DATA ACDS-ADL data -- not understood by market yet IMO .. to the extent of
how important and "meaningful" this data is ....
"As noted in umpteen posts I've made, donepezil has proven both that placebo AND donepezil have shown statistical significance (proven in clinical treatment/disease parlance) to result in DECLINE from baseline in patient ACDS-ADL scores. So in fact has RVT-101, and the FDA has determined themselves that a) whatever minor lessening of the decline DZP provides it is insignificant to patients actual Activities of Daily Living (walking, feeding, continence, dressing, etc) over time AND that regardless it only results in decline, not improvement from baseline.
Much was made of the fact that Avanex's (IMHO groundbreaking) results in IMPROVING 11 of 14 patients was not *statistically significant* since it was not observed vs placebo groups. Clearly the next step is more patients over more time vs controls including dpz and control BUT the odds of this occuring as I've pointed out are TRILLIONS to one.
I've pointed out that both DPZ and RVT have done large-scale and long-term studies vs placebo (and one another) giving us a great data set of placebo i.e. untreated patients who believe they may be being treated as a comparative data-set.
Other HUGE datasets have proven that ADL scores decline over time for dementia patients. Feel free to review ncbiDOTnlmDOTnihDOTgov/pmc/articles/PMC1522014/ which was done on a cross-section of 66,742 patients across the US. (n ~ 6,000).
"a mean decline in ADL off 1.78 and 1.70"
"change of 1 point in denotes a clinically meaningful change..defined.. as a change in the abilities of an individual, but also a change in the cost of their care"
Despite the mean decline, 10% of patients showed some improvement. Avanex showed mean INCREASE o over THREE points and *80% * improvement.
FDA study for 'Memantine', 252 vs 84 placebo MINUS 4 vs MINUS 9 placebo
The placebo ACDS-ADL regression results are HUGELY stat sig, every drug tested ditto. 12 weeks might not be enough to "prove" but 3 point mean and 80% patients is HUGE Less
and to clarify:
"change of 1 point in denotes a clinically meaningful change..defined.. as a change in the abilities of an individual, but also a change in the cost of their care"
Avanex showed increase in over THREE points. And again this is an increase from BASELINE i.e. from when the drug was administered to the patient. In twelve weeks. When ONE point is defined as meaningful and a change in abilities and cost of their care. If this highly unlikely results on 14 patients carries through to 26 weeks and on more patients, this will be life changing hope for Alzheimers patients that doesn't exist. Think this scares some people? I do."
