A compound that researchers believe may lower the risk of Parkinson's disease (PD) and slow progression is now in the final stage of clinical testing. The Safety of Urate Elevation in Parkinson's Disease Phase III study (SURE-PD3) is recruiting people diagnosed with Parkinson's within the last three years. SURE-PD3 aims to enroll 270 people across 60 U.S. clinical sites for the two-year study. Forty-five sites are now actively recruiting. It won't be open long!
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p-oui
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To those people willing to participate in the upcoming CLINICAL TRIAL... I salute you ! You are making a critical contribution to making certain that drugs are safe and effective, that dosages are correctkand that side effects are thoroughly understood and investigated.
In December 23,2013
Michael J Fox announces: "Potential Neuroprotective Therapy Ready for Next Stage of Development after Michael J. Fox Foundation Funding..."
Here we are THREE YEARS LATER and we're now starting ONLY PHASE III testing ! Where, pray tell, is the URGENCY of this MJFF ? On the positive side, prospects for the future look good. The prospect for progression of my Parkinsons is not.
My question, Why should we heed advice of the medical establishment NOT to pursue taking this drug now - which is in the final stages of testing and is rapidly showing itself to be neuroprotective... and to wait patiently (while the inevitable progression of PD occurs)?
I am giving serious consideration to taking this drug on my own initiative. It is commercially available as a dietary supplement. Yes, the side effects are possibly getting kidney stones and gout, but I would request my physician to watch for symptoms of those problems and be prepared to handle them. Those outcomes can be addressed whereas inevitable neurodegeneration from Parkinsons is not.
I'm not in any way against Clinical Testing. However when drugs are showing themselves to offer a strong indication that they are neuroprotective, many people should consider taking them in advance of finalization of testing.
I am not asking physicians to endorse (or even suggest) taking this course of action. Instead they should offer their opinions and stand ready to assist in assessing outcomes and handling side effect. I know it may sound crazy to some, but I have this idea that "I get to decide" what happens to my body. There are times when patience is a virtue, and times when it is unwise.
Other opinions (especially from physicians... ) ?
If there are other people interested in pursuing a similar course of action, a "contribution" to science could be made by collectively gathering information on the outcome of taking this drug. I would be glad to be a gatherer of such. My email is frank.mundo@gmail.com.
This technique (its not really a drug, just a method for raising urate levels) has yet to be shown to help PD patients AT ALL. What's worse, there are well documented reasons to believe trying this is EXTREMELY DANGEROUS. Before going this route, please take a look at NAC (N-acteyl cysteine) and nilotinib.
There are some biochemical reasons to think that raising blood urate levels could be neuroprotective in PD. A preliminary trial titled “Inosine to Increase Serum and Cerebrospinal Fluid Urate in Parkinson Disease” has been done by a group calling themselves The Parkinson Study Group SURE-PD Investigators. This trial was /allegedly/ done for safety. It did NOT show any therapeutic effect. However, they did a futility analysis that showed that their data did not exclude the possibility that a future study *might* show an effect.
They raised the urate levels of 25 patients each, for 2 years, to produce “mild” (6.1-7.0 mg/dL) or “moderate” (7.1-8.0 mg/dL) serum urate elevation. According to this study, serious adverse events occurred no more frequently in test participants than in the control group. So they concluded this treatment was safe and they could get on with a larger study to prove it helps in PD. This study followed patients for a total of 100 patient-years. Here are the results of studies of high urate levels that followed patients for *thousands* of person-years:
Hyperuricemia and Risk of Stroke: A Systematic Review and Meta-analysis
"There is no universally accepted definition for hyperuricemia, but it is usually defined as serum urate concentration in excess of 6.8 mg/dL, which is the limit of urate solubility in serum … Sixteen prospective cohort studies representing data from 238,449 participants were included in the meta-analysis…. The pooled estimate of unadjusted RRs for stroke based on six studies was 1.41…"
A 41% INCREASE in the RISK OF STROKE for patients for what the SURE-PD investigators have labeled as MODERATE urate elevation.
Plasma Uric Acid and Hypertension in a Chinese Community: Prospective Study and Metaanalysis
”We conducted a community-based prospective cohort study comprising 7,220 participants …, who were free from hypertension at study entry in 1999–2000. During 4-year follow-up, 1370 men (19.0%) and 208 women (11.0%) had developed hypertension.
