Effects of Coenzyme Q10 (CoQ) in Parkinson Disease (QE3)

http://www.clinicaltrials.gov/ct2/sh...Disease&rank=1

This study is currently recruiting participants.
69 Study Sites

Verified by National Institute of Neurological Disorders and Stroke (NINDS), December 2008

Sponsors and Collaborators:

National Institute of Neurological Disorders and Stroke (NINDS)
Weill Medical College of Cornell University
University of Rochester

Information provided by: National Institute of Neurological Disorders and Stroke (NINDS)

ClinicalTrials.gov Identifier]: NCT00740714

Purpose
The purpose of this study is to evaluate the safety and effectiveness of high dosages of Coenzyme Q10 in slowing clinical decline in people who have early Parkinson disease.

Condition: Parkinson Disease

Intervention

Drug: Coenzyme Q10 with vitamin E
Drug: placebo with vitamin E

Phase: III

This trial is already outdated; hopefully it has been modified to account for new information and definitions.

http://www.clinicaltrials.gov/ct2/sh...Disease&rank=1

Here are some prior results from this study, which looks like it began in 1998. I'm sure this has sold a lot of CoQ10. This phase needs 600 pwp newly diagnosed; often these people are not public yet with their illness. It should provide a nice living for some researchers for years to come. Results, if negative, may never be published.

So far:

http://www.clinicaltrials.gov/ct2/sh...Disease&rank=3


see exclusion criteria in 1998 when this started...11 years ago. Conditions that mimic PD? These conditions would be..........? [today]

I think this could be a clinical clunker.

paula

I think the efficacy of coenzyme q10 for diagnosed PD is dependent upon the factors responsible for causing the disease or unmasking the disease. I know in my husband's case, the use of 1200 mgm/day of coenzyme Q10 resulted in incredible regression of symptoms--his masked facial expression abated, his shuffling walk was much less pronounced, the bradyknesia not as profound--the only thing it did not affect was the hand tremor. At this time, my husband was taking no anti PD meds. Just coQ10. If he misses a dose of coq10, he reports that he can feel the difference--his shuffle becomes worse, his posture becomes worse. etc. Placebo effect? I doubt it, since he does not deliberately miss the coQ10 dose--just gets busy or forgets it, and remembers when his symptoms increase.
The reason he originally took coq10 was due to the research we did on metabolic consequences of fat soluble lipitor---statins deplete coq10 levels as measured in plasma, platelets and muscle tissue. Perhaps the reason coq10 was so helpful for my husband was due to the fact that its depletion triggered the PD or exaccerbated the symptoms of PD.
Again, the problems with this study is that all PD patients are lumped together--difficult not to do when no true etiologic factors (except for genetic ones) are known. Patients like my husband may be the ones who truly benefit vs those whose PD is not linked to use of statins. He will continue taking it along with his now anti pd meds.

Olsen, it sounds like your husband has been taking CoQ10 on his own, not as a part of the earlier studies. Many others have as well, after reading about the positive results reported on a phase II trial, which ended in 2003 - concluding a larger placebo controlled study should be done next (and it is ... in 2009. CoQ10 can be purchased as a food supplement -- if you can afford the high doses suggested in the earlier study. At that time I think it would have cost about $200 a month The company that produced the CoQ10 for the phase II study even advertised their product on the Web to PWP, as the "purest" form available, and warned that what you buy at Walmart was not the same. Indeed there are no standards for food supplements, and you might mot be getting what you pay for.
But the real point is there are likely thousands of PWP who were and are taking CoQ10 - who would not qualify for this new study. But wouldn't the data on their experiences, such as your husband's, be valuable, if it could be collected and analyzed?

there probably is no way now to effectively obtain the info re:use of coq10 without benefit of clinical trials . Too much reliance on memory (ie what were the symptoms before starting the supplement? how were these affected? what are they now? etc.) coupled with the polypharmacy most PD patients are on--how to separate out what is responsible for what. I remember when my husband first began taking 1200 mg coQ10/day, he spoke with Clifford Shults MD (who is now deceased), the first author of the original study on mega dose CoQ10 in PD patients and asked about dosage, preparation and lab testing to determine efficacy. Shults was furious that my husband was taking the supplement on his own--ie without aegis of a clinical trial. commented that if all PD patients did that there would not be enough for a clinical trial. I do understand this concept, though, that conversation took place in Aug, 2004. It is now Jan, 2009, and the trial has not even recruited participants. Thus far seems there are no adverse effects from taking coq10--and we are hopeful at least some of the muscle tissue,plasma and platelet CoQ10 levels depleted by statins have been normalized after 4 1/2 yrs. of suupplement therapy.
We were told by an acquaintance who is a pharmacist that Sam's coQ10 preparation was "soluble enough". I do know the preparation used in the original study was developed by "vitaline formulary" (they had a booth at the world parkinson's conference in wash a couple yrs ago and advertised that fact). Individuals who belong to the one of the mitochondrial dysfunction groups, I think it is the United Mitochondrial Disease Foundation, have a "group buying rate", thus receiving a discount from Vitaline Forumlary, negotiated by several members of this group. No reason we could not band together as the "neurotalk communitites Parkinson's Group" and negotiate our own group rate. Or one could join UMDF--mitochondrial dysfunction is thought to be an underlying cause in Parkinson's disease--thus would qualify for the discount.

Madelyn, your husband is the first I've heard about with symptom relief from CoQ10. Not that there aren't many others, I've just not paid much attention because [and please correct me if I'm mistaken - this really confuses and bothers me] the research on CoQq10 is for early stage pd; DXed but not yet on meds.

