Chemister wrote:
In all likelihood, what basic requirements would we be talking about then for the individuals who wanted to utilize this protocol?
This is a substantial project and that is why it will probably never will be completed. Even if it did, a pilot-study in mice would probably be required.
This is a
quick & rough outline:
There are two phases to this project; the first is to establish the model. For this phase we would need a number of volunteers I would aim for more than 20, preferably 40-50, where some, say ½ of them are healthy.
We also need to figure what indirect indices of oxidation to use (as many as possible in the initial phase).
Then all subjects will be asked to abstain from antioxidants and to take a one week wash out period before a base-line test is taken.
Then all participants would have to be infused with low, medium and high doses of chlorite (where "high" is roughly equal to NP001-regimen and we'd have to use your esimates to establish what low and mid is). Needless to say we would have to figure how long these treatments should be and there may (or may not) have to be wash-out periods between these before increasing it from low to mid, etc..
After that the calibration model may established and subsequently interpreted to identify which one out of the original broader spectrum of oxidative indices used that are most significantly and dose-dependently linked to the chlorite exposure.
The smaller number of so qualified indices of oxidation is subsequently used to establish the final model.
In the second phase that model may be used to roughly predict the oxidative index (corresponding to arbitrary NP001 dose/exposure units) for someone who has; a) gone through a wash-out period and taken a base line test and thereafter b) consumed a certain amount of OSC during a predetermined period and taken a second test (containing the qualified indices).
Chemister wrote:To what extent would these individuals have to get actual lab testing done on their blood samples (and how affordable would such testing be)?
People aiming to use the model would have to take two blood samples and submit the results. The cost is depending on the number and the identity of the qualified predictor indices.
Chemister wrote:How much might the protocol have to be calibrated to each individual in order to yield useful information?
I would expect that an antioxidant wash-out period and base-line test may be required, per above.
Chemister wrote:How much could we expect the average PALS to have to rely on help from others (either on this site or elsewhere) to interpret their results, perform calculations, etc.?
They would need professional assistance to draw blood and perform the blood works. But the results could be submitted anonymously in a web form and the results displayed in a simple graph.
The risks are obviously that there could be errors in any of these (manual) steps, plus of course possibly also that the model isn't general enough.
This means that there is a possibility that a broader set of blood-work parameters may routinely have to be used in order to determine if a particular subject is sufficiently similar to the multivariate diagnostic domain spanned by model, so that appropriate warnings may be provided in case an "outlier" is using the model.
Don't just ask what scientists can do to speed up the solution for ALS or when they will do it, instead ask yourself what you can do right now to solve ALS asap.