[pygy_]

Not sure why you got downvoted. It would have to be done in double blind trials vs placebo, but it would be a great way to test the causal link between fungi and symptoms. You'd have to make sure the fungicides cross the blood brain barrier in patients.

[protomyth]

Haven't we studied the effects of Alzheimers enough not to need the control group? I worked in clinical trials and one study still haunts me knowing what happened to the control group.

[nonbel]

Sure, it fits right in with the plan to get rid of those pesky controls when testing painkillers too: "Drug companies have a problem: they are finding it ever harder to get painkillers through clinical trials. But this isn't necessarily because the drugs are getting worse. An extensive analysis of trial data1 has found that responses to sham treatments have become stronger over time, making it harder to prove a drug’s advantage over placebo. [...] For companies trying to develop treatments, one remedy might be to compare new drugs against their best competitors instead of against placebo — or to go back to conducting smaller, shorter trials." http://www.nature.com/news/strong-placebo-response-thwarts-p...

[zaroth]

Comparing old vs new is how it's done in cancer research. It's inhumane to prescribe placebo to someone in serious pain. You give them the old or the new, and they report how they felt.

In this case, since there is no concept of old or new, it's an entirely new class of treatment. So you give the current best-practice treatment without anti-fungal, and you give the same with anti-fungal.

Anyone in the study is agreeing at the onset that they have a 50/50 chance they will either get the current best practice, or the exact same thing but also the anti-fungal. These are volunteers who are helping move the anti-fungal research forward for everyone, in exchange for a chance of getting early access. They can also leave the study at any time after starting, but if they are in the anti-fungal group they would lose access to it if they did.

If that's not enough, there are cases (e.g. in cancer research) of de-blinding the study when there's a clear/strong positive effect and providing early access to all enrolled if it becomes obvious the new treatment is widely beneficial.

So I think we have the theory behind the ethics fairly well wrapped on how to roll out these drugs. I don't think in practice it works so well, the studies are often poorly run and poorly administered making them extremely more costly than they should be.

[protomyth]

The place where I worked did a pretty good job at administering the studies. The cost was in all the sampling and shipping. When your study is doing 1,000 sample kits with 5 samples every week day for multiple years, its going to cost.

I am still a bit clueless with all the research we have done with Alzheimer's why we need another control group?

[toast0]

The control group, with double blinds, provides evidence that the change in treatment causes the change in outcome. If you test without a control, the change in outcome could be a result of any other changes between the test protocol and previous control groups.

You might be able to do a small study without a control to test feasibility of the hypothesis, but I don't know if that would pass ethics review; would probably depend on the side effects of the anti-fungal. Another less invasive way would be to test for fungal presence in groups with and without the disease, likely through autopsies, since sampling a live brain seems intrusive.

[protomyth]

Here's my problem, we know the outcome of Alzheimer's, surly we have the data to go ahead without a control group? We've had them before.

[zaroth]

Is that 1,000 patients enrolled each being tested daily? That is a heck of a lot of testing!

Obviously depends on the patient population (in/out patient) but IMO a huge component of the cost is pushed off on patients having to spend a day getting to the study facility to give blood and urine versus dropping it at a local lab.

Then again, if Theranos tells us anything about variability of lab results, you certainly have to take every precaution to protect the integrity of your data.

[protomyth]

My sarcasm detector is busted, are you for or against control group in this situation?

[nonbel]

Perhaps you are basing this on the incorrect premise that Alzheimer's is understood at all. It isn't, and worse essentially no progress has been understanding it for many years. For example, the purpose of APP (amyloid precursor protein) remains mysterious. The same speculations are thrown around now as by the guy who discovered it in the 1980s.

At some point you need to start considering that something is seriously wrong with the research methods or theories. This fungal idea is good to explore, but the evidence provided here is not convincing at all.