Replies to post #291039 on Anavex Life Sciences Corp (AVXL)

[nidan7500]

abew4me

Recall that Biogen's MC shot up over $20 Billion when they announced the possibility that their drug, aducanumab, might be effective.

I CLAIM: The last thing BIG P and their investment constituents want is a fast/reliable/accurate measurement of CNS disease treatment efficacy. If such a tool suite did exist then highly skilled science would make short work of any related CNS disease problems.

https://pubmed.ncbi.nlm.nih.gov/31264318/

What IF, direct measurements of subject cognition status or status changes could be done during a trial and WHAT IF the efficacy of any (BIIB-example) treatment were quickly and accurately determined (worthless) during trial using Actigraphy? Suddenly Biotec would be based on real science and not the obviously flawed investor/flash science/corrupted system in place now.

Would such a quick WS scam ($20 billion overnight is a lot of motivation) be even possible? Huh, maybe there are a lot of researchers who would rather rely on existing (very fuzzy/basically worthless) methods of measuring-evaluating cognition or cognitive changes?

Is it possible that the LAST THING some BP want to see is a REAL TIME AND ACCURATE trial metric like ACIGRAPHY? That case could be made? Even though the current observation-translation metric is done/recorded/interpreted by highly skilled professionals, they are all subject to bias (+/-) and error. The result is we are faced with some level of subjectivity-uncertainty in measuring baseline cognitive skills and any changes.

I claim that unless some rational, detailed and fact based direct measurement is used to evaluate treatment efficacy then no clinical progress can/will be made. Additionally, reliance on systems like PET SCAN and MRI will rely on largely subjective and dubious inductive value in evaluation of ROOT CAUSE.

Cannot help but think that the LAST THING BIG P really wants in a trial system is ACTIGRAPHY and the detailed direct readout results/consequences (intended or not) of the clinical discovery/learning is the finite detailed discovery/learning which invariably follows such tools in a clinical setting. Clinical detail invariably begets more detail until a useful process and evaluative tool-suite is ultimately found and agreed to. (SEM/MRI/PET/ many examples)

SO WHAT YOU SAY. Well, guess what 800 lb. GORILLA DR.M./AVXL-PDD has in his closet about to release. This may be the beginning of the end or end of the beginning for effective CNS disease treatment. IMO, any publication (peer reviewed or not) from PDD trial w/Actigraphy content will be HUGELY important...possible presenting BTD material.

Results: Data of 31 patients (age, M ± SEM: 74.1 ± 1.5; 18 women, 13 men; Clinical Dementia Rating: 0-1) were analysed. One had been diagnosed with subjective cognitive impairment, 13 with mild cognitive impairment with or without depression, and 17 with dementia syndrome due to Alzheimer's and/or cerebrovascular disease. Compared to patients with subjective or mild cognitive impairment, dementia patients showed a significantly increased nocturnal acceleration magnitude; other differences in subjective and objective sleep measures were not significant. Comparing patients with subjectively poor (Pittsburgh Sleep Quality Index > 5: n = 9) and good sleep (Pittsburgh Sleep Quality Index ≤ 5: n = 22) yielded no differences in any neuropsychological and clinical variables. In contrast, patients with low actigraphically recorded sleep efficiency (<85%: n = 11) exhibited a significantly more impaired cognitive performance than those in the high sleep efficiency group (≥85%: n = 20). Correlation analyses demonstrated that actigraphically assessed disturbed sleep continuity accompanied by increased night-time motor activity was substantially associated with cognitive impairment.

Conclusion: This study highlights that objectively assessed, but not self-reported, parameters of disturbed sleep are closely related to cognitive dysfunction in the early stages of dementia of different aetiologies. Possible diagnostic and treatment implications are discussed.

WHAT IF, a treatment for CNS diseases be measured accurately and reported w/highest confidence w/in weeks of treatment result in massive changes in our entire medical system WW? Of Course. Our failed legacy of 5 years for a trial is dead. It is time to move on.