How safe is this, really?

[simonsays]

An investigational medication for Alzheimer's. The informed consent does not list any of the side effects in the animals that have been tested, nor does it explain what the drug is designed to do (besides the very vague "to treat Alzheimer's"). The drug has only been tested in less than 500 humans so far. And none of the tests that will be conducted during the study measure brain function (MRI's, CAT Scans, etc), except for the neurological exam where the doctor asks you to close your eyes and touch your nose and stand on one leg, etc. And the purpose of the study is to test the maximum dose before unacceptable side effects start to show up. I mean, that's worth a little more than $2000 a week, right? I might have to back away from this one...

[travelingrat]

if you have enough money, i would say skip it. i am in the older age group for studies. the only super bad experience i have had in studies was 3 years ago with an alzheimer's drug. also, LAST year i screened for a study for a similarly-UNtested -in-humans alzheimer's drug at one of the large southwest cllinics (PM me for more info if you want). the screening was beyond ridiculous. everyone had questions --we were all experienced rats, all over 55 -- and they of course told us, refer all questions to the doctor at the physical exam. he knew NOTHING. we were all nervous because that drug had had studies in animals where rats and monkeys had died. this was one of the many times i phoned an IRB and received a useless response. i explained how the doctor had not answered ANY questions and thus my consent was useless ...plus they had asked us to sign BEFORE being able to ask questions (not that they were answered anyway!).

for example, the consent form said that monkeys had developed persistent tremors similar to parkinson's disease tremors, with some developing "permament" tremors. i asked if they could find out how long the tremors lasted, that i did not want to test the drug if i might end up with permanent tremors. i had some other questions in a similar vein. also, i said that i thought the dose was being escalated too quickly (there were to be 5-6 cohorts) for an elderly population and i did not think the pay was high enough for the risk involved and i asked them to evaluate that as well. at first, i received an email back that said that they would send me a "measured" response. the email was sarcastic in tone. finally, 1 day before the study, they sent me a one-sentence email saying, if you think the study is too risky, don't do it.

this is actually a really long story. as it turned out, they stopped the study midway into the first group and cancelled the second group. but then, 2 months later, they set up group 2 again but in a strange way, with way fewer people. i opted NOT to do the study, but i had many older friends who did and they said there were awful side effects.

on the other hand, i have done studies in which the consent forms listed side effects that sounded scary, and not a thing happened. but i did those studies after having been able to ask many questions, plus they were at clinics i trusted. my opinion is that some clinics really care, and some clinics really do NOT.

so i don't know if this reply will help you in any way but i will post it anyway. you could consider joining the trial and then dropping out if you start to have bad side effects. if you do that and do experience bad side effects, get the IRB on board if you can. i would even insist on phoning the IRB from the dostor's exam room. if i had done that in 2011, it would have helped considerably as that doctor played down my symptoms in a big way, especially when i was not present.

where is this study taking place? have you done studies there before? if you trust them, that would go a long way to influencing the decision. best wishes to you!

[simonsays]

Yes, the side effects listed for the relatively few human subjects that have been tested are pretty minor. But given that, even as a healthy individual, I have no idea what is happening in my brain, I'm not sure if I would be able to report anything unusual (I mean take a look at concussions in the NFL, that stuff shows up YEARS later). I would feel more comfortable if they at least gave me an EEG to monitor my brain functioning, much like they monitor my enzymes, heart rhythm, and vitals
But anyway, yes, I am am actually very short on funds at the moment, but I'm still leaning towards sitting this one out. I'm actually hoping that I'm an alternate, so that I can get a little bit of money, and then screen for another study.

