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ShopGuy last won the day on October 9 2015

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About ShopGuy

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  1. Last Friday, I finished the five-day inpatient portion of a Phase 1 clinical trial for BIIB054, an immunotherapy treatment for PD being tested for the pharmaceutical company Biogen. Details of the trial (still recruiting at some locations, I believe) are here: Overall, the experience of participating in the trial has been very worthwhile. As the saying goes, there were stretches of boredom punctuated by brief moments of--okay, certainly not terror--but heightened anxiety. To prepare for the trial, I was required to stop some medications, and undergo blood and urine tests, an EKG, an MRI, and a DaTScan. Blood, urine, EKG, and MRI were to confirm good health (apart from PD); the DaTScan confirmed my dx. Cost of all testing (including DaTScan) was covered. Infusion of the study drug was done during a five-day, four-night inpatient stay in a research clinic. The study drug (or placebo) had already been administered in higher doses to 40 volunteers without PD, and a handful of volunteers with PD, with no significant side effects. My MDS is one of the study doctors--I felt the potential benefits for research and for myself outweighed the modest risks. I was well compensated for travel and time, and the catered meals were *far* better than hospital food. Day 1 was a battery of blood and urine panels, plus multiple EKGs, blood pressure readings lying down and standing up, MDS exams, and collection of cerebral spinal fluid via lumbar puncture (spinal tap). I was more than a little nervous about the spinal tap, but it turned out to be much less of a big deal than I imagined. Very little pain (just a little poke from the lidocaine injection, and a bit of pressure when the needle went it). After that, I was hooked up to radio telemetry to continuously monitor heart rate for the next 48, and spent the next several hours in the clinic's waiting room. By the evening, when we moved to the clinic annex where the bedrooms were located, I had a fair amount of discomfort in my lower back. This may have been a reaction to the lidocaine. I was given ibuprofen, which provided good relief, and was fine the next morning. There was another volunteer participating in the trial at the same time--that, plus books and internet, was a good distraction from a whole lot of sitting around waiting for the next blood draw, the next EKG, etc. Day 2 was infusion of the study drug (2/3 chance, two possible doses) or placebo (1/3 chance). Infusion was via IV and took about an hour. Some combination of fasting, lying flat on my back for an hour and who-knows-what caused pretty bad heartburn during the last 15 minutes of the the procedure. When I mentioned this, I was given immediate EKG and had blood pressure checked to rule out possible complications. For the rest of the day, we had regular blood draws to monitor the drug as it moved toward and crossed the blood-brain barrier. Day 3 was more of the same. The telemetry came off, and by afternoon, we were given the chance to take a shower and get out of the clinic for a few hours. I met up with a friend in the area and we went for a hike in a nearby park. Good to move the legs after 2 1/2 days sitting. Day 4 was another MRI in the morning, more routine blood draws and EKGs, plus another afternoon release (for good behavior?) On Day 5, when the results from the MRI came back, we had final MDS exams, and were released. There will be a series of followups over the next 16 weeks, including two more spinal taps and another MRI. I was told BIIB054 isn't expected to offer symptomatic benefits, but may (if it works, and if I got the active drug) slow progression by 4-5 times the rate without the drug. As I understand it, the drug is an antibody engineered to bind with the clumping form of alpha-synuclein, and clear it from the brain. The 'moonshot' (as my MDS put it), is that the drug will prevent the formation of Lewy bodies, and even reverse some disease progression. Needless to say, everyone at the clinic is very excited about this trial (and very appreciative of the patient volunteers). Given the lack of negative side effects, a Phase 2 trial is expected very soon (perhaps this fall), and it appears Phase 1 patients will also be eligible for Phase 2. I don't know if Phase 2 testing will be as invasive or require an inpatient stay. We often hear that new drugs take a very long time to pass human trials and get released to market--what I heard from clinic researchers was that with good recruitment and positive results, new drugs can be released quite quickly, perhaps 4 years or less from initial human testing. I feel fortunate to have an MDS committed to active research as well as top-notch patient care, and clinical research facilities located relatively close by. In fact, my MDS will be conducting Phase 2 trials of the drug Nilotinib soon. I don't know if I'll qualify, but it's exciting having cutting-edge stuff happening so close to home. Finally. a little soapbox: with a number of promising PD treatments in the pipeline, this is an excellent time for PWPs to get serious about research, by volunteering for trials (not for everyone, I know), and/or by contributing to organizations that support research (like the Fox Foundation), and advocating for increased support and funding for basic research through NIH and NSF. The basic research underlying all these new treatment has been twenty years or so in the making--too long a horizon to payback to expect private companies to do it alone.