I found this:
http://clinicaltrials.gov/ct2/result...=&lup_s=&lup_e=

There I saw one trial for midstage pwp here:
http://clinicaltrials.gov/ct2/show/N...disease&rank=3

and the results here and typed below:
http://www.ncbi.nlm.nih.gov/pubmed/1...?dopt=Abstract

CONCLUSIONS: Nanoparticular CoQ(10) at a dosage of 300 mg/d is safe and well tolerated and leads to plasma levels similar to 1200 mg/d of standard formulations. Add-on CoQ(10) does not display symptomatic effects in midstage Parkinson disease.

I realize that neuroprotection doesn't become apparent overnight. The midstage trial was 3 months long...? correcting this...trial dates indicate a two year span..not sure where i saw 3 months. .
oops I was correct it's in the first sentence:
"The treatment phase includes three months period of 300 mg Coenzyme Q10 per day or placebo"

And yet, I went to a health food store at the request of my husband and they sold us CoQ10 even tho I am twenty years into this disease. New research they said and they made an appointment for me to talk with someone who knew more about PD. I told my husband chances were excellent this person didn't know more than me, but I went. We had my grandson with us - 5 yrs old - they made us wait and wait while he chatted here and there, finally engaging in a long conversation with someone. My husband, beginning to believe me about knowing more agreed to return the unopened CoQ10, and we left.

The clerk came out and asked why we were leaving - I said problems with my meds. And that was that.

To my knowledge, there is no justification for anyone to be taking CoQ10 beyond early stage pd at this time.

Six years between phase II and phase III. If I am missing something - would someone please correct this information? I don't like being correct about these things anymore.

Have to expand my signature line even more to include:
what is real?
paula

Paula, How utterly rude the behavior of the clerk--and you are correct, he probably knew less than you about PD and coQ10, and did not want you to know that, thus the delay until you left.
My bias is that a fat soluble statin was responsible for the onset of my husband's PD--whether it "unmasked" the disease or directly caused it, I am not certain (how can one be??). Statins interrupt the pathway to production of coenzyme Q10--this isoprenoid shares the same pathway as that leading to cholesterolgenesis. There are several other "pleiotropic" effects of statins that may also be responsible, but depleting the body of one of the metabolites found to be depressed in all PD patients irregardless of their statin status, seemed a good place to begin. Thus the decision to begin CoQ10. At that point, coq10 was the only anti PD drug my husband was taking, and this was even before his diagnosis, thus early in the disease. The response was a very positive one--though was quickly followed by use of other vitamins and minerals as well as supplements focused to replace what statins had depleted/interferred with. The first anti PD drug my husband began was Azilect, about 3 months after beginning coQ10., though his initial symptoms were much reduced prior to taking Azilect. Amantadine was added sometime later. I have not followed the Phase II trials very closely, since I ascribe to the belief "if it ain't broke, don't fix it"--since coQ10 helps my husband, he will continue with it until he feels it has no benefit. I do know there were mega dose coQ10 clinical trials slated for ALS, Alzheimer's and huntington's. Seems a couple of those were dropped for lack of efficacy, though again, I have not followed those trials.
As for the increase in symptoms if he forgets to take coQ10, I do not know if the prior statin use accounts for this or not. Again, I feel "parkinson's disease" is not one disease entity but a constellation of different disease states, with many different etiologies. Thus what one person responds to, another may not. Maybe it would be more correct to label these "parkinsonism" instead of "parkinson's disease". Would be interesting to know if any others who respond positively to coQ10 also took/take a statin. I do not have an opinion as to whether coQ10 should help you at this stage. It is expensive--though if you belong to Sam's or know someone who does, their product is supposed to be quite good and not as expensive. Wish this stuff was more definitive; living with the disease is enough without feeling one must also guess what will help! madelyn

How interesting Madelyn, i'm too off to elaborate but you have given us something to really look into. More tomorrow.

paula

I have not had any problems with cholesterol [knock wood] so I haven't read that much about the statin issues. If anyone else would like to read about statins and pd, here's a google search. Your post is there Madelyn.

http://www.google.com/search?parkinsonhl=en&q=fat+soluble+statins+and+%2 7s+disease&aq=f&oq=

Sounds to me like your husband did the smart thing by starting CoQ10; his doctor should not have been upset - Waiting for the trial and then risking getting the placebo, which could have worked as well as the real thing, thus ruining it for everyone and on and on.....the cycle of failure. ..... would have been unwise.

I think asking people if they were on statins before pd sounds like a good data collection idea for a possible subtype, as well as as one for trichloroethylene exposure. Toxins are blamed, but not named. There's a poem about it....lol

600 early stage pd on no meds yet. I wish them luck, would love to know who is getting paid for what. Seems like this one could have been done at home with online communications.

paula

Again, I think parkinson's disease is not one discrete condition but a collection of discrete conditions that all lead to a final common pathway of neuronal loss within the substantia nigra (as well as other areas). Following this theory, different patients with parkinson's symptoms may have very significant physiological differences in relation to triggers or unmasking events and thus significant differences in which treatments they are likely to respond.
Collection of data would be soooo much easier with a centaralized data base via a federally mandated patient registry. Or neurologists and MDS physicians could develop this tool--would require funding, and patient consent (re:HIPPA laws) wonder if MJFF has considered developing/backing such an undertaking? Someone with grant writing abilities could streamline the endeavor.