[travelingrat]

the study that i screened for (and decided not to do) in early 2013 for an alzheimer's drug had been tested almost exclusively in animals, with animal deaths reported, attributed directly to the test drug. they also attributed parkinsonism directly to the drug. they required a brain scan and also that the brain scan electrodes be worn uously for 24 hours before and after dosing. an outside company was brought in to do this. they were NOT paying $2000/week in that study! as i said, there were many side effects experienced by the first cohort (i had good friends who did do the study and told me their experiences). my decision not to do the study rested mainly on the clinic's AND the IRB's lack of transparency and their unwillinglness to answer my questions or address my concerns. plus, it was at a clinic where many lab rats have had bad experiences over the years. they cancelled the second cohort but then rescheduled it a month later. i screened for that one too (they paid $75 for the brain scan at screening) but again, felt that they did not adequately answer my questions and i skipped that cohort too. supposedly they were going to keep doubling the dose ... i have often wondered if they went ahead with those cohorts or not but i moved out of the southwest back to florida.

the 2011 study for a different alzheimer's drug --the one where i had numerous bad side effects -- did not offer any sort of scans. i did not know at the time that i could have requested a brain scan. weeks later, after i had already quit the study, the IRB said that they would insisted on one for me if the clinic doctor had accurately reported my horrible side effects. by then, i was gradually feeling better and i was 2000 miles away from the clinic so i declined.

as i said in my above post, i have been in studies which listed side effects which sounded terrible but i experienced zero side effects. i think most of us have been in studies like that. when i need money, i need money.

ironically, in 2012 i was in another study for an alzheimer's drug (i am in that age group!) in a wonderful clinic in Florida (NOT the daytona beach one!). we had a spinal tap the first day and the second-to-last day. none of us experienced any pain or problems. one woman had some aching. i also was in a study where they videotaped us repeating words and numbers we had heard 10 minutes previously. this study involved no drugs and there was also a spinal tap. i have also done skin biopsy studies with zero problems. i was also in a long 30-day inpatient study for alzheimer's which caused many of us to have fevers and very low blood pressure and my thoughts were fuzzy ...VERY unpleasant ... not soing i would want to take if i did have alzheimer's! so unlike leopold, i would do studies with spinal taps or studies with skin biopsies BEFORE doing a study for a brain drug where i felt it had not been tested enough previously. looking at the data from previous studies is a big deal for me and i try to ask at a lot of questions before going into any study.

personally i prefer if i possibly can, to stay away from any studies connected with brain stuff, including drugs to treat alzheimer's or schizophrenia. but if i do decide to do such a study, i definitely want my questions answered at screening. lots of clinics i have been to ask you to sign the consent before there is a chance to ask a single question, and then have you return on a different day (sometimes a weeek) later for the phsyical exam and the supposed opportunity to ask questions. if one has had traveling expenses at all, this can make for increased reluctance to decide against a study. i believe this goes against the whole idea of informed consent. but that is a topic for another thread i guess.

so if you do need the money, go ahead and try it. probably you'll be fine and if not, you can quit ...but if you are going to do that, phone the IRB first. my chief mistake in 2011 was in not phoning the IRB first. all i could think of was that i did not want to swallow one more dose!

[mike]

You can withdraw consent at any time, so I'm not sure that it matters if they don't answer all of your questions before you sign consent; other than it possibly causing you the inconvenience of wasted time and travel expenses, which as we all know can happen with any study for a myriad of reasons.

What you say about clueless doctors seems to be a common occurrence here, though I don't recall experiencing it myself, when I have asked doctors questions they have always been knowledgeable about the drug and it's effects.

And it seems to me that every drug lists very unpleasant if not awful (like sudden death!) side effects as being possible.

But if the drug really seems that bad, and the doctor doesn't know jack, I would stay away from the study.

[diamond]

I did an antidepressant study, 38 days, dosing EVERY DAY... and I ended up having tremors. They sent me for brain scans and DID find abnormalities! A week later, they sent me for another brain scan and it was normal (or so they say). The dose was very high. Crazily, this drug is on the market now and millions use it for depression and to quit smoking. I generally stay away from any drug regarding the brain in any way nowadays. There is a REASON they want you in-house for SO LONG on these studies.