were needed to determine, with a 95% confidence interval, a survival increase >6 months.
The present study was performed on 44 patients (20 male and 24 female).
 

wright

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In the "study design and patients" the study indicates that they have 16 individuals for the experimental group and 28 individuals for the control group. However, further down in that same section, it says that there were 22 individuals for the control group. I'm not sure what to make of that. I'm amazed that the reviewers of the manuscript didn't catch that.
 

brooksea

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Didn't some of the control group die, not only from ALS, but from heart attack, etc...?
 

ZenArcher

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The study states that 29% of the control group died within the 15 month test meaning 8 people while all those on lithium survived. There have been reports elsewhere that two of the test group died prior to the two year mark one from a heart attack and one from ALS related causes due to advanced bulbar symptoms at trial onset but neither of these are within the scope of this paper.
 

dona jean

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lithium study

there are quite a few folks that are already taking lithium, of coarse they just started durning january, so no one really has any feed back yet. i go to my als clinic at univ. of va. next wednesday and i am going to discuss taking the lithium with the dr.s there.
dona
 
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northerngirl

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Have not seen the side effects from taking lithium, but on another forum some of thier doctors are saying what the heck, what do we got to lose. we know the drug, it has been around for a long time. And some doctors say no way it has not been approved. I have my fingers crossed and my prayers sent that this will open a little window.
 

stevef

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promising

This does look promising. What is it going to take the US based research sites to start an experiment. It sounded like on the MDA?ALS site they mite be looking into it. Something need to be done to get the ball rolling for a bigger study especiall int he US and Canada
 

Al

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Don't know if I'm supposed to say yet but a large Canadian hospital is going to be doing a larger phase 2 trial. They just need to get the paper work done.
AL.
 

stevef

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AL that would be great

Al

That would be great. I wonder if they are keeping it low so not to get people's hopes up. Are you going to be taking part in it. If so keep us informed. I will be praying extra hard during this lent season for a cure or anything to improve and prolong life. May God bless everyone in this site and those who have ALS that are not in this site.
 

CindyM

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All this sounds promising and very hopeful. Finally some good news!
 

stevef

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how do they chose

my question is if they are going to do a study here in the US or Canada how do they chose which ones get Lithuim or just get riluzole. I mean how can a study chose to use it on some and not on others. Do you think they will now just test the effects on Lithuim and not use riluzole in the process. What i mean what are the ethics used to determine who might live longer and who might not.
 

Al

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It is my understanding if you are taking Riluzole you will continue and if not then just the lithium will be used. Not everyone wants to take Riluzole. In a phase 2 trial everyone gets the Lithium.
AL.
 
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ZenArcher

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I walked out of clinic today with a prescription for lithium carbonate 150mg 2x/day and blood work every two weeks. I had sent the report to my neuro as soon as it posted along with what I'd like to do and why and here we are. I'll take the first dose tomorrow morning and do the first blood work next week.
 

kelly

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wow

We just came back from an ALS clinic appointment. I asked them about the lithium studies, and they said they did not hear about them yet. I am impressed that you were able to get your prescription from your Doctor. Nice that you have a supportive neurologist.
 
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