RESULTS: After adjustment for age, body mass index, and other covariates, the relative risks (RRs) of developing hypertension comparing the highest and lowest uric acid quartiles were 1.55 ….for men and 1.91 for women.”
A 55% TO 91% INCREASE OF RISK OF DEVELOPING HYPERTENSION in the highest quartiles. And what was the urate levels of the highest quartiles? For men, anything over 5.7 mg/dl. For women, anything over 4.5 mg/dl, LESS than the "mild" levels proposed SURE-PD investigators.
There is also data showing increased risk of kidney disease.
There is NO data from human studies showing raising urate levels does anything for PD. There is abundant data showing that raising urate levels seriously increases the risk of stroke and hypertension. There is already stat sig data showing NAC helps, and phase 1 data favoring nilotinib. So don't mess with urate!
Caution is wise. BTW I took a little inosine in supplement form for about a decade in the late 90s and early 2000s as I was trying to stay fit. I was also exercising and taking other supps and vitamins...etc. and I still got PD.
Buzz, in re-reading the phase III trial I noted it states "Based on epidemiologic studies indicating that people with naturally higher levels of urate have a reduced risk of developing Parkinson’s disease, Schwarzschild and colleagues at MGH and elsewhere previously showed that the disease appears to progress more slowly in patients with higher urate levels." so, alas, it doesn't claim to prevent PD. As I understand it, is another antioxidant which aims to get at glutathione benefit (direct assimilation of glutathione doesn't work for PD because of the blood brain barrier - again, as I understand it).
FMundo, I agree with you. I recently turned down the clinical trial because it is OTC and I am also considering mirroring the study on my own and having my doctor routinely check urate levels (I believe the trial does it once a month for the first three months and then every few months). My urate levels passed the entry for the trial. You'd want to make sure yours are at the right baseline.
I disagree with other reviews that the trial is not producing results. If that were the case it would not have progressed to stage 3. It is an extremely well run trial, is not designed by an RX company hoping to capture a huge new revenue stream, but was created out of the Harvard system and run out of Mass General, a flagship for the Harvard based healthcare system. In short, the trial has been run in an exemplary fashion. Further, it is a low cost readily available substance, it is not a potential new drug with a huge price tag, so it has to have merit to get this far because revenue is not propelling it forward and no fancy marketing exists for this trial. Similarly this is the case for NAC, (both are OTC antioxidants), though NAC is at a much earlier phase and is not being run by a major powerhouse in the academic world. Still, I am hopeful more studies will continue on NAC. I mirror the oral dose from the clinical NAC trial because it is a little less complicated than Inosine.
I hope to hear from any others who are taking Inosine on or off trial.
I have to confess to having considerable contempt for the way that Clinical Trials are overseen by the medical establishment. Not the way that they are organized and run... but the fact that so many go unregistered, such a high percentage are not reported on or reporting is prejudiced toward those with positive outcomes. Many are registered retrospectively. The problem and solution to the problem lies in the hands of those who underwrite the Trials, those who stand to benefit financially or professionally from them and those who invest their health (and lives) in them.
If you have an interest in how serious the situation is have a look at the following TED Talk:
The hidden side of clinical trials | Sile Lane | TEDxMadrid - YouTube
I honestly wonder how physicians proceed with any confidence at all in reviewing some Clinical Trial results. A sizeable percentage of CT's don't even have a name, number or email address for those who ran the test that can be utilized to delve more deeply into Trial results or negative outcomes.
The time has come for people with progressive degenerative illnesses to step around CT's (cautiously and after thoughtful review). The problems with CT's have persisted for more than a decade, in spite of having been identified (read Bad Pharma, 2006). We need to augment the current testing paradigm with alternative ones. Testing cannot continue to sputter along for years, we've got to up the pace. Times-a-wasting - so are lives.
I count over 25 drugs identified as potentially "neuroprotective" for PwPs in the last three years. These are either in Clinical Trials or have been identified as good candidates. How many were blessed last year as having made it over the finish line (Phase III completed successfully) in MJFF's Annual Research Review? None. How many disqualified? Maybe one or two?
I'm not holding my breath waiting for their Webinar in December.
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