Anavex Life Sciences Corp (AVXL)

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Blarcamesine Didn’t Fix Patients’ ADLs. Does It Matter?

Yes, the trial results from blarcamesine being tested in early-stage Alzheimer’s disease showed significant statistical significance for three of the four matters being assessed. Meaning, that for those three Alzheimer’s problems the drug provided significant therapeutic outcomes. For them, the drug works, safely.

But blarcamesine didn’t achieve, even closely, statistical significance on the “ADL” test. It had a reading of p=0.234. To be statistically significant, meaning that the result was authentically therapeutic, not some random-chance result, the p-value had to be p=0.05 or less. The blarcamesine against early-stage Alzheimer’s ADL factor failed miserably; way too high, nowhere near 0.5 or less.

Should this matter? Does blarcamesine’s ADL treatment failure indicate that the drug should not be approved as a treatment for early-stage Alzheimer’s? It’s important to consider what, in medical practice and research, “ADL” is: “activities of daily living.”

Consider them:

Common activities of daily living (ADLs) include feeding oneself, bathing, dressing, grooming, working, homemaking, and managing personal hygiene after using the toilet.

https://en.wikipedia.org/wiki/Activities_of_daily_living

I have extensive personal experience with the problem. Over about 10 years my father suffered and finally died of medically-diagnosed Alzheimer’s disease.

For the first 6 or 7 years he had virtually no “ADLs.” As it happened, my mother was an experienced registered nurse in a recognized neurodegenerative and brain-injury clinic. She knew the symptoms, course, and sequellae of Alzheimer’s patients. She was a medical professional who cared for such patients. She knew what Dad had, and how it would end up.

Simply, as is the case with virtually all early-stage Alzheimer’s patients, the recognized “activities of daily living” of my father were essentially unhindered. Cognitively, he very slowly became compromised; having to give up and sell off his accountancy practice. But he didn’t suffer from diminished daily activities until much later, when he had to be institutionalized.

What might have happened if Dad could have been treated with blarcamesine at the very earliest point, when medical testing of cognition showed what he had; and what was to come?

As others have mentioned, testing for drug efficacy against ADLs in early-stage Alzheimer’s patients yields no useful information. Simply, activities of daily living aren’t compromised at the start of Alzheimer’s — at the stage where blarcamesine will be therapeutically most effective.