  2. Happy birthday, Stump! I'm home now from the inpatient portion of the trial, none the worse for wear. I'll post later today or tomorrow with some details of the experience--it was thoroughly worthwhile.
  3. I think a lot of credit has to go to the 40 people without PD who went thru the trial first, to establish safety before the PWP cohort. They may have had many different reasons for doing so, but I appreciate that they were willing to take that kind of risk. And I agree completely--if targeting mis-folded proteins works, it will be huge for quite a number of diseases much worse than PD. Even if this turns out to be a dead end, at least we'll have learned what not to spend time and money researching. That's important, too. Not looking forward to the spinal taps, however...
  4. Hello all, It's been a while since I've posted. This coming Monday, I start the inpatient segment of a Phase 1 double blind clinical trial, testing a new immunotherapy treatment for PD. Details of the trial are here: The trial is fairly invasive, including IV administration of the study drug (or placebo), five days of inpatient stay with 24 hour monitoring, multiple lumbar punctures (spinal taps), and MRIs. To qualify, I've had to drop all meds except Azilect (people on stable doses of Sinemet also qualify, I believe), and undergo a series of health screens, including DaTScan. Reasonably good health (apart from PD) and a positive DaTScan are required. Since most Phase 1 trials don't pan out, and I have a 1/3 chance of getting the placebo, I'm not expecting personal benefit. But the science is very cool--the hope is the compound (engineered antibodies) will clear misfolded alpha-synuclien proteins from the brain and dramatically slow PD progression. Immunotherapy treatments from other companies have already made it past Phase 1, and are starting Phase 2, so even if this particular trial doesn't produce good results, it seems the general approach has a lot of promise. My MDS is one of the study doctors, so I feel like I'm in good hands, and compensation for my time and travel is quite reasonable. Certainly there are risks involved, but I believe they are relatively small and manageable. I'll post more as the experience continues.
  5. "Years and years" seems overly pessimistic. Unlike nilotinib, which has shown limited promise is a single, uncontrolled, very small study, the results for aducanumab are from larger, double-blind Phase II trials. Results were compelling enough to be published in Nature. Given the prestige of that journal, and that Alzheimer's is the most common neurological disease in the world, there's going to be no lack of funding and volunteers to start Phase III trials as soon as possible. Give Phase III three years to produce results, and if they look good, there will be considerable pressure for fast-track FDA approval. So assuming the drug passes Phase III (big assumption), it might hit the shelves in 5-6 years. Sure, that's going to be too late for plenty of people. But that's always the case with any drug. The alternative is to allow drug companies to rush useless and/or lethal compounds to market, with little oversight--in the long run, that's going to kill a lot more people than might be saved by a less rigorous drug approval policy. After all, something like 90% of drugs that show promise is a petri dish or animal model fail to work in humans. The good news from my point of view, other than a potential treatment for a disease I consider far worse than PD, is that immunotherapy drugs for PD (similar to aducanumab) are already in Phase III trials--that much closer to market if all goes well. Nilotinib, as far as I know, is *not* a narrowly-targeted immunotherapy drug, and already carries a black box warning for use in cancer patients. I suspect that, even if it does pass Phase II (safety) and Phase III (efficacy) trials for PD, nilotinib will be a treatment of last resort for patients with very advanced disease. It's also not unlikely that the 'miracle' results seen in one tiny study (and over-hyped by the researcher, in my opinion) will disappear with high-quality double-blind studies, leaving nothing but another dead end. It's also worth remembering that without solid, basic research in biochemistry, protein structure, and computer science (to build supercomputers capable of simulating complex protein folding), none of this would be possible. Research showing PD, Alzheimer's, and other neurological disorders results from misfolded proteins (are 'prion-like') took place a decade or so ago--we're seeing the pay-off now in the form of a flood of new drugs moving into human trials.
  6. Thanks for the link, Patriot. Couple of points: "Of note, studies have suggested that experienced clinicians can diagnose PD with greater accuracy than formal diagnostic criteria. Therefore, until definitive validated diagnostic markers are available, clinical expert opinion will be the gold standard diagnostic technique in life." --Suggests to me that if diagnostic criteria and expert opinion are in conflict, preference should be given to expert opinion (i.e., dx from MDS). "A benchmark for an absolute exclusion was occurrence in less than 3% of true PD…" --Implies that 1-2% of true PD cases may present with an "absolute exclusion," such as normal DaT scan. Presumably, this would be early in the disease process. Rare, but with a few hundred forum members, it should turn up a few times. The overall intent of the diagnostic criteria seems to be distinguishing PD (esp. early PD) from *more* serious conditions (such as MSA, PSP, others), rather than reassuring patients with normal DaT scans that there's nothing wrong. As you've pointed out many times, there's a lot worse than PD out there--PD-like symptoms (esp. severe ones) with a normal DaT scan prob. isn't good news...
  7. Palfreman's book is great. Thorough, very up-to-date on the science. And, while he keeps his own experience in the background, Palfreman happens to have PD.
  8. HRC has been in the public eye for decades. The idea that she has had PD (and been treated for it) long enough to develop levadopa-induced dyskinesias, on/off episodes, and freezing, and that the only person to notice is an untrained, 'pharma-bro' rip-off artist is ludicrous. I mean, the DNC couldn't keep their internal emails secret for more than a couple months--it's hard to believe no one would leak HRC's 'secret', if it were true.
  9. My symptoms are still quite mild, and the dopaminergic med I use (Neupro) is supposed to provide a more or less continuous dose for 24 hours. Still, most symptoms are noticeably worse in the morning. A couple hours after waking, I usually feel 90-100% normal. Late afternoon some days, discomfort from dystonia and some fatigue creeps back in.
  10. Fitbit give you a running total of steps/miles/'stairs' climbed/heart rate and time on the little screen. Steps/miles/stairs roll over to zero every day--you can also set it to record a workout during the day. For stats and daily records over time, the fitbit connects wirelessly to computer or phone and that data is displayed in an app. Hope this is clear--I'm sure the fitbit website shows how it works.
  11. I've had a Fitbit Charge HR for a year. Works for me--tracks steps, elevation change, heart rate. You can wear it to bed as a sleep monitor. Wireless sync with computer or smart phone. Needs charging every three days or so.
  12. Hi Lonnise, Azilect often takes a few weeks to build up and have an effect, but after 6 weeks I wasn't seeing any benefit, and seemed to be having mild side affects (headache, heartburn). MDS advised switching to Neupro. Titrated up to 4mg (supposedly the lowest effective dose for PD). Good relief of motor symptoms, although nighttime nausea for the first 6 months or so meant I usually took the patch off at bedtime, rather than wearing it 24 hours. Added the Azilect back in after getting a grant from the Patient Access Network, which made both drugs affordable, and with the idea that the mild relief Azilect provides might remove the last bits of slowness and rigidity without having to increase Neupro (which is an agonist). Long story short, earlier side affects from Azilect didn't return, and nausea from Neupro is pretty much gone--I wear the 4 mg patch 24 hours now. Whether or not the Azilect is doing much I can't be sure--for now I've got a regimen that seems to reduce my tremor, and pretty much eliminate rigidity and slowness most of the day and most of the time. So far, no sign of compulsive behaviors from agonist, but I'm wary of either pushing the dose higher or trying another (e.g., Mirepex). Re: telling employers and acquaintances--I'm with Daven. Informing an employer seems esp. risky--in spite of ADA, it's far too easy for it to work against a person. Nor would I want an employer fearing the worst the next time a Robin Williams-type thing brings attention to PD. I have told my direct supervisor, but only because I've known him for 20 years and consider him a friend. I may go public in the next couple years, for professional reasons too complicated and provisional to go into here, but if and when I do, I'd like to be able to reassure folks that I've been diagnosed for a few years without it affecting my work or being noticed.
  13. Isn't Plexus a novel by Henry Miller?
  14. Seems like the answer to the questions, 'What is the prospect for a cure?' and 'What diseases...were cured in the past 100 years?' depends on what is meant by 'cure.' If folks are looking for a single operation or a short course of treatment to be PD-free forever, that seems a very long way off (if it's even possible). For me, something that would result in a symptom-free, normal lifespan would be good enough, even if it still required daily meds. I think of that as analogous to the Type 1 diabetes 'cure'--don't want to downplay the challenges my friends with Type 1 still face, or the daily hassles of dealing with insulin pumps, blood monitoring, etc., but 100 years ago they would have been dead within a few years of diagnosis, and even a couple decades ago, their lives would have been much shorter than average, and likely included amputation and blindness near the end. It may be the reason l-dopa is still the gold standard 50 years on is the same reason insulin is still the gold standard in Type 1 diabetes: replacing what your body needs but can no longer make is a pretty good strategy. PWP could use a better delivery system--it's not crazy to think something less clunky and more effective than Duopa will be available fairly soon. Like just about everybody else on these forums, I'm not a PD researcher--just a reasonably well-educated PWP who keeps up on the literature. But I'd guess a real cure would look something like this: a course of drug treatment to clear alpha-synuclein tangles from the brain, preventing further damage to dopamine-producing neurons. At least two immunotherapy drugs to do this are in advanced clinical trials, and Nilotinib (which might do the same) just passed Phase 1. Maybe the treatment would be a one-time thing--more likely it would have to be repeated. If the immunotherapy drugs succeed, they might be available in 5-7 years. The important thing is, until 10 years ago or so, no one had a clue *why* dopamine neurons were dying. Now researchers are pretty convinced mis-folded proteins are to blame, not just in PD, but in AD, ALS, and other neurological diseases. If protein-clearing treatments have to be repeated, exercise and drugs to slow progression might help lengthen the time between these treatments: exercise is available now, to just about everybody, and at least two drugs that may slow progression are in Phase 3 trials. Since both are available now, either FDA-approved for another use (Isradipine), or OTC supplement (inosine), if either or both are successful we will have immediate access. With my MDS's approval and support, I already take Isradipine off-label (costs me ~$9/month), and may start inosine (my MDS is involved in the clinical trial). I suspect most PWP would be happy if the 'progressive' part of 'progressive and incurable' was off the table. For folks like me, who still have relatively minor symptoms that respond well to dopamine replacement, it might even count as a cure. Replacing lost neurons, with stem cell treatment for example, is prob. much further off. It may not ever happen. But an effective treatment that halts progression would create a huge incentive for screening and early diagnosis. Two years post-diagnosis, I still work full-time at a complex, physically and mentally demanding job, go on multi-day backpacking trips, and recently climbed my first Cascade volcano as a 22nd anniversary trip with my wife. This fall, we're going to Iceland for two weeks--something we've wanted to do for years, but prob. would have kept putting off, if not for the diagnosis. My MDS thinks I can keep going like this for at least 10-15 more years. Could I do what I do without the meds I currently take, or my exercise regime? Not sure--and I don't plan on finding out. But there's no way I could hope for this prognosis in the days before l-dopa. That's not a cure, but I'll take it.
  15. Based on my own experience and the reports of many here, I'd guess many PCPs miss PD, esp. in the earlier stages and in younger patients. My PCP did--he's a great family doc, but diagnosed 'benign' essential tremor and reassured me it wasn't PD. To his credit, he has no problem referring me to an MDS when I had nagging doubts about his dx a few months later. MDS knew it was PD within about 15 minutes, even though my symptoms are quite mild. As everyone else has said, get your PCP to give you a referral or get a new PCP who will. 90 minutes drive isn't bad to see an expert--that's how far away mine is--if you do have PD, you'll prob. only need to see your MDS 2-4 times/year.